[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psoriatic-arthritis-psa\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psoriatic-arthritis-psa":716},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,52,88,116,145,172,214,238,258,284,370,390,415,443,470,491,521,549,573,597,616,648,679,703],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100627972","phase-1-study-of-s-4321-in-participants-with-an-autoimmune-or-immune-mediated-disease-100627972",false,"NCT07455578","Study of S-4321 in Participants With an Autoimmune or Immune-mediated Disease","Phase 1b, Open-Label, Exploratory Biomarker Basket Study of S-4321 in Participants With an Autoimmune or Immune-Mediated Disease","All Participants Major Inclusion Criteria:\n\n1. Adult males and females, 18 to 75 years of age (inclusive)\n2. Body mass index (BMI) ≥18.0 and \\\u003C40.0 kg\u002Fm2 with a minimum body weight of 45 kg\n3. Use of adequate contraception for both males and females. Female volunteers must be of nonchildbearing potential or if of childbearing potential, must have a negative pregnancy test.\n\nAll Participants Major Exclusion Criteria:\n\n1. Have received a PD-1 agonist, immune checkpoint agonist, immune checkpoint inhibitor, anti-CD19 or anti-CD20 agents, cell therapy, B cell modulating agents, alkylating agents, or any other immune cell depleting therapy.\n2. Have received azathioprine, cyclosporine, mycophenolate mofetil, or tacrolimus within 4 weeks\n3. Unable or unwilling to discontinue a prohibited medication\n4. Presence of clinically relevant immunosuppression\n5. Current infection or history of severe infection\n6. Any history of malignant disease, with some exceptions\n\nMajor inclusion\u002Fexclusion for each autoimmune or immune-mediated disease:\n\nFor RA:\n\n1. Confirmed diagnosis of moderate to severe active RA by the American College of Rheumatology (ACR) 2010\u002FEuropean League Against Rheumatism (EULAR) criteria for at least 3 months prior to the Screening 1 visit, and:\n\n   1. ≥6 swollen joint count based on 66 joint count\n   2. ≥6 tender joint count based on 68 joint count\n   3. Seropositive for RF and\u002For ACPA\n   4. Elevated hsCRP ≥1.2 times greater than the ULN\n   5. Does not have Class IV RA according to ACR revised criteria\n2. Inadequate response to, or loss of response, or intolerance to:\n\n   1. \\>1 conventional synthetic DMARD after 3 months of therapy OR\n   2. \\>1 biologic DMARD\u002Ftargeted synthetic DMARD after 3 months of therapy\n   3. Has not failed 3 or more bDMARDs and\u002For tsDMARDs\n\nFor PsA:\n\n1. Confirmed diagnosis of adult-onset PsA classified by the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 3 months prior to the Screening 1 visit, with all of the following:\n\n   1. Active PsO defined by at least 1 psoriasis lesion\n   2. Active disease defined by \\>3 swollen joints and \\>3 tender joints using the 76\u002F78 swollen and tender joint count\n2. Received standard doses of NSAIDs for \\>4 weeks or csDMARDs for \\>3 months and has been on a stable dose for \\>8 weeks, or participant has intolerance to NSAIDs or DMARDs\n3. Participants may be TNF inhibitor therapy naïve or may have received 1 prior TNF inhibitor\n4. Has not had inadequate response or intolerance to 2 or more bDMARDs or csDMARDs\n\nFor PsO:\n\n1. Confirmed diagnosis of moderate to severe plaque PsO for at least 6 months, with all of the following:\n\n   1. Psoriasis Area and Severity Index (PASI) \\>12 points\n   2. Static Physician's Global Assessment (sPGA) \\>3 points\n   3. Body surface area (BSA) of PsO involvement \\>10%\n2. Cannot have a clinically significant flare within 12 weeks\n3. Does not have history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis\n4. Has not had inadequate response to more than 2 prior bDMARDs\n\nFor CLE (with or without systemic manifestations):\n\n1. Histologically confirmed diagnosis of CLE with or without systemic manifestations for at least 6 months\n2. Has active skin manifestations as measured by CLASI-A \\>10 or CLASI-A \\>8, if there is no alopecia or mucous membrane lesions\n3. Participant must have an active CLE lesion despite an adequate trial of antimalarial treatment for at least 6 months.\n4. Cannot have active lupus nephritis or moderate-to-severe or chronic kidney disease with eGFR \\\u003C45 mL\u002Fmin\u002F1.73m2\n5. Cannot have active neuropsychiatric SLE\n\nFor AD:\n\n1. Confirmed diagnosis of AD as defined by the American Academy of Dermatology: Guidelines of Care for the Management of Atopic Dermatitis for at least 12 months\n\n   1. Eczema Area and Severity Index (EASI) \\>16\n   2. Validated Investigator Global Assessment (vIGA-AD) \\>3\n   3. BSA of AD involvement \\>10%\n   4. PP-NRS) \\>4 (average of daily scores) during the 7 days prior to dosing\n2. Inadequate response to existing topical medications within 6 months or has a history of intolerance to topical therapy as defined by at least 1 of the following:\n\n   1. Inability to achieve good disease control after use TCS for at least 4 weeks\n   2. Documented history of clinically significant AEs with the use of TCS\n   3. Failed systemic therapies intended to treat AD within 6 months\n\nAdditional inclusion\u002Fexclusion criteria will apply.","ALL","18 Years","75 Years",{"count":5,"type":20},"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a multi-center, open-label Ph 1b basket study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarker response, and preliminary efficacy of multiple doses of S-4321 in adults with autoimmune or immune-mediated disease including rheumatoid arthritis (RA), psoriatic arthritis (PsA), psoriasis (PsO), cutaneous lupus erythematosus (CLE) with or without systemic manifestations, or atopic dermatitis (AD).",[26,27,28,29,30,31],"Autoimmune Diseases","Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)","Psoriasis (PsO)","Cutaneous Lupus Erythematosus (CLE)","Atopic Dermatitis (AD)",[33,34,35,36,37,31,29,28,30,38],"Autoimmune","Immune-mediated","S-4321","Seismic Therapeutic","Rheumatoid Arthritis","Cutaneous Lupus","RECRUITING","2026-05-28",{"date":42,"type":43},"2026-06-01","ACTUAL",{"date":45,"type":20},"2026-06",{"date":47,"type":20},"2027-09",{"name":49,"class":50},"Seismic Therapeutic AU Pty Ltd","INDUSTRY",2,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":72,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100638937","phase-4-carotid-ultrasound-based-strategy-for-primary-prevention-of-cardiovascular-events-in-inflammatory-rheumatic-disease-prevener-100638937","NCT07611747","Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)","Randomized Clinical Trial to Assess the Efficacy and Safety of a Primary Prevention Strategy for Cardiovascular Events in Patients With Inflammatory Rheumatic Diseases Based on the Use of Carotid Ultrasound","PREVENER","Inclusion Criteria:\n\n1. Patients aged ≥50 years who have provided written informed consent.\n2. Fulfillment of classification criteria for at least one of the following inflammatory rheumatic diseases:\n\n   * Rheumatoid arthritis (RA) according to ACR\u002FEULAR 2010 criteria\n   * Psoriatic arthritis (PsA) according to CASPAR criteria\n   * Axial spondyloarthritis (AxSpA) according to ASAS criteria\n   * Systemic lupus erythematosus (SLE) according to ACR\u002FEULAR 2019 criteria\n3. Low-to-moderate cardiovascular risk according to SCORE2\u002FOP classification.\n\nExclusion Criteria:\n\n1. Presence of previous cardiovascular events, type 2 diabetes mellitus, familial hypercholesterolemia, or chronic kidney disease resulting in classification as high or very high cardiovascular risk.\n2. Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or routine clinical practice.\n3. Contraindications to lipid-lowering therapy, including recent history of alcoholism, active liver disease, or unexplained and persistent elevation of serum transaminases exceeding three times the upper limit of normal (applicable to statins and ezetimibe).","50 Years",{"count":62,"type":20},1944,[64],"PHASE4","PREVENER is a randomized, open-label, multicenter, phase IV clinical trial designed to evaluate the efficacy and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD).\n\nPatients with IRD, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and systemic lupus erythematosus (SLE), have a 50% higher risk of cardiovascular (CV) events compared to the general population. However, conventional CV risk scores (SCORE2\u002FOP) systematically underestimate this risk, leaving many high-risk patients without appropriate preventive treatment.\n\nPatients aged ≥50 years with IRD and low-to-moderate CV risk according to SCORE2\u002FOP will be randomized 1:1 to either an experimental group (carotid ultrasound to detect subclinical atherosclerosis) or a control group (standard care according to ESC 2021 guidelines). Patients in the experimental group with carotid plaques will be reclassified as very high CV risk and treated with high-intensity statins (LDL target \\\u003C55 mg\u002FdL). The primary endpoint is the incidence of major adverse cardiovascular events (MACE) over 48 months of follow-up.",[27,28,67,68,69,70,71],"Axial Spondy","Systemic Lupus Erythematosus (SLE)","Caridovascular Disease","Atherosclerosis","Carotid Artery Diseases",[73,74,75,76,77],"Carotid ultrasound","Carotid plaques","Subclinical atherosclerosis","Cardiovascular prevention","Inflammatory rheumatic diseases","2026-05-20",{"date":40,"type":43},{"date":81,"type":43},"2026-04-22",{"date":83,"type":20},"2031-12",{"name":85,"class":86},"Instituto de Investigación Marqués de Valdecilla","OTHER",17,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100627078","combination-of-biologic-and-anti-obesity-therapies-in-psoriatic-arthritis-100627078","NCT07443956","Combination of Biologic and Anti-obesity Therapies in Psoriatic Arthritis","COMBAT-PsA","Inclusion Criteria:\n\n1. Age \\>= 18 years and \\\u003C=75 years\n2. Have a documented diagnosis of PsA for at least 6 months AND fulfil the CASPAR criteria (Defined as \\>=3 points)\n3. Have active PsA defined as \\>=3 swollen and \\>=3 tender joints (dactylitis counts as a swollen joint).\n4. Have a BMI \\>= 27 kg\u002Fm\\^2\n5. Have at least one affected joint amenable to ultrasound-guided synovial biopsy (and must undergo successful synovial biopsy prior to randomisation)\n6. Have at least one psoriatic plaque amenable to biopsy (up to a maximum of 5 participants per treatment arm can be recruited without skin biopsy if no suitable lesion\n7. Capable of giving signed informed consent\n8. Willing and able to participate in the study and undergo synovial, adipose and skin (if appropriate) biopsies (under local anaesthetic) on at least 2 occasions\n\nExclusion Criteria:\n\nPrior\u002FConcomitant Therapy:\n\n1. Previous treatment with tirzepatide or any GLP-1 receptor agonist.\n2. Previous treatment with Ixekizumab.\n3. Previous treatment with BOTH secukinumab AND Bimekizumab. \\[note: Previous treatment with one of EITHER secukinumab OR Bimekizumab for PsA\u002Fpsoriasis is allowed PROVIDED: i) Last dose was \\>6months before baseline AND ii) Therapy was not stopped due to an IL-17-related side effect OR due to complete primary lack of response.\n4. Previous treatment with rituximab.\n5. Failed \\>3 classes of advanced therapies (regardless of given for PsA or psoriasis), including but not limited to:\n\n   * TNF inhibitors (adalimumab, etanercept, certolizumab, golimumab, and infliximab)\n   * IL-12\u002F23 inhibitors (ustekinumab)\n   * IL-23 inhibitors (guselkumab and risankizumab)\n   * IL-17 Inhibitors (secukinumab or bimekizumab)\n   * Selective co-stimulation modulators (abatacept)\n   * Janus Kinase or tyrosine kinase 2 inhibitors (tofacitinib, upadacitinib and deucravacitinib) Note: Prior exposure to phosphodiesterase-4 inhibitors, such as apremilast and conventional synthetic DMARDs, such as methotrexate, are not considered as advanced therapies.\n6. If currently receiving conventional DMARDs, or apremilast, must have been treated for at least 12 weeks prior to first biopsy visit and on a stable dose for at least 8 weeks prior to first biopsy visit.\n7. Use or oral, intra-articular, IM or IV corticosteroids 4 weeks prior to first biopsy visit or anticipated\u002Fplanned prior to the week 12 biopsy visit.\n8. Topical steroids within 2 weeks of first biopsy visit (participants on topical corticosteroids at baseline willing to leave these off 2 weeks prior to biopsy will be eligible).\n9. Live, attenuated or recombinant vaccination within 1 month prior to screening visit or planned before the 12 week visit.\n10. Contraindication to local anaesthetics (lidocaine\u002Fsimilar) used for biopsies\n11. Antiplatelet or anticoagulant therapy that cannot be safely interrupted:\n\n    1. Clopidogrel or other antiplatelet therapies (note: aspirin is not an exclusion)\n    2. Vitamin K antagonists (including but not limited to warfarin)\n    3. Direct inhibitors of thrombin (e.g. dabigatran)\n    4. Factor Xa inhibitors (e.g. rivaroxaban, apixaban)\n    5. Heparins (including low-molecular weight heparins (LMWH)\n12. Previous treatment with insulin (exception: Use of insulin for gestational diabetes or short-term use (less than 14 days) for acute conditions, such as acute illness, hospitalisation or elective surgery).\n\n    Medical Conditions:\n13. Diagnosis of type 1 diabetes or insulin treated type 2 diabetes.\n14. History of severe hypoglycaemia and\u002For hypoglycaemia unawareness within the 6 months prior to screening.