[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rheumatoid-arthritis-ra\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rheumatoid-arthritis-ra":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,105,0,25,[9,52,84,109,132,169,201,222,251,287,316,343,367,393,415,441,460,486,516,539,572,614,638,663,699],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100629321","phase-1-controlling-hyperactive-immunity-with-long-lived-lymphocytes-100629321",false,"NCT07473154","Controlling Hyperactive Immunity With Long-lived Lymphocytes","Phase I\u002FII Study of QEL-005 in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) and in Patients With Difficult to Treat Rheumatoid Arthritis (D2TRA).","CHILL","Inclusion Criteria:\n\n* Participants must be at least 18 years of age at the time of signing the informed consent.\n* Up to date vaccination status and no planned vaccinations for post 3 months infusion\n* Adequate haematological, liver and renal function\n* Willing to undergo annual influenza vaccination\n* Willing to enter a 15-year follow-up\n* Eastern Cooperative Oncology Group (ECOG) performance status grade \\\u003C 3\n* Able and willing to use a highly effective method of contraception\n* Stable dose of steroid prior to screening\n\nSpecific inclusion criteria for participants with difficult to treat rheumatoid Arthritis (D2TRA) only:\n\n* Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria\n* Diagnosis of D2TRA per 2021 EULAR criteria\n* Evidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA\n* Evidence of inflammation in target joints used for the DAS28 CRP assessment\n\nSpecific inclusion criteria for participants with diffuse cutaneous systemic sclerosis (dcSSc) only:\n\n* Diagnosis of dcSSc as per the 2013 ACR-EULAR criteria\n* Serologically positive for antinuclear antibodies\n* Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs).\n* Skin involvement with a total modified Rodnan Skin Score of at least 15\n* Evidence of lung fibrosis based on imaging or pulmonary function testing\n* Evidence of active disease based on a validated SSc activity assessment\n\nExclusion Criteria:\n\n* Presence of a significant medical condition(s), or clinically significant laboratory abnormality\n* History or concern of autoimmune diseases other than those under study\n* Active infection, or recurrent chronic infection requiring intervention\n* Immunodeficiency or receiving immunoglobulin replacement therapy\n* Past or current infection with hepatitis B or C, tuberculosis, syphilis, or HIV\n* Clinically significant cardiac dysfunction or severe pulmonary impairment\n* Use of investigational agents within a pre-defined period prior to study screening\n* Received a previous cell therapy\n* Received certain B cell related experimental therapies in a clinical trial with the past year\n* Any solid organ, bone marrow or stem cell transplant\n* History of malignancy in the past 5 years\n* Receiving prohibited medication that cannot be stopped at screening","ALL","18 Years",{"count":21,"type":22},16,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This study is a Phase 1\u002F2, open-label clinical trial to test an experimental treatment called QEL-005 in adults with two autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid arthritis (D2TRA). The main goals are to find out whether QEL-005 is safe, how well people tolerate it, and whether it may help reduce disease activity or improve symptoms.\n\nQEL-005 is made from a participant's own white blood cells (autologous cells). These cells are collected and then changed in a laboratory using genetic methods to create specialized immune cells called CAR-T regulatory cells that target a protein on B cells called CD19. These modified cells are then given back to the participant by intravenous (IV) infusion.\n\nTo take part, eligible participants will first have a procedure called leukapheresis, where some of their white blood cells are removed from the blood. The study team will use these cells to manufacture QEL005. After QEL005 is ready, participants will receive an IV infusion of their modified cells, stay in hospital overnight for monitoring, and will then be followed closely in the clinic.\n\nThroughout the trial, participants will have regular safety checks, which may include blood tests, imaging scans, questionnaires about symptoms and daily functioning, and biopsies taken from involved tissues, to help understand how QEL005 is working in the body. Detailed follow up will be for 1 year after QEL-005 infusion, and there is long-term follow up for a total of 15 years, which is standard for cell therapies. The information from this Phase 1\u002F2 study will help determine an appropriate dose and dosing schedule of QEL005 for future studies.",[29,30,31,32],"Diffuse Cutaneous Systemic Sclerosis","Rheumatoid Arthritis (RA)","Systemic Sclerosis (SSc)","Autoimmune Rheumatologic Disease",[34,35,36,37,38],"Regulatory T cells","Autologous","Genetically modified cells","Treg","Chimeric antigen receptor (CAR)","RECRUITING","2026-06-29",{"date":42,"type":43},"2026-06-30","ACTUAL",{"date":45,"type":43},"2026-04-10",{"date":47,"type":22},"2028-08",{"name":49,"class":50},"Quell Therapeutics Limited","INDUSTRY",6,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100645042","medical-device-for-sustained-remission-in-rheumatoid-arthritis-treated-with-biological-therapy-100645042","NCT07678112","Medical Device for Sustained Remission in Rheumatoid Arthritis Treated With Biological Therapy","Efficacy, Safety and Cost-effectiveness of a Biomarker-based Predictive Model for Persistent Remission in Rheumatoid Arthritis Patients Undergoing Biological Therapy Optimization","REMRABIT-Plus","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Diagnosis of rheumatoid arthritis according to either the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR\u002FEULAR classification criteria.\n* Clinical remission for at least 6 months prior to the baseline visit, defined as DAS28-CRP \\\u003C 2.6.\n* Receiving biological anti-TNF therapy (infliximab, adalimumab, etanercept, golimumab, or certolizumab).\n* Ability and willingness to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients in whom biological therapy was prescribed due to systemic manifestations of rheumatoid arthritis.\n* Patients with rheumatoid arthritis and any known associated condition that may interfere with the assessment of study outcomes (e.g., fibromyalgia or concomitant chronic inflammatory diseases).\n* Patients receiving chronic anti-TNF biological therapy who are already undergoing treatment tapering or are on reduced or extended dosing regimens prior to study inclusion.",{"count":61,"type":22},184,[63],"NA","This study aims to evaluate a new tool designed to help doctors decide whether it is safe to reduce medication in patients with rheumatoid arthritis (RA) who are in remission.\n\nRheumatoid arthritis is a chronic inflammatory disease that affects the joints, causing pain, stiffness, and reduced mobility. Many patients receive long-term treatment with biological drugs to control the disease. When the disease is well controlled (remission), doctors may gradually reduce the medication dose. However, deciding when and in whom to reduce treatment is currently based on experience and trial-and-error.\n\nThe study evaluates a predictive tool (called OPTIBIO) that uses information from blood samples, genetic data, and clinical characteristics to estimate the risk that the disease will flare up if treatment is reduced.\n\nParticipants in the study will be randomly assigned to one of two groups:\n\n* In one group, the decision to reduce medication will be made by their usual doctor.\n* In the other group, the decision will be guided by the predictive tool.\n\nThe study lasts 12 months and includes several hospital visits. During these visits, participants will:\n\n* Answer questionnaires about their health and quality of life\n* Have physical examinations\n* Provide blood samples for routine tests and additional research purposes\n* Possibly undergo joint ultrasound (if they consent) Some additional blood samples may be stored in authorized biobanks for future research related to rheumatoid arthritis, but only if participants explicitly agree. These samples will be coded to protect personal identity and will only be used in ethically approved research projects.\n\nParticipation in the study is entirely voluntary. Participants can choose which procedures they agree to and may withdraw at any time without affecting their medical care.\n\nThe study may not provide direct benefit to participants, but it could help improve future treatment decisions and the overall management of rheumatoid arthritis.",[30],[67,68,69,70,71,72],"Rheumatoid arthritis","Treatment Optimization","TNF Inhibitors (TNFi)","Biologic Therapy","Personalized Medicine","Precision Medicine","2026-06-24",{"date":75,"type":43},"2026-07-01",{"date":77,"type":43},"2025-08-28",{"date":79,"type":22},"2027-08",{"name":81,"class":82},"Francisco J. Blanco","OTHER",9,{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":18,"minAge":92,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100644969","phase-1-bioequivalence-study-of-ski-o-703-in-healthy-adults-under-fed-conditions-100644969","NCT07675226","Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions","An Open-label, Randomized, Fed, Single-dose, Oral Administration, 2-treatment, 2-period, Crossover Design, Phase 1 Clinical Trial to Evaluate the Bioequivalence of SKI-O-703 in Healthy Adult Participants","Inclusion Criteria:\n\n1. Korean or Caucasian adults aged 19 years and older at screening. Caucasian: An individual whose parents and grandparents are of European, North American, or Middle Eastern origin; who was born in Europe, North America, or West Asia; and who has resided outside these regions for less than 10 years\n2. Body mass index (weight \\[kg\\] \u002F height2 \\[m\\]2) between 18 and 30 kg\u002Fm2, and body weight not less than 50 kg.\n3. Healthy on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening.\n4. Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, hematology, blood coagulation test, urinalysis or urine drug test are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents.\n5. Must sign voluntarily an informed consent form indicating they understand the purpose of, procedures required for, and comply to the prohibitions and restrictions specified in the study and is willing to participate in the study.\n\nExclusion Criteria:\n\n1. Any significant surgical\u002Fmedical procedure or trauma within 4 weeks before the planned first dose of the study drug or history of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair)\n2. Any current active infections, including localized infections, or any recent history (within 1 week prior to study drug administration) of active infections (including severe acute respiratory syndrome coronavirus 2 \\[SARS-CoV-2\\], cough or fever, or a history of recurrent or chronic infections).\n3. Unable to swallow multiple capsules by mouth.\n4. Received an experimental drug within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled. Prior experience of participating in another clinical trial within 6 months before the planned first dose of the study drug.\n5. Individuals who have dietary habits that may influence the absorption, distribution, metabolism, or excretion of the investigational product or who consume foods known to affect drug metabolism.\n6. Before the start of the study (first day of administration) those who have donated whole blood or blood components within 8 weeks or within 2 weeks, respectively, or received a blood transfusion within 1 month, or cannot refrain from donating blood from the time of written consent until the end of the trial.\n7. History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening.\n8. Individual unable to abstain from alcohol-, caffeine-, or xanthine-containing products within 72 hours before the first dose of study drug and during the study or who tested positive for drug abuse, alcohol at screening or check-in (Day -1).\n\n10\\) Smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarrets, or inhalers) within 30 days before the first dose of study drug or who tested positive for cotinine(indicating active current smoking) at screening or check-in (Day -1) 11) Individuals with hypersensitive to investigational product or components of investigational product 12) A women who are pregnant or suspected of being pregnant or breastfeeding. 13) Participants who do not consent to use medically acceptable methods of contraception\\* to eliminate the possibility of pregnancy from the date of the first dose until 1 month after the last dose of the study drug.\n\n\\*Combined use of an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomized partner, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.), or a combination of at least two barrier methods with spermicide.\n\n14\\) Individuals with hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.",true,"19 Years",{"count":94,"type":22},48,[25],"This is an open-label, randomized, crossover Phase 1 study to evaluate the bioequivalence, pharmacokinetics, and safety of two oral SKI-O-703 drugs (test and reference) in healthy adults under fed conditions. Approximately 48 Korean and Caucasian participants will receive a single oral dose of the test drug and a single oral dose of the reference drug in a randomized sequence, separated by a washout period, with pharmacokinetic sampling and safety assessments performed throughout the study.",[98,99,30],"Bioequivalence Study in Healthy Subjects","Immune Thrombocytopenia (ITP)","NOT_YET_RECRUITING","2026-06-23",{"date":42,"type":43},{"date":104,"type":22},"2026-07-10",{"date":106,"type":22},"2026-12-31",{"name":108,"class":50},"Oscotec Inc.",{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100644741","comparison-of-oral-administration-of-a-jak-inhibitor-in-rheumatoid-arthritis-100644741","NCT07674134","Comparison of Oral Administration of a JAK Inhibitor in Rheumatoid Arthritis","Comparison of Morning Versus Evening Oral Administration of a JAK Inhibitor in Rheumatoid Arthritis","JAK-INHI","Inclusion Criteria:\n\n* Patient aged over 18 years\n* Patient with Rheumatoid Arthritis according to the 2010 ACR\u002FEULAR criteria\n* Patient meeting the criteria for initiation of a JAK inhibitor according to the marketing authorization and international recommendations\n* Patient capable of providing informed, written, dated, and signed consent before the start of any trial-related procedure.\n\nExclusion Criteria:\n\n* No contraindication to a bDMARD\n* Not stable dose of corticosteroids in the 4 weeks preceding enrollment\n* Not stable dose of maintenance therapy (methotrexate, leflunomide, hydroxychloroquine, cyclosporine, gold salts) in the 4 weeks preceding enrollment\n* Prior treatment with a JAK inhibitor\n* Patient unable to be followed-up in the study during 6 months\n* Minors or adults under guardianship or curatorship, or deprived of their liberty\n* Pregnant or breastfeeding patient\n* Patient refusing to use an effective method of contraception for the duration of the study\n* Person not affiliated with a social security scheme.",{"count":118,"type":22},90,"OBSERVATIONAL","The aim of this study is to offer patients two treatment options: morning or evening administration of a JAK inhibitor prescribed within the framework of its marketing authorization, according to the EULAR response.