\n15. History of ketoacidosis or hyperosmolar state or coma in the last year\n16. Any current or past diagnosis of:\n\n    * proliferative diabetic retinopathy, or\n    * diabetic maculopathy, or\n    * non-proliferative diabetic retinopathy that requires treatment.\n17. Have a self-reported change in body weight greater than 5% (gain or loss) within 3 months prior to screening.\n18. Prior or planned surgical treatment for obesity, such as gastric bypass (bariatric) surgery or restrictive bariatric surgery (excluding liposuction or abdominoplasty if performed more than 1 year prior to screening).\n19. Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2.\n20. History of IBD (Crohn's disease or ulcerative colitis).\n21. Known clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction); or chronically take drugs that directly effect gastroparesis.\n22. History of chronic or acute pancreatitis.\n23. Renal Impairment with estimated glomerular filtration rate (GFR) of less than or equal to 30ml\u002Fmin\u002F1.73m\\^2.\n24. A diagnosis or history of malignant disease within 5 years prior to baseline visit, with the following exceptions:\n\n    * Basal cell and squamous epithelial carcinomas of the skin that have been resected, with no evidence of metastatic disease for 3 years and 2 years, respectively.\n    * cervical carcinoma in situ, with no evidence of recurrence within 3 years.\n25. History of any other condition (such as known drug, alcohol abuse, or psychiatric disorder) that, in the opinion of the investigator, may preclude the participant from following and completing the study.\n26. History of significant active or unstable major depressive disorder (MDD), suicidal ideation, or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years.\n\n    Note: Participants with MDD or generalised anxiety disorder whose disease state is considered stable for the past year and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if they are not on excluded medications.\n27. Are, in the judgement of the investigator, actively suicidal or deemed to be at significant risk for suicide.\n28. Diagnosis of other inflammatory arthritis, such as rheumatoid arthritis, ankylosing spondylitis, reactive arthritis, gout, or enteropathic arthritis.\n29. Active infection at screening.\n30. Have had any of the following types of infection within 3 months prior to screening or develops any of the following infections before the baseline visit:\n\n    * Serious (requiring hospitalisation, or intravenous or equivalent oral antibiotic treatment, or both).\n    * Opportunistic. Note: Herpes Zoster is considered active and ongoing until all vesicles are dry and crusted over).\n    * Chronic (duration of symptoms, signs and\u002For treatment of 6 weeks or longer).\n    * recurring (including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, and chronic osteomyelitis).\n31. Have evidence or suspicion of active or latent TB (unless screened previously, all will be evaluated for TB prior to initiating treatment) or had latent TB infection that has not been treated with a complete course of appropriate therapy as per local guidelines, unless such therapy is currently underway.\n32. Current HIV infection.\n33. Current infection with hepatitis B virus (HBV) (i.e. positive for HBsAg and\u002For PCR positive for HBV DNA).\n34. Current infection with hepatitis C virus (HCV) (i.e. positive for HCV RNA).\n35. History of recurrent or chronic infection which in the opinion of the investigator might place a participant at unacceptable risk for participation in the study.\n36. Major surgery witing 8 weeks prior to screening or planned within 12 weeks from baseline visit.\n37. Any other condition that is a contraindication to ixekizumab or tirzepatide.\n\n    Laboratory results:\n38. If type 2 diabetic, laboratory evidence of poorly controlled diabetes, including HbA1c \\>80mmol\u002Fmol (\\>9.5%).\n39. Clinical laboratory test results at screening that are outside the normal reference range for the population and are considered clinically significant, or have any of the following specific abnormalities:\n\n    * Absolute neutrophil count \\\u003C1.5 x 10\\^3\u002Fmicrolitre\n    * Lymphocyte count \\\u003C0.80 x 10\\^3\u002Fmicrolitre\n    * Platelet count \\\u003C100 x 10\\^3\u002Fmicrolitre\n    * Total WBC count \\\u003C3.00 x 10\\^3\u002Fmicrolitre\n    * Haemoglobin \\\u003C85 g\u002FL (males) or \\\u003C80g\u002FL (females)\n    * AST or ALT levels \\>3 x upper limit of local normal range\n    * Serum creatinine levels \\>2.0omg\u002FdL (equivalent to \\>176.8 micromol\u002FL Participants who fail screening as a result of a minor blood test abnormality\u002Fabnormalities may be re-screened and have the test(s) repeated, within 14 days of the previous blood test, at the investigators discretion. If the tests meet the trial entry criteria on the second occasion, then the participant will be deemed to meet the entry criteria for the trial.\n\n    In women of child bearing potential(WOCBP):\n40. Are Pregnant, breastfeeding or planning to become pregnant during the course of the study.\n41. Not established, or unwilling to use a method of contraception considered highly effective for the duration of the study and at least 4 weeks after the study if they receive tirzepatide, or 10 weeks if they receive ixekizumab. Tirzepatide may decrease the effectiveness of oral contraceptives, so it is advised that WOCBP using an oral contraceptive should add a barrier method of contraception or switch to a non-oral contraceptive method for the first 4 weeks of treatment, and for 4 weeks after each dose increase.\n\n    Other exclusions:\n42. Have participated, within the last 30 days prior to trial entry, in a clinical study involving an investigational study intervention. If the previous investigational study intervention has a long half life, then 5 half lives or 30 days (whichever is longer), should have passed prior to screening.\n43. Are currently enrolled in any other clinical study involving an investigational study intervention or any other type of medical research judged not to be scientifically or medically compatible with this study.\n44. Unable or unwilling to provide informed consent.\n45. Are unsuitable for inclusion in the study, in the opinion of the investigator or sponsor, for any reason that may compromise the participant's safety or confound data interpretation.\n46. Any other contra-indications to biopsies (including anti-coagulants) in the opinion of the investigator.",{"count":96,"type":20},45,[98],"NA","This is a trial to find out how weight loss (achieved by the use of tirzepatide) or ixekizumab treatment affects the characteristics of skin, joint and fat tissues in patients with Psoriatic Arthritis, Psoriasis and obesity\u002Foverweight BMI \\>=27.\n\nParticipants will be allocated either Tirzepatide, Ixekizumab or both. Samples of joint tissue, fat and skin will be taken at the start of the study and week 12. Blood and urine samples will also be taken.\n\nThe primary objective will be to assess the changes seen in the joint, fat and skin tissue samples 12 weeks after starting the medications (additional analysis will be done on the optional 36 week samples).\n\nSecondary objectives will be\n\n* To assess the changes seen in blood 4, 12, 36 and 52 weeks after starting the medication.\n* To compare the changes seen in tissue and blood between Ixekizumab and Tirzepatide\u002FWeight loss.\n* To see how the changes seen in the tissue relate to weight loss.",[28,101],"Obesity & Overweight",[103,104,105],"Psoriatic Arthritis","Obesity","PsA","2026-04-28",{"date":108,"type":43},"2026-05-04",{"date":110,"type":43},"2026-03-09",{"date":112,"type":20},"2030-05",{"name":114,"class":86},"NHS Greater Glasgow and Clyde",4,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100634195","oxidative-stress-in-autoimmune-rheumatic-diseases-100634195","NCT07536529","Oxidative Stress in Autoimmune Rheumatic Diseases","Investigation of the Role of Redox Status of Patients With Autoimmune Rheumatic Diseases on Disease Progression: An Epidemiological Study","REDOX-ARD","Inclusion Criteria:\n\n* Adult patients (\\>18 years old), with a primary diagnosis of rheumatoid arthritis using the criteria of American College of Rheumatology (ACR)\n* Adult patients (\\>18 years old), with a primary diagnosis of psoriatic arthritis using the ClASsification criteria for Psoriatic Arthritis (CASPAR)\n* Adult patients (\\>18 years old), with a primary diagnosis of alkylosing spondyloarthritis using the criteria of Assessment of SpondyloArthritis international Society (ASAS) group\n* Adult patients (\\>18 years old) irrespective of gender\n* Adult patients (\\>18 years old) irrespective of ethnicity\n* Adult patients (\\>18 years old) irrespective of comorbidities\n* Adult patients (\\>18 years old) irrespective of socioeconomic background\n* Adult patients (\\>18 years old) with any disease status\n* Adult patients (\\>18 years old) with any disease duration\n* Adult patients (\\>18 years old) under any treatment scheme (e.g. non-steroidal anti-inflammatory drugs, steroids, disease-modifying anti-rheumatic drugs including biologics)\n\nExclusion Criteria:\n\n* Adult patients (\\>18 years old) with concurrent infectious disease\n* Adult patients (\\>18 years old) in pregnancy\n* Patients under 18 years of age",{"count":125,"type":20},200,"OBSERVATIONAL","Rheumatic diseases constitute a group of non-communicable diseases characterized by chronic inflammation. The most common autoimmune rheumatic diseases (ARDs) are rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, myositis, Sjogren's syndrome and systemic scleroderma. These autoimmune disorders lead to joint destruction and adversely influence the human body systemically. One of their characteristics is comorbidity, since patients usually suffer also from other pathologies such as cardiovascular diseases and obesity. In addition, their treatment requires a combination of both biological and conventional pharmaceutical interventions as well as other parameters such as physical activity programs, nutrition, and the use of smart electronic devices. Therefore, the ARDs burden health systems worldwide. Apart from the physiological manifestations of ARDs, specific changes are observed at the cellular and molecular level. A common biochemical\u002Fmolecular symptom of these diseases is oxidative stress. This condition leads to the disturbance of blood and tissue redox status due to the excessive production of free radicals. Given that free radicals are highly reactive moieties with strong oxidative capacity against biomolecules (i.e., proteins, lipids, DNA), they compromise the efficacy of the intrinsic antioxidant mechanisms and, finally, induce the disruption of redox homeostasis. However, there is no sufficient data linking the levels of redox status of patients with the progression of ARDs over time. Indeed, the onset and symptoms of ARDs are intertwined with the disruption of the patient redox homeostasis and the induction of oxidative stress. Concurrently, the absence of a completely effective pharmaceutical treatment emerges the need for the adoption of novel biomarkers for monitoring the severity of the symptoms and the evolution of ARDs in general. To that end, this study aims at first to investigate the blood redox status of patients with ARDs. Thus, specific redox biomarkers will be evaluated in the blood of patients in three time points (i.e., at Days 1, 180 and 360), and they will be associated with the clinical manifestations of their diseases. The ultimate goal is to clarify whether these biomarkers could putatively exert clinical significance, namely whether they could constitute an additional tool for the monitoring of the progression of these diseases in clinical practice.",[129,27,28,130],"Inflammatory Joint Diseases","Ankylosing Spondylitis (AS)",[132,133,134,135,136],"Rheumatoid arthritis","Psoriatic arthritis","Ankylosing spondylitis","Oxidative stress","Antioxidants",{"date":106,"type":43},{"date":139,"type":43},"2025-10-06",{"date":141,"type":20},"2026-10",{"name":143,"class":86},"University of Thessaly",1,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100344715","apache-cohort-a-psoriatic-arthritis-cohort-100344715","NCT03768271","APACHE Cohort (A Psoriatic Arthritis CoHort)","French Cohort on the Becoming of Recent Articular Psoriatic Rheumatism (A Psoriatic Arthritis CoHort)","APACHE","Inclusion Criteria:\n\n* Women or men aged from 18 to 65 inclusive\n* First episode of peripheral arthritis in the last 12 months, authenticated by a rheumatologist\n* Psoriasis diagnosed by a practitioner or family history of psoriatic arthritis (first-degree relative \\[parent or sibling\\] or second degree relative)\n* Arthritis most likely recognized as a psoriatic arthritis by a rheumatologist (diagnostic confidence score : ≥ 7 out of 10)\n* Signed informed consent form\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Formal diagnostic of inflammatory rheumatism other than psoriatic arthritis\n* Treatment or history of treatment with a biomedicine\n* Patient receiving csDMARDS (methotrexate, sulfasalazine, or leflunomide) or apremilast treatment over the past year for rheumatological symptoms\n* Oral steroids in the last 4 weeks, above 10 mg\u002Fd of prednisone or with modified dosage\n* intravenous or intra articular steroids in the last 4 weeks\n* IRM contraindication\n* Cognitive, mental or psychic disorders impeding protocol accomplishment\n* Difficulties with French language understanding\n* Patient under tutorship or curatorship\n* Pregnancy","65 Years",{"count":155,"type":20},425,"Psoriatic arthritis (PsA) is a chronic inflammatory rheumatic disease, belonging to the wide spectrum of spondyloarthritis, but with the particularity to be associated with personal psoriasis or familial psoriasis. PsA can be a very disabling disease through progressive and irreversible joint damage. Long-term functional prognosis of patients with PsA is correlated with the presence and severity of the radiographic joint lesions of the disease.\n\nHowever, the proportion of patients who will develop those peripheral joint damages is not yet known and less over the factors which are associated\u002Finvolved in such an aggressive pattern of the disease. Early identification of this subgroup of patients is particularly important for determining early \"intensive\" treatment, strict management with a Treat To Target approach, and identification of new treatments with a stronger structural effect.\n\nThe main objective of this prospective 10 years cohort is to describe the 5 years structural (radiographic) severity of recent Psoriatic arthritis (PsA)with recent peripheral arthritis.Some of the secondary objectives are to describe the 10 years structural severity within those patients, and to determine the predictive factors of those 5 and 10 years radiographic lesions (genetic, environmental, clinic, therapeutic factors).\n\nAPACHE will provide a unique longitudinal standardized database concerning patients with PsA with very recent peripheral arthritis. Research projects which will based on those collected data should allow to identify the mechanisms of aggressive joint damage, to highlight mew treatments targets, to better describe the burden of the disease, to test previous or develop new assessments tolls, to develop early diagnostic criteria",[158,28,159],"Cohort Study","Recent Peripheral Arthritis",[161,162,133],"radiographic lesions","10 years cohort",{"date":164,"type":43},"2026-04-27",{"date":166,"type":43},"2020-02-12",{"date":168,"type":20},"2036-12-01",{"name":170,"class":86},"Assistance Publique - Hôpitaux de Paris",3,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":180,"sex":16,"minAge":181,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":197,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":51},"100599701","phase-4-safety-and-immunogenicity-of-the-live-attenuated-tetravalent-butantan-dengue-vaccine-in-autoimmune-rheumatic-diseases-100599701","NCT07087912","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas","BTNDV-ARD","Inclusion Criteria:\n\n* Age between 12 and 59 years\n* Male or female\n* Clinical diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted criteria (e.g., rheumatoid arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, Sjögren's syndrome, vasculitis)\n* Healthy control matched by age and sex\n* ARD patients with clinically stable disease for at least 3 months\n* ARD patients under low-grade immunosuppression or no immunosuppression\n* Acceptable immunosuppressive treatments include:\n\nHydroxychloroquine Sulfasalazine Prednisone ≤ 20 mg\u002Fday Methotrexate ≤ 0.4 mg\u002Fkg\u002Fweek (maximum 20 mg\u002Fweek) Leflunomide 20 mg\u002Fday Azathioprine \\\u003C 3 mg\u002Fkg\u002Fday Combination therapy with low-dose prednisone (≤ 7.5 mg\u002Fday), hydroxychloroquine, or sulfasalazine\n\n* Healthy controls with no history of autoimmune or chronic infectious diseases\n* Healthy controls not taking immunosuppressive medications Willing and able to comply with study procedures and follow-up\n* Female participants of reproductive potential with negative pregnancy test at baseline\n* Female participants of reproductive potential agreeing to use effective contraception for at least 90 days after vaccination\n\nExclusion Criteria:\n\n* Prior receipt of any dengue vaccine\n* Receipt of a live attenuated vaccine within 4 weeks prior to enrollment\n* Receipt of an inactivated vaccine within 2 weeks prior to enrollment\n* Known allergy to any component of the vaccine\n* Febrile illness (≥ 37.8°C) within 72 hours prior to vaccination\n* History of immunodeficiency syndromes\n* History of asplenia\n* History of cancer\n* History of HIV infection\n* History of primary immunodeficiencies\n* Immunosuppression due to organ transplant\n* Chronic uncontrolled comorbidities (e.g., heart failure, renal failure, hepatic insufficiency, diabetes mellitus)\n* Hospitalization or acute illness at screening\n* Receipt of blood transfusion within 3 months prior to enrollment\n* Current pregnancy or breastfeeding\n* Intention to become pregnant within 90 days post-vaccination\n* Participation in another clinical trial within 30 days prior to enrollment",true,"12 Years","59 Years",{"count":184,"type":20},477,[64],"The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age.\n\nThe main questions it aims to answer are:\n\nDoes the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs?\n\nResearchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles.\n\nAll participants will:\n\n* receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection;\n* undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses;\n* attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests;\n* report any symptoms or adverse events using a standardized diary for 42 days;\n* be followed for up to one year for long-term safety and immunogenicity assessments.\n* wear a device for 14 consecutive days to assess current and habitual physical activity levels.\n* answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status.\n* collect blood samples one-year after vaccination to access immunogenicity and cellular response.\n\nResearcher will also perform subgroups analysis in:\n\nA viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration.\n\nAn immunogenicity subgroup (\\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.",[27,188,68,189,190,191,192,28,193,194,195,196],"Juvenile Idiopathic Arthritis (JIA)","Juvenile Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)","Idiopathic Inflammatory Myopathies (IIMs)","Axial Spondyloarthritis","Granulomatosis With Polyangiitis","Microscopic Polyangiitis","Antiphospholipid Syndrome","Takayasu Arteritis",[198,199,200,201,202,203,204],"Tetravalent Vaccine","Butantan-Dengue Vaccine","Autoimmune Rheumatic Diseases","Rheumatology","Pediatric Rheumatology","Infectious Disease Prevention","Vaccine","2026-04-14",{"date":207,"type":43},"2026-04-15",{"date":209,"type":20},"2026-03-16",{"date":211,"type":20},"2028-12-30",{"name":213,"class":86},"University of Sao Paulo General Hospital",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":153,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":226,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":234,"leadSponsor":236,"locationsCount":144},"100614523","phase-4-deucravacitinib-tnfi-combination-therapy-for-difficult-to-control-psoriatic-disease-100614523","NCT07280702","Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease","COMBo","Inclusion Criteria:\n\n* Adults aged 18-65 with confirmed psoriatic arthritis based on CASPAR criteria.\n\n  * Ability to provide informed consent and comply with study procedures.\n  * Patients with plaque psoriasis BSA\\>3% OR PsA with \\[SJC\\>2 AND TJC \\>3\\] despite stable background anti-TNF therapy for at least 6 months, with or without csDMARDs (i.e MTX, leflunomide, sulfasalazine, hydroxychloroquine).\n  * Concurrent use of 1 csDMARD, and\u002For NSAID, and\u002For oral glucocorticoid is permitted but not required during the study. If such treatment was administered, then participants must meet the following requirements:\n\n    * If on csDMARD (methotrexate \\[MTX\\], sulfasalazine \\[SSZ\\], leflunomide \\[LEF\\], hydroxychloroquine \\[HCQ\\]), the participant must have been on it for at least 12 weeks and be on a stable dose for at least 28 days prior to Day 1.\n\n      * If on MTX, the route of administration and dose must be stable and the dose must be ≤ 25 mg\u002Fweek.\n      * If on SSZ, the dose must be ≤ 3 g\u002Fday.\n      * If on HCQ, the dose must be ≤ 400 mg\u002Fday.\n      * If on LEF, the dose must be ≤ 20 mg\u002Fday. Note: If currently not on MTX, SSZ, or HCQ, the participant must not have received it for at least 28 days prior to Day 1. If currently not on LEF, the participant must not have received it for at least 12 weeks prior to Day 1.\n    * If on an NSAID, the participant must be on a stable dose for at least 14 days prior to Day 1.\n    * Stable background use of prednisone 15 mg daily or equivalent is permitted. If on oral glucocorticoids, the participant must be on a stable dose of ≤ 15 mg\u002Fday prednisone equivalent for at least 28 days prior to Day 1.\n    * Note: If currently not on oral glucocorticoids, the participant must not have received oral glucocorticoids within 28 days prior to Day 1\n\nExclusion Criteria:\n\n* History of failure of more than two anti-TNF therapies, prior history of failure of TYK2 and JAK inhibitors.\n\n  * History of prior allergic reaction or intolerance to deucravacitinib.\n  * History of primary failure of anti-IL17, anti-IL23 is excluded. Note that prior exposure to these agents is allowed for reasons other than primary failure, eg intolerance, insurance \u002F access issues, etc).\n\n    * Systemic agents other than anti-TNF or csDMARD (ie. MTX, leflunomide, sulfasalazine, hydroxychloroquine) must have ceased \\> 6 months prior to baseline.\n    * Doses or glucocorticoids \\>15mg daily prednisone or equivalent.\n  * Severe cardiovascular, hepatic, or renal impairment.\n  * History or evidence of outpatient active infection and\u002For febrile illness within 14 days prior to Day 1.\n  * History of serious bacterial, fungal, or viral infection requiring hospitalization or parenteral antimicrobial treatment (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 60 days prior to Day 1.\n  * Receipt of any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria) at screening.\n  * Recent herpes zoster or herpes simplex infection or history of serious herpes zoster or herpes simplex infection defined as:\n  * a) Herpes zoster or herpes simplex lesions within 30 days prior to randomization, OR\n  * b) History of serious herpes zoster or serious herpes simplex infection, which includes, but it is not limited to, any episode of disseminated herpes simplex, multi- dermatomal herpes zoster, herpes encephalitis, ophthalmologic herpes, and\u002For recurrent herpes zoster (recurrent herpes zoster is defined as more than 2 episodes in the last 2 years).\n  * Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status (eg, history of opportunistic infections \\[eg, Pneumocystis jirovecii pneumonia, histoplasmosis, or coccidioidomycosis\\], history of splenectomy, primary immunodeficiency).\n  * Receipt of any live vaccine within 60 days prior to Day 1 or plans to receive a live vaccine during the study or within 60 days after completing study treatment.\n  * Evidence of, or positive testing for, hepatitis B virus or hepatitis C virus at screening.\n  * Positive testing for human immunodeficiency virus 1 or 2 by antibody testing at screening.\n  * History of active TB prior to the screening visit, signs or symptoms of active TB at screening, positive QuantiFERON®-TB Gold (or equivalent) test result or 2 successive indeterminate QuantiFERON®-TB Gold (or equivalent) test results at screening.\n  * History of chronic or recurrent infectious disease.\n  * History of VTE, MACE, active solid malignancy or history of malignancy \\\u003C5 years, any hematologic malignancy; history of multiple serious infections requiring hospitalization in the past 5 years, history of opportunistic infection, any condition which in the opinion of the investigator would pose a safety risk or inability to assess key endpoints in the study.\n  * History of fibromyalgia\u002Fcentral sensitization, or other joint disease which in the opinion of the investigator would make musculoskeletal disease activity assessment challenging in the context of this study.\n  * History of other inflammatory dermatosis which in the opinion of the investigator would make skin disease activity assessment challenging in the context of this study (eg atopic, contact dermatitis, etc).\n  * Exclude use of topicals except for mild to mid-potency topical steroids for use only in cosmetically sensitive areas such as the face.",{"count":222,"type":20},128,[64],"The purpose of this research study is to determine the effectiveness of adding deucravacitinib to the participant's current Psoriatic Arthritis (PsA) treatment to see if it improves their symptoms and quality of life.