\n\nThe objective is to determine whether evening administration in our patients with rheumatoid arthritis provides greater efficacy than morning administration in our patients taking JAK inhibitors once daily.",[30],[123],"JAK inhibitor",{"date":40,"type":43},{"date":126,"type":43},"2024-04-23",{"date":128,"type":22},"2026-11",{"name":130,"class":82},"Centre Hospitalier Princesse Grace",1,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":142,"conditions":143,"keywords":148,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":131},"100624978","validation-of-hemoglobin-a1c-in-patients-with-inflammatory-arthritis-treated-with-sulfasalazine-100624978","NCT07416656","Validation of Hemoglobin A1c in Patients With Inflammatory Arthritis Treated With Sulfasalazine","How Can We Prevent the Underdiagnosis of Diabetes and the Undertreatment of Known Diabetes in Patients With Inflammatory Arthritis Treated With Sulfasalazine?","DIA2SULFA","Inclusion Criteria:\n\n* Age ≥18 years\n* Treatment with sulfasalazine for at least 2 months prior to inclusion\n* Inflammatory arthritis diagnosis (Reumatoid Arthritis, Reaktive Arthritis, Axial spa, Psoriatic spondylitis, and Juvenil artrit)\n* HbA1c ≥38 mmol\u002Fmol obtained at least 2 months after sulfasalazine initiation OR a diabetes mellitus diagnosis (Type 1 diabetes mellitus, Type 2 diabetes mellitus, Malnutrition-related diabetes mellitus, Other specified diabetes mellitus (andre specificerede former for diabetes), and Unspecified diabetes mellitus (uspecificeret diabetes))\n* Can communicate in Danish\n* Informed consent including permission to upload glucose data and study ID to the Libreview Platform.\n\nExclusion Criteria:\n\n* Systemic treatment or local injections with glucocorticoids within the previous 2 months or planned within the following 4 weeks\n* Clinical conditions interfering with the interpretation of HbA1c expect for sulfasalazine alterations in red cell lifespan (etc. Dapson treatment)\n* Allergy towards the adhesive used in the CGM\n* Considered ineligible for participating (e.g. patients without decision-making capacity, , malignancy, terminal illness, ect.)",{"count":141,"type":22},75,"The purpose of this study is to examine whether the blood test Hemoglobin A1c (HbA1c) gives an accurate picture of blood glucose levels in patients with inflammatory arthritis who are treated with sulfasalazine. HbA1c is widely used to diagnose and monitor diabetes, but sulfasalazine can shorten red blood cell lifespan and thereby lower HbA1c values independently of actual glucose levels.\n\nThis may lead to underdiagnosis of diabetes in patients who develop diabetes during sulfasalazine treatment, and to undertreatment in patients with known diabetes due to falsely reassuring HbA1c values.\n\nThe study aims to answer two main questions:\n\n1. How many patients treated with sulfasalazine have undiagnosed diabetes despite having HbA1c values below the diagnostic threshold?\n2. Does HbA1c underestimate actual glucose levels when compared with continuous glucose monitoring (CGM) in patients with sulfasalazine-treated inflammatory arthritis, both in those with known diabetes and those that are not diagnosed with diabetes but have borderline HbA1c values (≥ 38 mmol\u002Fmol)?",[144,145,30,146,147],"Inflammatory Arthritis","Diabetes (DM)","Type 1 Diabetes Mellitus","Type 2 Diabetes (T2DM)",[149,150,151,152,153,154,155,156,157,158,159],"Validation of HbA1c","Sulfasalazine","Salazopyrin","Continuous glucose monitoring","CGM","Type 2 Diabetes","Diabetes","Hemoglobin A1c","HbA1c","Type 1 Diabetes","Fasting blood glucose","2026-06-22",{"date":162,"type":43},"2026-06-25",{"date":164,"type":43},"2026-03-10",{"date":166,"type":22},"2026-10",{"name":168,"class":82},"Klavs Würgler Hansen",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":131},"100641853","bloodtrackr-usability-and-concordance-study-bucs-evaluating-a-smart-home-based-blood-collection-platform-for-remote-monitoring-in-rheumatoid-arthritis-100641853","NCT07660029","BloodTrackR Usability and Concordance Study (BUCS): Evaluating a Smart Home-Based Blood Collection Platform for Remote Monitoring in Rheumatoid Arthritis","BloodTrackR Usability and Concordance Study (BUCS)","BUCS","Inclusion Criteria:\n\n* Individuals living with rheumatoid arthritis, who attend community groups or rheumatoid arthritis charity groups\n* Aged 18 years or older\n* Able to understand written and spoken English\n* Individuals who have the capacity to consent\n* Access to WiFi and a smartphone\u002Ftablet\n\nExclusion Criteria:\n\n* Participants \\\u003C18years\n* Participants taking antibiotics\u002Fantivirals\n* No access to WiFi or a smartphone\u002Ftablet",{"count":178,"type":22},20,"The BloodTrackR Usability and Concordance Study (BUCS) is evaluating a novel home-based blood collection device and companion mobile application for people with rheumatoid arthritis. Participants will use the BloodTrackR device to collect a finger-prick blood sample at home and complete symptom assessments through the app.