\n\nThis study is exploring a new treatment approach that may help improve control of psoriatic disease by targeting different parts of the disease process. By combining therapies that work together, the goal is to offer better symptom relief with fewer or more manageable side effects than some current treatments.",[28],[103,105,227,228],"Deucravacitinib","TNF","NOT_YET_RECRUITING","2026-04-06",{"date":232,"type":43},"2026-04-13",{"date":207,"type":20},{"date":235,"type":20},"2027-12-15",{"name":237,"class":86},"University of Texas Southwestern Medical Center",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":21,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":254,"leadSponsor":256,"locationsCount":144},"100630374","phase-4-preventing-structural-damage-in-early-psoriatic-arthritis-100630374","NCT07486843","Preventing Structural Damage in Early Psoriatic Arthritis","Methotrexate Versus TNF Inhibition in Preventing Structural Damage in Early Psoriatic Arthritis: A Randomized Trial Using HR-pQCT (MeTEPsA Trial)","Inclusion Criteria:\n\n* ≥18 years old\n* without severe deformity in MCPJ\n* with active disease, which is defined as ≥1 tender joints and ≥1 swollen joints, despite previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for ≥ 4 weeks\n* with at least one poor prognostic factor (eg, polyarthritis, structural damage on HR-pQCT or CR, elevated acute phase reactants, dactylitis, nail involvement or HAQ-DI\\>1)\n* symptom duration ≤ 2 years\n\nExclusion Criteria:\n\n* on csDMARDs unless being prescribed for skin psoriasis (e.g. cyclosporin)\n* limited in ability to perform usual self-care, vocational, and avocational activities\n* pregnancy\n* previous therapy with b\u002FtsDMARDs\n* predominant active axial PsA or significant uveitis\u002Finflammatory bowel disease requiring immediate b\u002FtsDMARDs therapy\n* the presence of active inflammatory diseases other than PsA\n* active infection in 2 weeks before randomization or a history of ongoing, chronic, or recurrent infections including tuberculosis\n* history of malignant disease within the past 5 years (excluding basal cell carcinoma or actinic keratosis, in-situ cervical cancer, or non-invasive malignant colon polyps)\n* contraindications to MTX or adalimumab",{"count":246,"type":20},108,[64],"Investigators hypothesize that TNFi is superior to SC MTX in preventing structural damage in early, treatment-naïve PsA, assessed using HR-pQCT. The study aims to ascertain:\n\n\\- The effect of SC MTX and TNFi (adalimumab biosimilar) on erosion and enthesiophyte progression in early PsA by HR-pQCT.\n\nParticipants will be:\n\n* Randomized in a 1:1 ratio to either the SC MTX group or the TNFi group.\n* HR-pQCT of MCPJ 2-4 will be performed at baseline, week 24, and one year.\n\nThe primary outcome is the comparison of change in erosion volume over MCPJ 2-4 across 48 weeks between the SC MTX group (group 1) and the TNFi group (group 2), assessed by HR-pQCT.",[28],"2026-03-18",{"date":252,"type":43},"2026-03-23",{"date":209,"type":43},{"date":255,"type":20},"2028-12-31",{"name":257,"class":86},"Chinese University of Hong Kong",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":273,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":144},"100628369","efficacy-of-a-self-management-smartphone-app-to-improve-safety-skills-in-patients-with-inflammatory-arthritis-100628369","NCT07460739","Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis","Efficacy of a Self-Management Smartphone App in Promoting Safety Skills of Patients With Inflammatory Arthritis Treated by Anti-Rheumatic Drugs","RHUMATOSMART","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Diagnosis of rheumatoid arthritis (RA) according to the 2010 ACR\u002FEULAR classification criteria of the American College of Rheumatology, or axial or peripheral spondyloarthritis (SpA) according to the 2009 ASAS criteria of the Assessment of SpondyloArthritis International Society, or psoriatic arthritis according to the 2009 CASPAR criteria.\n* Undergoing a treatment change to a tDMARD (biologic or JAK inhibitor) available in the SFR application.\n* No therapeutic education on tDMARDs in the past two years.\n* Ability to use a smartphone application.\n* Ability to use a website.\n* Ability to complete a questionnaire.\n* Signed informed consent for the study.\n* Covered by social security or entitled to social protection.\n\nExclusion Criteria:\n\n* Any condition that may affect comprehension or treatment adherence (chronic alcoholism, language barrier, severe psychiatric disorders, cognitive impairment).\n* Planned treatment with intravenous bDMARDs in the upcoming year.\n* Patients who have already downloaded self-management applications for their rheumatic disease.\n* Patients enrolled in a therapeutic education program: face-to-face education by a nurse or healthcare professional, or group education.\n* Patients who have already received therapeutic education on targeted DMARDs in the past two years: face-to-face education by a nurse or healthcare professional, or group education.\n* Participation in another interventional clinical trial\n* Pregnant or breast-feeding woman\n* Individual under legal protection (tutorship or guardianship) or deprived of freedom",{"count":267,"type":20},144,[98],"Rheumatoid arthritis (RA) and spondyloarthritis (SpA), including psoriatic arthritis (PsA), are chronic painful diseases that impair quality of life. Disease-modifying antirheumatic drugs (DMARDs) are used to control disease activity, reduce functional disability, and improve prognosis. These include conventional DMARDs such as methotrexate, as well as targeted DMARDs (tDMARDs), i.e., biological agents (bDMARDs) like anti-TNF alpha and JAK inhibitors. Patients treated with tDMARDs face a risk of adverse effects, including an increased risk of infections. Therapeutic patient education has been shown to help patients develop safety skills, but its effectiveness is only short-term.\n\nMobile health applications are increasingly used by patients to manage their health.\n\nThe French Society of Rheumatology (SFR) has developed a smartphone self-management application aimed at supporting people with inflammatory arthritis in managing their treatments, symptoms, and information needs. It provides advice on lifestyle and daily living, promotes treatment adherence, and enables self-assessment of disease status. The app includes seven features: a safety checklist before treatment administration, daily life aids based on French academic recommendations, treatment reminders, self-assessment of overall well-being, disease monitoring (pain, fatigue, patient global assessment of disease activity), periodic advisory messages, and a diary.\n\nThe application is not a medical device; collected data are stored on the user's smartphone. Patient data are not directly shared with physicians. Patients can use the app during consultations or share screenshots with their doctors. The app is more widely used and has a longer lifespan than most available apps, but its impact on patients still needs evaluation in a randomized controlled trial.\n\nThe primary hypothesis of the study is that using the app will improve safety skills in patients with inflammatory arthritis treated with tDMARDs compared to usual care, including access to the SFR patient information website.\n\nThe secondary hypothesis is that using the app will improve patient adherence and the patient-rheumatologist relationship.\n\nObjectives : To determine whether the mobile application improves patients' ability to acquire safety-related skills in the daily use of targeted disease-modifying antirheumatic drugs (tDMARDs), compared to usual care, including access to an informational website for patients.\n\nThe primary outcome will be the change in the BioSecure questionnaire score at 6 months after inclusion, comparing the group using the mobile application with the group using the informational website.",[271,272,28],"Rhumatoid Arthisis","Spondyloarthritis (SA)",[271,274,103,275],"spondyloarthritis","Mobile Application","2026-03-11",{"date":278,"type":43},"2026-03-13",{"date":280,"type":20},"2026-03",{"date":282,"type":20},"2027-04",{"name":170,"class":86},{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":180,"sex":16,"minAge":291,"maxAge":4,"enrollmentInfo":292,"targetDuration":294,"studyType":126,"phases":4,"briefSummary":295,"conditions":296,"keywords":338,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":144},"100424417","unhide-project-a-digital-health-platform-to-collect-lifestyle-data-for-brain-inflammation-research-100424417","NCT04806620","Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research","Unhide® Project Also Known as The Unhide® Solve Together Unified Platform","Participants may be either self-diagnosed, or diagnosed by a physician with the following conditions:\n\n* Infection-associated chronic conditions such as Long COVID, chronic Lyme, myalgic encephalomyelitis (ME\u002FCFS), and post-acute neuropsychiatric syndrome (PANS\u002FPANDAS).\n* Neuroimmune, developmental, autonomic, and neurological conditions like migraines, dysautonomia, POTS, multiple sclerosis, and autism spectrum disorder.\n* Autoimmune diseases such as Lupus, Sjogren's Disease, rheumatoid arthritis, myasthenia gravis, ankylosing spondylitis, and related autoimmune conditions.\n\nInflammatory gastrointestinal conditions such as Crohn's Disease, Celiac Disease, and ulcerative colitis.\n\n* Behavioral and mood disorders such as anxiety, depression, bipolar disorder, PTSD, eating disorders, OCD, and other related conditions.\n* \"Healthy\" people (without brain inflammation), including unaffected individuals, unaffected individuals in the same household, and unaffected individuals who are married to relatives and family members.\n* Have consistent internet access and a cell phone, tablet, or PC since this is an online or app-based platform that requires entering data and completing surveys.\n* Currently live in the United States\n* Be able to participate in English (stay tuned for updates about the Spanish language version)\n* Be willing to share symptom and health data through the platform","2 Years",{"count":293,"type":20},10000,"10 Years","The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. \"Healthy\" individuals without brain inflammation are also eligible to participate.\n\nThe digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.",[297,298,299,300,28,130,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,26,334,335,336,337],"Post-Acute COVID-19 Syndrome","ME\u002FCFS","Rheumatic Arthritis","Juvenile Rheumatoid Arthritis (JRA)","Autoimmune Encephalitis","Celiac Disease","Celiac Disease in Children","Chronic Lyme Disease","Post-treatment Lyme Disease Syndrome","Crohn's Disease","Dysautonomia","Anorexia Nervosa","Bulimia Nervosa","ARFID","Avoidant \u002F Restrictive Food Intake Disorder","Ehlers Danlos Syndrome","Endometriosis","Fibromyalgia (FM)","Long COVID","Lupus","Migraines","Mast Cell Activation Syndrome","Multiple Sclerosis","Myalgic Encephalomyelitis (ME)","Myasthenia Gravis, Generalized","Myasthenia Gravis in Children","Narcolepsy","Obsessive Compulsive Disorder (OCD)","PANDAS","Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)","POTS - Postural Orthostatic Tachycardia Syndrome","General Anxiety Disorder, Social Anxiety Disorder","PTSD - Post Traumatic Stress Disorder","Psoriasis","Traumatic Brain Injury","Tourette's Syndrome","Inflammatory Bowel Disease (IBD)","Neurological Diseases or Conditions","Psychiatric Disorder","Sjogren's Syndrome","Ulcerative Colitis and Crohn's Disease",[315,339,340,341,342,343,344,345,346,347,298,348,349,350,351,352,317,353,354,355,356,357,358,359,360],"Myalgic Encephalomyelitis","Chronic Fatigue Syndrome","Longitudinal Natural History Study","Observational","Neuroinflammatory Disease","Brain inflammation","Neuroinflammatory disorders","PANS\u002FPANDAS","Autoimmune encephalitis","Dysautonomia \u002F POTS","Multiple sclerosis","Autoimmune disease","Inflammatory bowel disease (Crohn's, ulcerative colitis)","Celiac disease","Mood disorders (anxiety, depression, bipolar, PTSD, OCD)","Mobile health app","Patient registry","Wearable devices","Fatigue","Post-exertional malaise","Brain Fog","Mental health","2026-01-20",{"date":363,"type":43},"2026-01-22",{"date":365,"type":43},"2023-07-05",{"date":367,"type":20},"2030-12-31",{"name":369,"class":86},"Brain Inflammation Collaborative",{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":388,"locationsCount":144},"100615873","physician--vs-questionnaire-based-screening-for-psoriatic-arthritis-in-psoriasis-100615873","NCT07298265","Physician- vs Questionnaire-Based Screening for Psoriatic Arthritis in Psoriasis","Comparison of a Physician-Based Versus Questionnaire-Based Approach to Identify Patients With a High Probability of Psoriatic Arthritis Among Patients With Psoriasis: A Prospective Multicenter Study","COMPOSITION","Inclusion Criteria:\n\n1. Age \\>= 18 years.\n2. Definite diagnosis of psoriasis.\n3. Written informed consent.\n\nExclusion Criteria:\n\n1. Unable or unwilling to give informed consent or to comply with the protocol.\n2. Previously assessed by a rheumatologist for the presence of PsA, unless new musculoskeletal symptoms have emerged subsequent to the prior evaluation.",{"count":379,"type":20},500,"Early diagnosis of psoriatic arthritis (PsA) requires close collaboration between dermatologists (as the skin manifestations of psoriatic disease in most cases precede the musculoskeletal manifestations) and rheumatologists (who are usually responsible for the final diagnosis of PsA and treatment of the musculoskeletal manifestations). Previous epidemiological studies suggest that there may still be a significant proportion of undiagnosed PsA patients among those with psoriasis seen by a dermatologist. At the same time, a diagnostic delay of more than 6 months contributes to poor radiological and functional outcomes in PsA patients. Several screening tools \u002F questionnaires (including the Psoriatic Arthritis Screening Evaluation - PASE, the Toronto Psoriatic Arthritis Screen - ToPAS and its further development - TOPAS 2, the Psoriasis Epidemiology Screening Tool - PEST, and the Early Psoriatic Arthritis Screening Questionnaire - EARP) have been developed and validated in the past decades - all relying mostly on symptoms reported by a patient with psoriasis without an evaluation \u002F confirmation of the presence of musculoskeletal symptoms by a dermatologist. The CONTEST study, which compared three screening tools (PASE, ToPAS and PEST) in a secondary care setting, determined that they all had a good probability of detecting PsA (sensitivity of approximately 80%) but had poor specificity (approximately 35%). Further analysis of the results of the above study has identified the most discriminative questions from each of the three questionnaires, including questions about the back and neck, and these items have been combined to create a new single 8-item screening questionnaire (CONTEST). However, a subsequent study demonstrated a similar performance for the CONTEST and the PEST tools. This poor specificity means that screening questionnaires are often not used in practice and raises a risk of overwhelming rheumatology referrals. In a recent survey of GRAPPA members, most of the participants (consisting of dermatologists, rheumatologists, and patient research partners), suggested that a basic evaluation of MSK symptoms by a dermatologist in addition to the patient-reported symptoms (questionnaire) should be part of the screening \u002F referral process. We hypothesize, therefore, that adding a MSK evaluation by dermatologist in the screening process will be able to improve the outcome of the screening and referral process in relation to the PsA detection. In this study, we plan to evaluate the performance of a physician (dermatologist)-based screening and referral strategy as compared to the strategy based on a questionnaire completed by a patient for the detection of patients with a high probability of a diagnosis of PsA among patients with psoriasis. The primary endpoint will be the proportion of patients diagnosed with PsA among patients with psoriasis referred to a rheumatologist. This will be evaluated in the following groups: 1) PEST-positive and dermatologist-negative patients 2) PEST-positive and dermatologist-positive patients 3) PEST-negative and dermatologist-positive patients 4) PEST-negative and dermatologist-negative patients The primary comparison of the proportions of patients diagnosed with PsA (Fisher's exact test) will be done between the dermatologist-negative vs. positive patients among PEST-positive ones (group 1 vs. group 2).",[29,28],"2025-12-17",{"date":384,"type":43},"2025-12-23",{"date":386,"type":43},"2025-09-22",{"date":141,"type":20},{"name":389,"class":86},"Charite University, Berlin, Germany",{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":21,"phases":399,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":144},"100564363","phase-1-safety-and-pharmacokinetics-of-lpx-ti641-in-rheumatoid-arthritis-and-psoriatic-arthritis-100564363","NCT06628206","Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis","Phase 1b Randomized, Double Blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LPX-TI641 in Patients With Rheumatoid Arthritis and Psoriatic Arthritis","Inclusion Criteria:\n\n1. Subject has signed an Informed Consent Form (ICF) prior to any study-specific procedures being performed\n2. ≥ 18 years old, irrespective of their race and ethnicity.\n3. Body Mass Index (BMI) 18.0-35.0 kg\u002Fm2, inclusive, at screening.\n4. Participants are willing and able to adhere to study protocol requirements including but not limited to scheduled outpatient visits, inpatient hospital stay, laboratory tests, and 12-lead ECGs.\n5. A. Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA at least 3 months prior to screening AND Active disease defined by ≥ 6 tender out of 68 joints and ≥ 6 swollen out of 66 swollen joint count at both screening and Day 1.\n\n   AND Participants received conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy for ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The csDMARD allowed include methotrexate (MTX) (≤ 25mg\u002Fweek), sulfasalazine (3 grams a day), hydroxychloroquine (≤400mg\u002Fday), chloroquine (≤250mg\u002Fday), and leflunomide (≤ 20mg\u002Fday) or intolerance to csDMARD as assessed by the investigator OR B. PsA diagnosis of at least 3 months duration prior to the date of first screening with Classification of Psoriatic Arthritis (CASPAR) confirmed diagnosis at Screening. Have active psoriasis defined by at least 1 psoriasis lesion \\>= 2 cm diameter in areas other than the axilla or groin.\n\n   AND Active disease defined by ≥ 3 tender out of 68 joints and ≥ 3 swollen out of 66 swollen joint count at both screening and Day 1.\n\n   AND Participants received standard doses of NSAIDS for ≥4 weeks or csDMARDS (MTX ≤ 25mg\u002Fweek), sulfasalazine (3 grams a day), and leflunomide (≤ 20mg\u002Fday), administered for ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug or intolerance to NSAIDS or DMARDs as assessed by the investigator. Other traditional DMARDS not listed as a prohibited concomitant medication may be considered after discussion with the Study physician.\n6. The subject must be judged to be in good health by the investigator to participate in the study, based on clinical evaluations, including laboratory safety tests, medical history, physical examination, vital signs and 12-lead ECG competed at the screening visit and prior to the first dose of study drug.\n7. Female subject is postmenopausal (at least 1 year; to be confirmed by follicle stimulating hormone (FSH) if less than 2 years since last menstrual period), permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy or if of childbearing potential and engaged in sexual activity that can result in pregnancy must agree to use any two of the highly effective contraception methods listed below. Male participants with a partner of childbearing potential must also agree to use any two of the highly effective contraception methods listed below between the both of them. This criterion must be followed from screening visit to 6 weeks after the last dose in females and for 90 days after the last dose for males.\n\n   a. The following applies to all female participants with childbearing potential and female partners of male volunteers enrolled in the study.\n\n   i. Implantable progestogen-only hormone contraception associated with inhibition of ovulation.\n\n   ii. Intrauterine device. iii. Intrauterine hormone-releasing system. iv. Bilateral tubal occlusion. v. Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:\n   1. Oral\n   2. Intravaginal\n   3. Transdermal\n   4. Injectable vi. Progestogen-only hormone contraception (oral or injectable) is associated with inhibition of ovulation.\n\n   vii. Vasectomized partner viii. Sexual abstinence -this is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated about the duration of the study and the preferred and usual lifestyle of the participant.\n\n   ix. A combination of male condoms with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods) b. The following applies to all male participants in the study: i. Sexual abstinence- this is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence must be evaluated for the study and the participant\\'s preferred and usual lifestyle.\n\n   ii. A combination of male condoms with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods).\n\n   iii. Vasectomy\n8. Negative serum B-human chorionic gonadotropin test at screening (for all females) and negative urine pregnancy at randomization (Day 1) (females of childbearing potential) prior to administration of investigational product.\n\nExclusion Criteria:\n\n* Any subject who meets any of the following criteria will not qualify for entry into the study:\n\n  1. History of clinically significant medical conditions or any other reason that in the opinion of the PI would interfere with subject's participation in this study\n  2. History of clinically significant per the PI's opinion drug or alcohol abuse within the last 6 months\n  3. Pregnant or lactating women or women currently undergoing infertility treatments or women who intend to become pregnant during the time of study enrollment.\n  4. Any known history of malignancy within 5 years other than other than completely treated non-metastatic basal cell carcinomas or squamous cell carcinomas of the skin or localized carcinoma in situ of the cervix.\n  5. Any known history of a rheumatologic, autoimmune or cutaneous disease other than RA (except secondary Sjögren\\'s syndrome), or PSA.\n  6. Significant systemic involvement secondary to RA\u002FPsA (active vasculitis, pulmonary fibrosis, or Felty\\'s syndrome).\n  7. Currently have non-plaque forms of psoriasis e.g. erythrodermic, guttate or pustular with the exception of nail psoriasis which is allowed.\n  8. Receipt of an investigational therapy less than 3 months or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study\n  9. Receipt of any of the following excluded therapies:\n\n     Any cell depleting therapy including but limited to anti-CD4, anti-CD5, anti-CD3, rituximab, ocrelizumab, or ofatumumab.\n\n     Have received prior tsDMARDs including but not limited to inhibitors of Janus kinase (JAK), Bruton tyrosine kinase, or tyrosine kinase 2, including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib.\n\n     Have received prior immunomodulatory bDMARDs including, but not limited to adalimumab, golimumab, ustekinumab, secukinumab, tocilizumab, abatacept, belimumab, anifrolumab or other inhibitors of TNF, IL-6, IL-23, or IL-17 Receipt of any other conventional DMARDs (not allowed per inclusion criteria 3) within less than 5 half-lives, prior to screening visit.\n  10. Lack of response to \\> 1 therapeutic agent targeting tumor necrosis factor.\n  11. If on prednisone, subject must be on stable dose, not to exceed equivalent of 10mg of prednisone per day (RA and PsA), and dose must be stable for ≥ 4 weeks prior to Day 1. No injected corticosteroids 8 weeks prior to first dose of study drug (e.g intraarticular, intramuscular, or intravenous)\n  12. Use of psoriasis treatments:\n\n      1. Oral or topical retinoids 2 weeks prior to Day 1 and throughout the study\n      2. Topical treatments (steroids, or JAK inhibitors) within 2 weeks prior to Day 1 and throughout the study\n      3. PUVA or UVB phototherapy within 4 weeks prior to Day 1 and throughout the study.\n  13. No high potency opioid analgesics 2 weeks prior to baseline and during study. Analgesic dose must remain stable throughout from screening through completion of the study.\n  14. COVID-19:\n\n      The subject has COVID-19 positive status (confirmed by clinical signs and symptoms and a positive SARS-CoV-2 NAAT or rapid antigen COVID test) at any time during the screening period.\n\n      OR has had recent COVID-19 vaccination including a booster dose in the past 30 days prior to screening OR has received anti-viral therapy intended to prevent COVID-19 such as nirmatrelvir\u002Fritonavir, remdesivir, molnupiravir, interferons, anti-SARS-CoV-2 monoclonal antibodies, IVIG SARS-CoV-2, COVID-19 convalescent plasma, etc. within the past 30 days prior to screening\n  15. Subject has clinical or laboratory evidence of active or latent tuberculosis (TB) infection at screening as assessed by QuantiFERON-TB-Gold or a purified protein derivative skin test or equivalent (or both if required per local guidelines) and chest X-ray. Chest X-rays taken within 2 months prior to screening may be used instead of during screening if there is documentation showing no evidence of infection or malignancy as read by qualified physician.\n  16. Any active or recurrent infection within the past 4 weeks prior to screening requiring IV or oral antibiotics.\n  17. Laboratory values of the following at the Screening Visit:\n\n      Hemoglobin \\< 9 g\u002FdL for males and \\< 8.5 g\u002FdL for females WBC \\<3.5X109\u002FL; Absolute neutrophil count (ANC) \\< 1500 cells\u002FµL, (or \\< 1200 cells\u002FµL for Black participants of African descent) Aspartate aminotransferase or alanine aminotransferase \\> 2.0 x the upper limit of normal (ULN) or bilirubin \\>= ULN; Bilirubin \\>ULN Serum creatinine \\> 1.5 x the ULN; Platelets \\< 100,000 cells\u002F\\[mm\\^3\\] (10\\^9\u002FL); Clinically significant abnormal screening laboratory results as evaluated by the Investigator\n  18. Acutely worsened renal function within past 3 months prior to screening or estimated creatinine clearance \\<60ml\u002Fmin by CKD-EPI creatinine equation\n  19. Participants with a history of active or latent TB will be excluded from the study, unless documentation of complete TB treatment, consistent with local country guidelines, can be provided.\n  20. Subject has any clinically significant finding on 12-lead ECG at screening or admission. NOTE: QTc(F) interval of \\>450 msec in male participants or \\>470 msec in female participants will be the basis for exclusion from the study. ECG may be repeated once for confirmatory purposes if initial values obtained exceed the limits specified.\n  21. Subject with positive results for HBsAg (hepatitis B surface antigens) and\u002For HBcAb (Hepatitis B core antibodies) and\u002For HCV Ab (hepatitis C antibodies), and\u002For HIV Ab (human immunodeficiency virus antibodies).\n  22. Blood loss of \\>250 mL or donated blood within 56 days or donated plasma within 7 days of screening.\n  23. Recent vaccination with live attenuated vaccines such as influenza, measles, mumps, and rubella (MMR), Herpes zoster, varicella, yellow fever, Rotavirus vaccine, etc., or inactivated vaccines such as Hepatitis A, rabies vaccine, etc. in the past 30 days.\n  24. History of infection 1) requiring hospitalization or parenteral antimicrobial therapy within 3 months prior to Day 1 or 2) treated with oral antimicrobial therapy within 2 weeks prior to Day 1.