\n\nThe study will assess how easy the device and app are to use, whether participants can successfully collect high-quality blood samples outside of a healthcare setting, and how closely the results compare with standard venous blood samples collected by a phlebotomist. Findings will help determine the potential of BloodTrackR to support remote monitoring and reduce reliance on NHS phlebotomy services.",[30,181],"Remote Patient Monitoring",[183,184,181,185,186,187,188,189,190,191,192],"Rheumatoid Arthritis","Home Blood Collection","BloodTrackR","Blood Microsampling","CRP","Usability Study","Concordance Study","Digital Health","Mobile Health","Remote Monitoring","2026-06-19",{"date":73,"type":43},{"date":196,"type":22},"2026-06",{"date":198,"type":22},"2026-12",{"name":200,"class":82},"University of Ulster",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":91,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100612843","phase-1-a-study-of-ly4213663-in-healthy-participants-and-participants-with-rheumatoid-arthritis-100612843","NCT07258849","A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis","A Phase 1, Multicenter, Randomized, Placebo-Controlled, Investigator- and Participant-Blinded, Single- and Multiple-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4213663 in Healthy Participants, and Two Open-Label, Multiple-Dose Evaluations of LY4213663 in Patients With Rheumatoid Arthritis.","Inclusion Criteria:\n\n* Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg\u002Fm²), inclusive\n\nPart C and D Only:\n\n* Have a body weight at least 50 kilograms and BMI within the range 18.0 to 40.0 kg\u002Fm² (inclusive) at screening\n* Have a diagnosis of adult-onset RA for at least 3 months prior to screening\n\nExclusion Criteria:\n\nHealthy Participants for SAD Part A and MAD Part B Only:\n\n* Have a history or presence of cardiovascular, respiratory, hepatic, ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs\n\nParticipants with RA for Parts C and D Only:\n\n* Have Class 4 RA according to American College of Rheumatology (ACR) revised criteria\n* Have a 12-lead electrocardiogram (ECG) abnormality at screening\n* Have a current or recent acute active infection","75 Years",{"count":210,"type":22},141,[25],"The purpose of this study is to evaluate how well LY4213663 is tolerated and what side effects may occur in healthy participants and participants with rheumatoid arthritis (RA). The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).\n\nBlood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last approximately 33 weeks excluding screening.",[30],{"date":101,"type":43},{"date":216,"type":43},"2025-12-02",{"date":218,"type":22},"2028-03",{"name":220,"class":50},"Eli Lilly and Company",10,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":238,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":247,"leadSponsor":249,"locationsCount":131},"100644239","mobile-app-based-yoga-and-meditation-in-rheumatoid-arthritis-100644239","NCT07666594","Mobile App-Based Yoga and Meditation in Rheumatoid Arthritis","Effectiveness of a Mobile Application-Based Yoga and Meditation Program in Patients With Rheumatoid Arthritis: A Single-Blind Randomized Controlled Trial.","Inclusion Criteria:\n\n* Adults aged between 18 and 65 years.\n* Diagnosed with Rheumatoid Arthritis (RA) by a rheumatologist.\n* Disease in a stable phase (remission or low disease activity).\n* Access to a smartphone or tablet and sufficient proficiency in using mobile applications.\n* Cognitive sufficiency to provide written and verbal informed consent in Turkish.\n\nExclusion Criteria:\n\n* Presence of acute RA flare-ups.\n* Severe psychiatric diagnoses (e.g., psychosis, bipolar disorder, or severe major depression).\n* Severe cognitive impairment or dementia.\n* Pregnancy.\n* Regular practice of meditation or mindfulness within the last 6 months.\n* Participation in any other stress management program within the last 3 months.\n* Receipt of mental health services within the last 6 months.","65 Years",{"count":231,"type":22},102,[63],"The goal of this single-blind, randomized controlled trial is to evaluate the clinical effectiveness and short-term economic impact of a mobile application-based, personalized yoga and meditation program in adult patients with Rheumatoid Arthritis (RA).\n\nThe main questions it aims to answer are:\n\nDoes an 8-week digital yoga and meditation intervention reduce anxiety and improve other clinical\u002Fpsychological outcomes (such as depression, pulmonary function, reaction time, quality of life, and stress) compared to standard medical care? Does this digital intervention reduce short-term healthcare utilization and associated direct medical costs?