\n  25. Subject is investigative site personnel, sponsor personnel, or a member of their immediate families (spouse, parent, child or sibling whether biological or legally adopted).",{"count":398,"type":20},48,[23],"The goal of this clinical trial is to study the drug LPX-TI641 in patients with rheumatoid arthritis and psoriatic arthritis. We will compare the safety and tolerability of LPX-TI641 to placebo that contains no drug. We will also evaluate the plasma pharmacokinetics of LPX-TI641. LPX-TI641 (or placebo) will be administered orally for 28 days.",[27,28],[403,404,405],"Phase 1 study","pharmacokinetics","safety","2025-11-17",{"date":408,"type":43},"2025-11-20",{"date":410,"type":43},"2024-12-15",{"date":412,"type":20},"2026-01-15",{"name":414,"class":50},"LAPIX Therapeutics Inc.",{"id":416,"slug":417,"hasResults":11,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":180,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":423,"conditions":424,"keywords":432,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":439,"leadSponsor":441,"locationsCount":4},"100607417","mass-spectrometry-based-immune-profiling-in-autoimmune-diseases-100607417","NCT07188285","Mass Spectrometry-based Immune Profiling in Autoimmune Diseases","Mass Spectrometry-based Immune Profiling in Peripheral Blood of Autoimmune Diseases","Inclusion Criteria:\n\n1. Male or female, and aged 18-70 at the time of screening interview (inclusive).\n2. The diagnosis of each disease meets the following standards - Systemic lupus erythematosus: 1997 ACR lupus classification standard\n\n   * Behcet's disease: 2014 ICBD Behcet's disease classification standard\n   * ANCA-associated vasculitis: 1990 American College of Rheumatology Classification Standard\n   * Rheumatoid arthritis: 1987 ARA classification standard\n   * Ankylosing spondylitis: new york standard revised in 1984\n   * Sjogren's syndrome: 2016 ACR\u002FEULAR Sjogren's syndrome classification standard\n   * Inflammatory myopathy: Bohan recommended criteria in 1977\n   * Systemic sclerosis: SSc standard formulated by American Rheumatology Association in 1980.\n   * Psoriatic arthritis: CASPAR standard in 2006\n   * Gouty arthritis: 1997 ACR gout classification standard\n3. Disease activity status, each disease should meet the disease activity index;\n4. Glucocorticoid (≤1mg\u002Fkg\u002Fd prednisone or other hormones with equivalent dose) was used before joining the group, and DMARDs (such as methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil, leflunomide, cyclosporine, etc.) were allowed;\n5. When participating in the trial, the patient must be informed in writing and hope that the patient can abide by the requirements of the research follow-up plan and other protocols.\n\n   Exclusion Criteria:\n\n1\\. Use IVIg or cyclophosphamide within 1.2 months, use other biological agents (infliximab, adalimumab, etanercept, anakinra, etc.) within 3 months, and use rituximab within 6 months; 2.1 months after receiving high-dose glucocorticoid (\\> 1 mg\u002Fkg\u002Fd). 3. Serious complications: including heart failure (≥ NYHA III), renal insufficiency (creatinine clearance rate ≤30 ml\u002Fmin) and hepatic insufficiency (serum ALT or AST is greater than three times the normal upper limit, or total bilirubin is greater than the normal upper limit).\n\n4\\. Other serious, progressive or uncontrollable hematological, gastrointestinal, endocrine, lung, heart, nerve or brain diseases (including demyelinating diseases, such as multiple sclerosis).\n\n5\\. Suffering from serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or being hospitalized due to infection, or using intravenous antibiotics to treat infection 2 months before the first dose of treatment.\n\n6\\. Chest imaging showed abnormalities of malignant tumor or current active infection (including tuberculosis) within 3 months before enrollment.\n\n7\\. Infected with HIV(HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If the serum is positive, it is recommended to consult a doctor with expertise in treating HIV or hepatitis C virus infection.\n\n8\\. Any known malignant tumor or history of malignant tumor in the past 5 years. 9. Received any vaccination within 3 months before joining the group.",{"count":379,"type":20},"Based on mass spectrometry flow method, this study analyzed the typing of new T, B, NK and DC cell subsets in peripheral blood of common autoimmune diseases and their correlation with disease activity, aiming at establishing an early screening and diagnosis model of autoimmune diseases.",[425,336,426,190,427,27,428,429,430,28,431],"Systemic Lupus Erthematosus","Inflammatory Myopathies","Vasculitis","Ankylosing Spondylitis","Osteoarthritis","Gouty Arthritis (GA)","Healthy Controls",[433,434],"autoimmune diseases","mass spectrometry","2025-09-16",{"date":437,"type":43},"2025-09-23",{"date":435,"type":20},{"date":440,"type":20},"2026-09-30",{"name":442,"class":86},"Peking University People's Hospital",{"id":444,"slug":445,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":16,"minAge":451,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":21,"phases":453,"briefSummary":454,"conditions":455,"keywords":457,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":469},"100605262","phase-4-redo-jak-dose-reduction-of-janus-kinase-inhibitors-in-patients-with-inflammatory-rheumatic-diseases-100605262","NCT07160231","REDO-JAK: Dose Reduction of Janus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases","REDO-JAK: Dose REDuction Of JAnus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases","REDO-JAK","Inclusion Criteria:\n\n* Patients ≥ 16 years of age\n* Clinical diagnosis of RA, PsA or axSpA\n* Treated with a JAKi (monotherapy or combination with csDMARDwith a JAKi dose ≥ 50% of the authorised dose)\n* LDA or remission for at least 6 months according to accepted criteria for the specific disease and\u002For the judgement of the treating rheumatologist and patient. (RA: DAS28-CRP \\\u003C 2.9; PsA: PASDAS ≤3.2 and psoriasis mBSA involvement ≤3%; axSpA: ASDAS \\\u003C2.1.)\n\nExclusion Criteria:\n\n* Comorbidity for which continued JAKi treatment is expected to be necessary (e.g. active Crohn's disease, ulcerative colitis)\n* Life expectancy ≤12 months\n* Pregnancy (JAKi are contra-indicated during pregnancy, therefore we do not expect patients using a JAKi while pregnant)\n* Patients who are enrolled in other trials that might mutually interfere\n* Not able to provide informed consent","16 Years",{"count":125,"type":20},[64],"The goal of this clinical trial is to assess the effectiveness of a disease activity guided dose reduction strategy of Janus kinase inhibitor (JAKi) compared to disease activity guided JAKi continuation in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) who are in a state of low disease activity or remission while on JAKi. The main question it aims to answer is:\n\nIs a disease activity guided dose reduction strategy for JAKi not inferior in terms of efficacy compared to disease activity guided JAKi continuation in patients with RA\u002FPsA\u002FaxSpA that are currently in a low disease activity\u002Fremission state?\n\nResearchers will compare a disease activity guided dose reduction strategy for JAKi to disease activity guided JAKi continuation in patients with RA\u002FPsA\u002FaxSpA that are currently in a low disease activity\u002Fremission state to see if a disease activity guided dose reduction strategy for JAKi is not inferior in terms of efficacy compared to disease activity guided JAKi continuation.\n\nParticipants will:\n\n* Follow a JAKi dose reduction strategy or will continue using JAKi in the same dose\n* Study (telemonitoring) visits are planned every 3 months\n* At every visit, patients are asked to complete patient-reported outcomes that assess daily functioning, health-related quality of life, pain, fatigue, productivity loss, medical consumption and medication adherence.",[27,28,456],"Axial Spondyloarthritis (AxSpA)",[458,459,460],"disease activity guided dose reduction","Janus kinase inhibitors (JAKi)","disease activity guided JAKi continuation",{"date":462,"type":43},"2025-09-17",{"date":464,"type":43},"2025-09-15",{"date":466,"type":20},"2028-05-01",{"name":468,"class":86},"Sint Maartenskliniek",7,{"id":471,"slug":472,"hasResults":11,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":144},"100605730","treatment-effectiveness-in-people-with-axspa-or-psa-starting-treatment-with-bimekizumab-risankizumab-guselkumab-upadacitinib-or-a-tnf-inhibitor-100605730","NCT07166315","Treatment Effectiveness in People With axSpA or PsA Starting Treatment With Bimekizumab, Risankizumab, Guselkumab, Upadacitinib, or a TNF Inhibitor","Clinical Characteristics, Treatment Patterns and Outcomes in Patients With axSpA and PsA Following Initiation of Bimekizumab, Risankizumab, Guselkumab, Upadacitinib or a TNF Inhibitor","Inclusion Criteria:\n\n* Participant has a clinical diagnosis of axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA).\n* Participant has been prescribed advanced therapy within one month prior to enrolment in the study, to treat their axSpA or PsA.\n* Participant is aged 18 years or older at enrolment.\n\nExclusion Criteria:\n\n-Participation in a clinical trial at enrolment.",{"count":478,"type":20},700,"This observational study will target patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) who have started treatment with bimekizumab, upadacitinib, risankizumab, guselkumab, or a tumour necrosis factor-alpha inhibitor (e.g., adalimumab or etanercept) at NHS hospitals in the United Kingdom. Information from patients' medical records will be collected, and patients will complete surveys about their experiences with their treatment. The study will look at treatment effectiveness from both healthcare professionals' and patients' points of view.",[481,28],"Axial Spondylarthritis (axSpA)","2025-09-09",{"date":484,"type":43},"2025-09-10",{"date":486,"type":43},"2025-07-07",{"date":488,"type":20},"2027-03",{"name":490,"class":50},"Adelphi Real World",{"id":492,"slug":493,"hasResults":11,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":180,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":144},"100604475","clinical-assessment-for-rheumatologic-disease---research-and-advancement-in-safety-and-efficacy-100604475","NCT07150000","Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE","Inclusion Criteria:\n\n* Participants aged ≥ 18 years\n* Signed written informed consent to participate voluntarily in the study.\n* Confirmed diagnosis (by the treating physician) of one of the following autoimmune or autoinflammatory rheumatic diseases:\n* Rheumatoid arthritis (RA)\n* Psoriatic arthritis (PsA)\n* Axial spondyloarthritis (axSpA)\n* Giant cell arteritis (GCA)\n* Connective tissue diseases, including:\n\n  1. Systemic lupus erythematosus (SLE)\n  2. Systemic sclerosis (SSc)\n  3. Mixed connective tissue disease (MCTD)\n  4. Idiopathic inflammatory myopathies (IIM)\n* ANCA-associated vasculitides (AAV), including:\n\n  1. Microscopic polyangiitis (MPA)\n  2. Granulomatosis with polyangiitis (GPA)\n  3. Eosinophilic granulomatosis with polyangiitis (EGPA)\n* Autoinflammatory diseases, including\n\n  1. Familial Mediterranean fever (FMF)\n  2. Cryopyrin-associated periodic syndromes (CAPS)\n  3. TNF receptor-associated periodic syndrome (TRAPS)\n  4. Adult-onset Still's disease (AOSD)\n\n     Exclusion Criteria:\n* Refusal to participate in the study or inability to provide informed consent.\n\nInclusion Criteria - Healthy Control Group:\n\n* Participants aged ≥ 18 years (capable of providing informed consent).\n* Signed written informed consent to participate voluntarily in the study.\n\nExclusion Criteria - Healthy Control Group:\n\n\\- Presence of a known or active rheumatologic disease.",{"count":500,"type":20},120,"The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases. The primary objective is the development and implementation of an innovative cell-based ex vivo assay that enables individualized prediction of therapeutic response to disease-modifying antirheumatic drugs (DMARDs). By identifying the most effective treatment option for each patient, this approach seeks to enhance therapeutic efficacy, reduce time to clinical response, and minimize healthcare costs.\n\nDespite the availability of numerous DMARDs, clinical decision-making remains largely empirical due to considerable interindividual variability in treatment response. This frequently results in a prolonged trial-and-error process, placing a significant burden on patients and the healthcare system. CARe RAiSE aims to overcome this limitation by providing a functional diagnostic tool that can predict a patient's immunological response to specific DMARDs prior to treatment initiation.\n\nThe assay is based on peripheral blood mononuclear cells (PBMCs) obtained from individual patients, enabling a physiologically relevant assessment of immune responsiveness to targeted therapies. Combining high-content imaging with homogeneous well-based cytokine and inflammasome activity assays, the platform allows for a detailed single-cell analysis of inflammatory pathways. These data are used to generate predictive signatures of treatment response, thereby facilitating a mechanistically informed and personalized therapeutic strategy.