\n\nResearchers will compare the Mobile App Group (receiving personalized yoga and meditation via the Meditopia app) to a Control Group (receiving usual medical care) to evaluate the effectiveness and cost-efficiency of the intervention.\n\nParticipants in the experimental group will:\n\nUse a mobile application to practice 15-30 minutes of yoga and 15-30 minutes of meditation daily, at least 4 days a week over an 8-week period.\n\nComplete clinical, psychometric, and economic assessments at baseline, week 4, and week 8.",[30,235,236,237],"Anxiety","Depression Anxiety Disorder","Mobile Health Technology (mHealth)",[183,239,240,241,242,243],"Yoga","Mobile Health (mHealth)","Meditation","Cost Analysis","Psychological Stress","2026-06-18",{"date":73,"type":43},{"date":196,"type":22},{"date":248,"type":22},"2027-06",{"name":250,"class":82},"Tugba Civi Karaaslan",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":263,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":284,"locationsCount":286},"100605492","at-home-ultrasound-localized-therapy-for-rheumatoid-arthritis-study-at-home-ultra-study-100605492","NCT07163221","At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]","At-home ULTRA","Inclusion Criteria:\n\n1. Males and females ages 18 and above\n2. Active moderate to severe seropositive RA\n3. At least 6 total tender and\u002For swollen joints counted on a 28 joint assessment during screening and at Week 0 (a joint that is both tender and swollen will be counted as \"2\")\n4. Demonstrated an inadequate response to, or loss of response to standard csDMARD treatment (e.g., methotrexate) or up to three total bDMARDs and tsDMARDs\n5. Receiving stable background treatment with a csDMARD prior to start of the treatment period at Week 0. Methotrexate (if chosen as background treatment) must be maintained at a stable dose for at least 4 weeks prior to Week 0, while all other csDMARDs (if chosen as background treatment) must be maintained at a stable dose for at least 8 weeks prior to Week 0. Participants must be willing to maintain their background medication regimen throughout the 28-week study period.\n6. For participants that have previously undergone treatment with bDMARDs or tsDMARDs therapy, those treatments must be discontinued at least 4 weeks prior to start of the treatment period at Week 0 and may not be resumed until after the Week 24 Closeout Visit\n7. For participants that have previously undergone treatment with Golimumab or Infliximab, those treatments must be discontinued at least 8 weeks prior to start of the treatment period at Week 0 and may not be resumed until after the Week 24 Closeout Visit\n8. Participants may receive up to 10 mg of daily prednisone as part of their background treatment but must have maintained a stable dose for a minimum of 6 weeks prior to start of the treatment period at Week 0, and must be willing to maintain the stable dose until after the Week 24 Closeout Visit\n9. Torso circumference at the belly button and sternum level must both be in the range of 25 to 50 inches\n10. Participants with an immunomodulation device must be willing and able to turn the device off at least 4 weeks prior to start of the treatment period at Week 0 and may not be resumed until after the Week 24 Closeout Visit\n11. Participants must be willing not to initiate any new treatments with expected immune modulating effects during the study period, and any existing immune modulating treatments must be stabilized by Week 0\n12. Participants must be willing and able to follow the medication rules described in the study's IRB-approved Medication Guide\n\nExclusion Criteria:\n\n1. Active bacterial or viral infection\n2. Pregnant women or those trying to become pregnant\n3. Receiving active chemotherapy or immunotherapy to treat malignancy within 30 days prior to enrollment\n4. Having received more than a total of three bDMARDs and tsDMARDs\n5. Having received Rituximab monoclonal antibody medication\n6. Presence of an implanted device or other solid object in the vicinity of the spleen that can interfere with or absorb the ultrasound beam\n7. History of asplenia\n8. History of splenomegaly\n9. History of ascites\n10. Recent abdominal surgery\n11. Currently participating in an investigational drug or device study\n12. Open wound\u002Fsores that would make performing study procedures too difficult\n13. Inability to perform minimal daily self-cares associated with feeding or dressing, such as lifting a cup of water to the mouth or putting on clothing.\n14. Refusal or inability to regularly attend the scheduled on-site visits and at-home visits, or perform the remote video observation sessions\n15. Cannot speak English\n16. Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study",{"count":259,"type":22},60,[63],"The At-Home ULTRA Study will evaluate performance of the MINI system as indicated for the treatment of adults with active, moderate to severe rheumatoid arthritis who are inadequate responders or are intolerant to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), or targeted synthetic DMARDs (tsDMARDs). The non-invasive study device delivers ultrasound stimulation to the spleen to reduce inflammation. The study will enroll at least 60 participants at up to 8 sites. There will be three arms consisting of two active stimulation groups (treatment) and one non-active stimulation group (sham-control). After completing the double-blinded primary endpoint assessment period at Week 12, there will be a one-way crossover of control participants to active stimulation and an additional 12 week follow-up with all participants to evaluate long-term outcomes.",[30],[264,265,266,183,267,268,269,270,271,272,273,274,275,276,277],"RA","SecondWave Systems","SecondWave","Neuromodulation","Ultrasound","Splenic Ultrasound","Spleen","Spleen stimulation","Ultrasound Stimulation","Immunomodulation","spleen stimulating device","drug refractory","noninvasive","non-invasive","2026-06-16",{"date":280,"type":43},"2026-06-17",{"date":282,"type":43},"2025-11-03",{"date":128,"type":22},{"name":285,"class":50},"SecondWave Systems Inc.",5,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":314,"locationsCount":4},"100641054","musculoskeletal-ultrasound-for-differentiating-rheumatoid-and-gouty-arthritis-100641054","NCT07657156","Musculoskeletal Ultrasound for Differentiating Rheumatoid and Gouty Arthritis","Role of Musculoskeletal Ultrasound in Differentiation of Rheumatoid Arthritis and Gouty Arthritis Using Semi-Quantitative Scoring","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Either sex.\n* Patients with clinically suspected or confirmed rheumatoid arthritis.\n* Patients with clinically suspected or confirmed gouty arthritis.\n* Patients referred for musculoskeletal ultrasound assessment of painful, swollen, or inflamed joints.\n* Patients able and willing to provide informed consent.\n* Patients whose final diagnosis is established by clinical assessment, laboratory testing, and\u002For relevant imaging or synovial fluid analysis when available.\n\nExclusion Criteria:\n\n* Patients younger than 18 years.\n* Patients with septic arthritis or suspected joint infection.\n* Patients with traumatic joint injury involving the target joint.\n* Patients with other inflammatory arthropathies such as psoriatic arthritis, reactive arthritis, or systemic lupus erythematosus if they may confound imaging interpretation.\n* Patients with advanced osteoarthritis in the scanned joint if it markedly limits Faculty of Medicine Institutional Review Board (IRB) Assiut Medical School Research Proposal Form 5 interpretation.\n* Patients with incomplete clinical records or insufficient ultrasound windows.\n* Patients who refuse consent.\n* Patients whose diagnosis remains uncertain after clinical workup.",{"count":295,"type":22},100,"Rheumatoid arthritis (RA) and gouty arthritis (GA) are two common forms of joint inflammation that can present with very similar physical symptoms, making them difficult to tell apart early in the disease process. Accurate and early differentiation is crucial because the treatment strategies and long-term management for the two conditions are substantially different.\n\nThe primary purpose of this observational study is to evaluate the diagnostic performance of musculoskeletal ultrasound (MSUS) in distinguishing between RA and GA. Ultrasound is a safe, radiation-free imaging tool that can visualize joint inflammation and structural changes in real-time. This study utilizes a structured semi-quantitative scoring system (graded on a scale of 0 to 3) to systematically measure the severity of joint lining thickness (synovial hypertrophy) and active blood flow (power Doppler signal). It also checks for crystal-related deposits, such as tophi or the double contour sign, which are highly suggestive of gout.\n\nParticipants aged 18 and older with suspected or confirmed RA or GA who are referred for joint assessment at Assiut University Hospitals will undergo a standard clinical evaluation, routine laboratory testing, and an ultrasound examination of specific target joints (such as the wrists, hands, knees, and ankles). By comparing the ultrasound scores and specific structural findings between the two patient groups, the study aims to establish a reliable, standardized imaging approach to help physicians make faster, more confident diagnoses and initiate the correct disease-specific therapies sooner.",[30,298,299,144],"Gouty Arthritis (GA)","Gout",[301,302,303,304,305,306,307,308],"Musculoskeletal Ultrasound","Semi-quantitative Scoring","Ultrasonography","Synovitis","Power Doppler","Double Contour Sign","Tophi","Diagnostic Imaging","2026-06-14",{"date":244,"type":43},{"date":312,"type":22},"2026-07",{"date":79,"type":22},{"name":315,"class":82},"Assiut University",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":18,"minAge":92,"maxAge":229,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":131},"100641973","gluten-free-vs-mediterranean-diet-in-rheumatoid-arthritis-100641973","NCT07646262","Gluten-Free