\n\nThrough this approach, CARe RAiSE introduces a scientifically grounded, efficient, and patient-specific method for DMARD selection, with the potential to substantially improve patient outcomes and reduce the socioeconomic impact of autoimmune rheumatic diseases.",[503,27,504,28,481,505,506,507,190,508,509,510,511],"Rheumatic Diseases","Giant Cell Arteritis (GCA)","Polymyalgia Rheumatica (PMR)","ANCA Associated Vasculitis (AAV)","Connective Tissue Disease (CTD)","Systemic Lupus Erthematosus (SLE)","Idiopathic Inflammatory Myopathy (IIM)","Autoinflammatory Disease","Gout Arthritis","2025-08-24",{"date":514,"type":43},"2025-09-02",{"date":516,"type":43},"2025-04-01",{"date":518,"type":20},"2028-12",{"name":520,"class":86},"University of Bonn",{"id":522,"slug":523,"hasResults":11,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":21,"phases":531,"briefSummary":532,"conditions":533,"keywords":536,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":51},"100567304","comfi---a-combined-fatigue-intervention-100567304","NCT06666452","COMFI - a COMbined Fatigue Intervention","The Feasibility Test of a COMbined Fatigue Intervention (COMFI) for People With Inflammatory Athritis","COMFI","Inclusion Criteria:\n\n1. Current fatigue level (VAS-Fatigue: The VAS-fatigue has to be 60 or above.\n2. Must have experienced fatigue as a challenge for at least the last 3 months\n3. A rheumatologist-confirmed diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Spondyloarthritis\n4. The patient is in a stable phase regarding disease activity. This means no current plans to adjust pharmacological treatment, and no changes in treatment in the last 3 months (DMARDs or steroids) incl. steroid injections.\n5. Must be affiliated with the Danish Hospital of Rheumatic Diseases or Skaane University Hospital in Lund.\n6. Age ≥18 years.\n7. Must be able to speak and write Danish or Swedish well enough to participate in group discussions without an interpreter.\n8. The participant must be interested in actively participating and making changes to daily life to improve their condition.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding\n2. Critical\u002Fserious illness:\n\n   * Diseases with an expected survival of \\\u003C 2 years (e.g., cancer)\n   * Heart failure with NYHA class 3 or 4\n   * Kidney failure with eGFR \\\u003C 30\n   * Severe anemia - hemoglobin ≤ 5.0 mmol\u002FL\n3. Clarification of known diseases, which must be well-treated or in remission:\n\n   * Diabetes: HbA1c \\>53 mmol\u002Fmol is excluded if dysregulated\n   * Thyroid disease: TSH: 0.4-4.0 mE\u002FL. Excluded if dysregulated\n4. A medical condition that would make the proposed interventions unsuitable\u002Fimpossible for group participation or hinder the ability to give informed consent:\n\n   * Unstable psychiatric illness\n   * Dementia or other severe cognitive problems\n   * Hearing loss\u002Fuse of hearing aids (it must be clarified how the person feels about being in a group setting)\n   * Other physical or mental conditions with the above effect\n5. Conditions that may be the primary cause of fatigue:\n\n   * Long-term effects after COVID-19\n   * Chronic fatigue syndrome\n6. Participation in another research project that could affect fatigue (WORK-ON, INSELMA, SPINCODE)\n7. Participation in the fatigue program for hospitalized patients or support in another way specifically related to fatigue\n8. The participant must not have a planned rehabilitation stay (e.g., Danish Rheumatism Hospital, Sano, Montebello) or another program elsewhere that works with fatigue\n9. If the participant cannot commit to attending on the scheduled dates in one of the two programs.",{"count":530,"type":20},40,[98],"Background: Inflammatory arthritis (IA) encompasses autoimmune rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Fatigue is highly prevalent in people with IA with 41-57% suffering from severe fatigue. Patients describe fatigue as overwhelming, unpredictable, challenging to manage, and affecting all areas of everyday life, including the ability to work. Studies have shown that interventions with physical activity or a cognitive behavioral approach can significantly reduce fatigue severity and\u002For impact in people with IA compared to usual care. To date, no studies have investigated the combined effect of CBA and PA on fatigue severity and impact in patients with IA. Therefore, the goal of this study is to test the feasibility of a newly developed fatigue intervention that combines a cognitive behavioral approach and physical activity (COMFI) in patients with inflammatory arthritis, who experience fatigue as a challenge in their everyday lives in Denmark and Sweden. The intervention will be tested in 4 groups (2 in Denmark and 2 in Sweden), and the participants will participate in 7 group sessions and 2 focusgroups interview in the evaluation.\n\nThe primary outcome for the participants is fatigue, measured through patient-reported outcomes at baseline, 3, 6, and 12 months after baseline.\n\nThis study will show if the intervention is feasible in practice and meaningful for the participants.",[27,28,534,535],"Spondyloarthritis (SpA)","Inflammatory Arthritis",[357,537,538,539],"Intervention","cognitive behavioural approach","Physical activity","2025-08-14",{"date":542,"type":43},"2025-08-15",{"date":544,"type":43},"2024-10-01",{"date":546,"type":20},"2026-04",{"name":548,"class":86},"The Danish Center for Expertise in Rheumatology",{"id":550,"slug":551,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":21,"phases":557,"briefSummary":558,"conditions":559,"keywords":560,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":144},"100601515","phase-4-impact-of-glucagon-like-peptide-1-glp-1-analogs-on-disease-outcomes-in-psoriatic-arthritis-a-pragmatic-randomized-controlled-trial-100601515","NCT07111494","Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patients (age 18 and older) who present to rheumatology clinic\n* Participants must be able to read, understand, and provide documented informed consent as approved by the Institutional Review Board (IRB).\n* Meet the Classification of Psoriatic Arthritis (CASPAR) criteria for PsA\n* Participants must have a Body Mass Index (BMI) of 30kg\u002Fm\\^2\n* Participants must be treated for PsA in accordance with guidelines\n* Have not achieved MDA in PsA patients\n* Have a minimum TJC \\> 1 and SJC \\> at baseline\n* Eligible for GLP-1 agonist treatment in accordance with Food Drug Administration (FDA) labeling as determined by the investigator.\n\nExclusion Criteria:\n\n* Any prior use of GLP-1 agonists\n* Inability to provide informed consent\n* Current participation in another PsA study\n* Treatment initiation by GLP-1 agonists contraindicated by FDA\n* Patients with hemoglobin A1c (HbA1c) \\> 10 at baseline",{"count":556,"type":20},22,[64],"Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects the joints but can also have an effect on multiple parts of the body. This study will assess if the effectiveness of Glucagon-like peptide-1 (GLP-1) medications used to treat type 2-diabetes and weight management, or nutrition counseling can better treat individuals with Psoriatic Arthritis who are also needing treatment for obesity and type 2 diabetes.\n\nThe main objectives it aims to answer are:\n\nTo assess disease outcomes of PsA patients undergoing treatment for concomitant obesity and type 2 diabetes with GLP-1 analogs vs nutrition counseling.\n\nTo assess effectiveness as measured by clinical and patient reported outcome measures in patients treated with GLP-1 and nutrition counseling.\n\nParticipants will be randomized to receive a GLP-1 or nutrition counseling. Participants will be asked to come to the study center at most four times during a 24-week period. During this time participants will be asked to fill out questionnaires, receive a physical exam, and have their blood drawn.",[28],[103,561,562,563],"GLP-1","Minimal Disease Activity","Nutrition Counseling","2025-08-07",{"date":566,"type":43},"2025-08-13",{"date":568,"type":20},"2025-10-15",{"date":570,"type":20},"2028-10-15",{"name":572,"class":86},"Medical College of Wisconsin",{"id":574,"slug":575,"hasResults":11,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":21,"phases":583,"briefSummary":584,"conditions":585,"keywords":587,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":595,"locationsCount":144},"100594692","personalized-outreach-for-equitable-treatment-in-rheumatology-100594692","NCT07022756","Personalized Outreach for Equitable Treatment in Rheumatology","Personalized Outreach for Equitable Treatment in Rheumatology: A Randomized Controlled Trial of Patient Outreach and Honoraria in an Inner City Rheumatology Clinic","POET-Rheum","Inclusion Criteria:\n\n* Have a diagnosis of inflammatory arthritis secondary to an autoimmune rheumatic disease\n* Be attached to one of the Vancouver Coastal Health Community Health Centres for primary care\n* Be willing to attend in-person appointments at Pender Community Health Centre\n* Be at least 18 years of age and capable of consenting to participation\n* Be able to receive medical care in English.\n\nExclusion Criteria:\n\n* Have cognitive impairment or an untreated psychiatric condition that would severely impair ability to engage with outreach or treatment\n* Have no reasonably reliable method of contact (phone, email, social media, etc.)",{"count":582,"type":20},20,[98],"The primary goal of this study is to determine whether providing patient honoraria and\u002For outreach services can improve the attendance rate of appointments at an inner city rheumatology clinic in Vancouver, British Columbia.\n\nThe main question it aims to answer are:\n\n* Does providing a financial honorarium ($20 for each follow-up appointment with completed bloodwork) improve attendance rate at an inner city rheumatology clinic?\n* Does providing a personalized outreach service for rheumatic diseases improve attendance rate at an inner city rheumatology clinic?\n\nThe researchers will compare providing patient honoraria to providing both honoraria and outreach services, and compare each of these to the regular appointment schedule without honoraria or outreach.\n\nParticipants will:\n\n* Undergo randomization to receive honoraria or honoraria and outreach services together\n* Complete surveys about their health and understanding of their rheumatic disease at baseline, 3-month, and 6-month intervals\n* Visit the clinic every month for check-ups and monitoring bloodwork if they are started on immunosuppressants for their condition",[503,535,27,28,586],"Connective Tissue Disease",[201,535,588],"Inner City Health","2025-07-01",{"date":591,"type":43},"2025-07-04",{"date":593,"type":20},"2025-07-02",{"date":45,"type":20},{"name":596,"class":86},"University of British Columbia",{"id":598,"slug":599,"hasResults":11,"nctId":600,"briefTitle":601,"officialTitle":601,"acronym":4,"eligibilityCriteria":602,"healthyVolunteers":180,"sex":16,"minAge":603,"maxAge":60,"enrollmentInfo":604,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":606,"conditions":607,"keywords":4,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":614,"locationsCount":144},"100596503","right-ventricular-strain-in-detecting-subclinical-right-ventricular-systolic-dysfunction-in-psoriatic-arthritis-patients-relation-to-serum-endostatin-level-100596503","NCT07046312","Right Ventricular Strain in Detecting Subclinical Right Ventricular Systolic Dysfunction in Psoriatic Arthritis Patients: Relation to Serum Endostatin Level","Inclusion Criteria:\n\n* Psoriatic arthritis patients according to CASPAR criteria\n* Psoriatic arthritis patients without overt cardiovascular symptoms\n* Patients with age between 20 to 50 years of age\n\nExclusion Criteria:\n\n* Other systemic autoimmune diseases\n* Patients with a history of known valvular disease, atrial fibrillation or any other arrhythmia , heart failure, ischemic cardiomyopathy severe obstructive pulmonary diseases and metabolic syndrome.\n* Patients with medical disorders as renal, congenital heart diseases, hematological disorders and cancer patients.\n* Patients taking certain drugs that have been confirmed to be risk factors for PAH such as appetite suppressant intake drugs (aminorex, fenfluramine derivatives and benfluorex) and chemotherapeutic agents.\n* Family history of myocardial infarction, cerebrovascular disease or sudden death before the age of 65y in females and 55 y in males.","20 Years",{"count":605,"type":20},60,"The aim is to assess early right ventricular systolic dysfunction in psoriatic arthritis patients using RV strain echocardiography",[28,608],"Subclinical Right Ventricular Systolic Dysfunction","2025-06-29",{"date":589,"type":43},{"date":612,"type":20},"2025-07",{"date":282,"type":20},{"name":615,"class":86},"Ain Shams University",{"id":617,"slug":618,"hasResults":11,"nctId":619,"briefTitle":620,"officialTitle":621,"acronym":622,"eligibilityCriteria":623,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":153,"enrollmentInfo":624,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":626,"conditions":627,"keywords":630,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":144},"100586708","comparison-of-liver-health-in-psoriatic-arthritis-patients-using-anti-tnf-or-anti-il17-treatments-100586708","NCT06918886","Comparison of Liver Health in Psoriatic Arthritis Patients Using Anti-TNF or Anti-IL17 Treatments","Evaluation of Liver Fibrosis and Hepatic Steatosis Using FIB-4 Score and Ultrasonography in Psoriatic Arthritis Patients Treated With TNF or IL-17 Inhibitors: A Retrospective Controlled Study","FIB-4 PsA","Inclusion Criteria:\n\n* Age 18 to 65 years\n* Diagnosed with psoriatic arthritis (PsA) according to standard classification criteria\n* Receiving biologic therapy (anti-TNF or anti-IL-17) or MTX monotherapy for ≥2 years\n* Able to provide historical data (medical records) on liver ultrasound and laboratory parameters\n\nExclusion Criteria:\n\n* History of any other chronic liver disease (e.g., viral hepatitis, autoimmune hepatitis)\n* Significant alcohol consumption (\\>20 g\u002Fday women, \\>30 g\u002Fday men)\n* Concomitant use of other hepatotoxic drugs apart from MTX\n* Unwillingness or inability to comply with study assessments",{"count":625,"type":20},90,"Psoriatic arthritis (PsA) is an inflammatory joint disease that can also affect the liver. Some medications used to treat PsA, such as biological agents (TNF-alpha inhibitors and IL-17 inhibitors), may influence liver health over the long term. This retrospective study aims to evaluate the presence and progression of liver fibrosis (scarring) and hepatic steatosis (fatty liver) in PsA patients treated with TNF-alpha inhibitors or IL-17 inhibitors.\n\nThe study includes PsA patients who have used biological medications continuously for at least 2 years. Patients' liver health will be assessed using non-invasive tests such as liver ultrasonography and validated biochemical scoring systems (FIB-4, APRI). The findings will be compared with PsA patients treated only with methotrexate (MTX), a commonly used medication known to affect liver health.\n\nThis study will help understand whether biological therapies (TNF or IL-17 inhibitors) have a positive or negative impact on liver health compared to traditional treatments (MTX) in patients with psoriatic arthritis.",[28,628,629],"Liver Fibrosis","Liver Diseases",[103,628,631,632,633,634,635,636,637,638],"FIB-4 Score","Anti-TNF Therapy","Anti-IL17 Therapy","Biological Therapy","Liver Health","Retrospective Study","Hepatic Safety","Chronic Inflammatory Arthritis","2025-04-07",{"date":641,"type":43},"2025-04-09",{"date":643,"type":20},"2025-04-10",{"date":645,"type":20},"2025-05-01",{"name":647,"class":86},"Bezmialem Vakif University",{"id":649,"slug":650,"hasResults":11,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":180,"sex":656,"minAge":60,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":658,"conditions":659,"keywords":667,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":673,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":144},"100569575","aylo---autoimmunity-and-loss-of-y-100569575","NCT06696027","AYLo - AutoimmunitY and Loss of y","Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases","AYLo","Inclusion Criteria:\n\n* Male\n* \\> 50 years\n* Diagnosis of arthritis (RA, PsA), collagen diseases (SLE, systemic sclerosis, Sjögren's syndrome, mixed connective tissue diseases), vasculitis (eGPA, GPA, MPA, IgG4-related disease, GCA, PMR), sarcoidosis, COPD, ILD or asthma bronchiale confirmed by the treating physician.\n\nExclusion Criteria:\n\n* Female\n* \\\u003C 50 years\n\nInclusion Criteria (Healthy controls):\n\n* Male\n* \\> 50 years\n\nExclusion Criteria (Healthy controls):\n\n* Female\n* \\\u003C 50 years\n* autoimmune, rheumatological diease\n* pulmonary precondition","MALE",{"count":379,"type":20},"The AYLo study (AutoimmunitY and Loss of y - Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases) aims to systematically investigate hematopoietic mutations, such as hematopoietic (mosaic) loss of the Y chromosome (mLOY), focusing on their underlying causes, pathophysiological significance, patterns of manifestation, and impact on disease progression in autoimmune, rheumatologic disorders. This research seeks to bridge existing knowledge gaps by exploring how such mutations influence immune homeostasis, cellular function, and susceptibility to inflammation-driven pathologies.\n\nThrough the integration of advanced immunological profiling, the study aspires to uncover key mechanisms that drive the initiation, progression, and complications of autoimmune rheumatic diseases. These analyses will combine single nucleotide polymorphisms (SNP) arrays, multiplex assays, transcriptomics, and flow cytometry staining of peripheral blood mononuclear cells to delineate the interplay between hematopoietic mutations and immune dysregulation.\n\nA further objective is the development of a multimodal framework for disease-specific characterization, enabling precise mapping of mutation-driven phenotypes across diverse autoimmune conditions. This framework will incorporate clinical, molecular, and imaging data.\n\nAdditionally, the AYLo study aims to explore the potential role of mLOY and other hematopoietic mutations as biomarkers for disease stratification, prognosis, and therapeutic response. The findings may open avenues for personalized treatment approaches, leveraging the molecular insights to inform targeted interventions and improve patient outcomes in autoimmune rheumatic disorders.\n\nBy integrating translational and basic science approaches, this study has the potential to redefine current paradigms in autoimmune disease research and therapy.",[504,505,506,660,661,27,28,586,662,663,664,665,666],"Idiopathic Inflammatory Myopathies","IgG4-Related Diseases","Sarcoidosis","Interstitial Lung Disease Due to Systemic Disease (Disorder)","Interstitial Lung Disease (ILD)","Asthma Bronchiale","COPD",[26,427,668,669,670,671,660,661,37,103,586,662,672],"Large Vessel Vasculitis","Giant Cell Arteritis","Polymyalgia Rheumatica","ANCA Associated Vasculitis","Interstitial Lung Disease",{"date":643,"type":43},{"date":675,"type":43},"2024-11-15",{"date":677,"type":20},"2026-07",{"name":520,"class":86},{"id":680,"slug":681,"hasResults":11,"nctId":682,"briefTitle":683,"officialTitle":684,"acronym":685,"eligibilityCriteria":686,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":687,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":688,"conditions":689,"keywords":4,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":694,"lastUpdatePostDateStruct":695,"startDateStruct":697,"completionDateStruct":699,"leadSponsor":701,"locationsCount":144},"100574997","a-registry-study-assessing-pro-dosing-patterns-and-safety-of-vunakizumab-in-patients-with-general-rheumatic-diseases-100574997","NCT06766552","A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.","A Multicenter Registry Study Assessing Patient Reported Outcome, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.","V-MIRACLE","Inclusion Criteria:\n\n1. Diagnosed with rheumatic autoimmune diseases such as ankylosing spondylitis\u002Fradiologically negative axial spondyloarthritis\u002Fpsoriatic arthritis\u002Fpolymyalgia rheumatica\u002FTakayasu arteritis\u002Fgiant cell arteritis\u002F non-ocular Behcet's disease\u002F enthesitis-related arthritis;\n2. Currently receiving or planning to receive fulvezinib treatment;\n3. Can follow up according to the doctor's advice;\n4. Able to understand and sign the informed consent form, understand the purpose of this study, and voluntarily participate in this study.\n\nExclusion Criteria:\n\n1.Investigator believes will prevent the subject from following and completing the study protocol",{"count":293,"type":20},"Ankylosing spondylitis, radiographically negative axial spondyloarthritis, psoriatic arthritis, polymyalgia rheumatica, Takayasu arteritis, giant cell arteritis, non-ocular Behcet's disease, and enthesitis-related arthritis are common diseases in rheumatology. Traditional anti-rheumatic drugs are less effective and have greater side effects than biological agents. At present, there has been no large-scale registration study on rheumatic autoimmune diseases such as spondyloarthritis in China. However, data such as patient characteristics, medication patterns, and patient outcome reports of different rheumatology diseases can often serve as a reference for rheumatology clinicians to reasonably select treatment methods for different patients. Therefore, a large-scale registration study is needed to fill the gap in multi-disease registration studies in rheumatology departments in China.",[130,28,690,505,691,504,692,693],"Nr-axSpA","Takayasu Arteritis (TAK)","Behcet's Disease","Enthesitis-related Arthritis","2025-01-08",{"date":696,"type":43},"2025-01-09",{"date":698,"type":20},"2025-01-30",{"date":700,"type":20},"2030-06-30",{"name":702,"class":86},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":704,"slug":705,"hasResults":11,"nctId":706,"briefTitle":707,"officialTitle":708,"acronym":709,"eligibilityCriteria":710,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":711,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":713,"conditions":714,"keywords":717,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":726,"lastUpdatePostDateStruct":727,"startDateStruct":729,"completionDateStruct":731,"leadSponsor":733,"locationsCount":735},"100564556","efficacy-of-upadacitinib-in-psoriatic-arthritis-and-comparison-to-rheumatoid-arthritis-100564556","NCT06630715","Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.","Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis. OPTimising IMAging For The Use In The Follow-Up Of Arthritis: The OPTIMA Study","OPTIMA","The inclusion criteria for Psoriatic Arthritis patients are:\n\n1. Patients diagnosed with peripheral Psoriatic Arthritis according to the CASPAR criteria or with axial Psoriatic Arthritis according to ASAS criteria and with at least one of the following:\n\n   1. With active peripheral Psoriatic Arthritis regarding ongoing therapy in one of the following sites: MCP joints 1-5, proximal interphalangeal (PIP) joints of hands 1-5, distal interphalangeal (DIP) joints of hands 2-5, wrists, elbows, knees and ankles\u002Fheels and feet, according to any of the following criteria:\n\n      I) DAPSA ≥ 15 and joint inflammation according to the Global OMERACT-EULAR US scoring for synovitis and power Doppler (GLOESS) with a grade at patient level \\>3,2\n\n      II) With a clinical enthesitis and an active enthesitis (positive power Doppler of any grade), in the clinical symptomatic site, according to the OMERACT US definitions\n\n      III) With active dactylitis (clinical diagnosis made by the physician at the time of baseline visit) and a positive US dactylitis according to the DACTylitis glObal Sonographic (DACTOS) score \\>3\n\n      IV) DAPSA ≥ 15 and tenosynovitis according to the OMERACT US scoring system for tenosynovitis with a grade \\>1\n   2. With active axial PsA regarding ongoing therapy (ASDAS ≥ 2.1) and active sacroiliitis according to the ASAS MRI definitions\n2. Who are eligible according to the current guidelines\u002Fregulations to start treatment with UPA and present a favorable risk\u002Fbenefit profile according to the clinician's opinion for such treatment.\n3. Aged older than 18 years.\n4. Able to provide informed consent, according to requirements of local IRB\u002Fethics committee.\n\nThe inclusion criteria for Rheumatoid Arthritis patients are:\n\n1. Patients diagnosed with RA according to the ACR\u002FEULAR 2010 classification criteria\n2. With active Rheumatoid Arthritis according to the following criteria: DAS28-PCR \\>3.2, and the presence of at least one US finding of the following:\n\n   1. Joint inflammation at hands and wrists according to the Global OMERACT-EULAR (GLOESS) US scoring for synovitis and power Doppler with a grade at patient level \\>2\n   2. One tenosynovitis at hands or wrists, according to the OMERACT US scoring system for tenosynovitis with a grade \\>1\n3. Who are eligible according to the current guidelines\u002Fregulations to start treatment with Upadacitinib and present a favourable risk\u002Fbenefit profile according to the clinician's opinion for such treatment.\n4. Aged older than 18 years.\n5. Able to provide informed consent, according to requirements of local IRB\u002Fethics committee.\n\nExclusion Criteria:\n\n1. Patients with any contraindication to Upadacitinib:\n\n   1. women who are pregnant or breastfeeding\n   2. active infection\n   3. evidence of tuberculosis infection\n   4. known infection with human immunodeficiency virus or hepatitis B or C\n   5. patients who have current malignancy or history of malignancy in the last 5 years\n   6. high cardiovascular risk\n   7. high risk of venous thromboembolism\n   8. patients with severe hepatic impairment\n2. Patients with associated fibromyalgia syndrome according to the 2016 ACR diagnostic criteria\n3. Unable to provide informed consent, according to requirements of local IRB\u002Fethics committee.",{"count":712,"type":20},178,"The general objective of the OPTIMA study is to assess the time course and interrelationship of imaging (ultrasound and magnetic resonance imaging), clinical, laboratory, and Patient Reported Outcome variables in patients with active Psoriatic Arthritis (any subset) and Rheumatoid Arthritis starting therapy with a Jak-Inhibitor (Upadacitinib), during the first 6 months of follow-up.\n\nParticipants will be evaluated at the start of therapy with upadacitinib and during the follow-up visits at 2 weeks, 1, 3, and 6 months post-treatment initiation. At each visit (with the exception of the 2-weeks visit), data relating to the clinical evaluation, laboratory tests, and ultrasound of the affected joints will be collected according to standard clinical practice; questionnaires on disease activity will also be completed. In the case of axial involvement, a magnetic resonance imaging will be performed at baseline and after 6 months of therapy, only if required by the standard of care.",[715,716],"Rheumatoid Arthritis (RA","Psoriatic Arthritis (PsA",[718,103,719,720,721,722,723,724,725],"rheumathoid Arthritis","Ultrasound","MRI","Upadacitinib","Dactylitis","Enthesitis","Synovitis","sacroiliitis","2024-10-04",{"date":728,"type":43},"2024-10-08",{"date":730,"type":43},"2024-07-23",{"date":732,"type":20},"2025-12",{"name":734,"class":86},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio",14]