vs Mediterranean Diet in Rheumatoid Arthritis","Investigation of the Effects of a Gluten-Free Diet and the Mediterranean Diet on the Inflammatory Index, Disease Activity, and Quality of Life in Patients With Rheumatoid Arthritis.","Inclusion Criteria:\n\nDiagnosis of rheumatoid arthritis according to ACR\u002FEULAR criteria Age between 19-65 years Stable medication regimen for at least 3 months prior to enrollment Willingness to comply with dietary interventions and study procedures Ability to provide informed consent\n\nExclusion Criteria:\n\nPregnancy or lactation Presence of other autoimmune or inflammatory diseases (e.g., SLE, IBD) Severe comorbidities (e.g., advanced cardiovascular, renal, or hepatic disease) Use of special diets (e.g., gluten-free diet) in the last 3 months Recent change in biologic or corticosteroid therapy (\\\u003C3 months) Food allergies or intolerances affecting dietary intervention adherence Inability to comply with dietary protocol or follow-up visits",{"count":324,"type":22},66,[63],"This study aims to evaluate the effects of different dietary interventions, including gluten-free, Mediterranean, and control diets, on disease activity, quality of life, and dietary inflammatory index in patients with rheumatoid arthritis. Participants will be followed for 12 weeks, and changes in clinical and nutritional outcomes will be assessed.",[328],"Rheumatoid Arthritis (RA",[67,330,331,332,333],"Mediterranean diet","Gluten-free diet","Dietary inflammatory index (DII)","Disease activity (DAS28)","2026-06-09",{"date":336,"type":43},"2026-06-12",{"date":338,"type":43},"2025-10-29",{"date":340,"type":22},"2026-08-31",{"name":342,"class":82},"Hasan Kalyoncu University",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":364,"locationsCount":366},"100623830","dysphagia-in-rheumatoid-arthritis-100623830","NCT07401732","Dysphagia in Rheumatoid Arthritis","Prediction of Dysphagia Severity and Diagnosis of Its Possible Causes in Rheumatoid Arthritis: A Cross-Sectional Study","Inclusion Criteria:\n\n* Patients with Rheumatoid arthritis defined by the American College of Rheumatology\u002FEuropean League Against Rheumatism collaborative initiative (ACR\u002FEULAR) 2010 classification criteria.\n* Patients aged above 18 years old, well-orientated, and cooperative.\n\nExclusion Criteria:\n\n* concomitant cancer diagnosis, pregnancy.\n* jaw-related traumas, teeth and gum diseases.\n* other rheumatologic conditions\n* other comorbidities.\n* other causes of TMJ arthritis, patients with TMJ, palatal or tongue congenital abnormalities, and patients who underwent TMJ injections in the last six months.\n* Patients with any language disorders or intellectually handicapped (as certain questions depend on the patient's ability to comprehend and express their emotions regarding their issue) and patients with anatomical anomalies impeding the functionality of flexible nasofibroscopy.\n* Any apparent causes of dysphagia other than RA.",{"count":351,"type":22},137,"The primary goal of this cross-sectional study is to assess risk factors\u002Fpredictors for dysphagia severity in RA.\n\nThe secondary goals include demonstrating whether flexible fiberoptic pharyngolaryngoscopy can diagnose joint-affection-induced dysphagia in patients with rheumatoid arthritis (RA) and whether both oropharyngeal and esophageal dysphagia are present among these patients.\n\nThe main questions it aims to answer are\n\n* What are the predictors that are associated with dysphagia severity via flexible fiberoptic pharyngolaryngoscopy in rheumatoid arthritis patients?\n* Whether flexible fiberoptic pharyngolaryngoscopy can diagnose joint-affection-induced dysphagia in patients with RA?\n* Whether both oropharyngeal and esophageal dysphagia are present in patients with RA?",[328],[355,356,357,358],"Flexible Endoscopic Evaluations of Swallowing","Temporomandibular joint","Deglutition disorders","cricoarytenoid","2026-06-06",{"date":334,"type":43},{"date":362,"type":43},"2026-02-07",{"date":312,"type":22},{"name":365,"class":82},"Tanta University",2,{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":91,"sex":18,"minAge":19,"maxAge":229,"enrollmentInfo":373,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":375,"conditions":376,"keywords":379,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":391,"locationsCount":131},"100643716","an-investigation-of-the-effect-of-smartphone-usage-levels-on-cervical-posture-tongue-pressure-balance-and-neck-disability-in-individuals-with-rheumatoid-arthritis-and-ankylosing-spondylitis-100643716","NCT07627542","An Investigation of the Effect of Smartphone Usage Levels on Cervical Posture, Tongue Pressure, Balance, and Neck Disability in Individuals With Rheumatoid Arthritis and Ankylosing Spondylitis","Inclusion Criteria:\n\n* Aged 18 to 65 years.\n* Using a smartphone for at least 2 hours daily.\n* Able to understand and follow postural commands during clinical measurements.\n* For the Rheumatoid Arthritis (RA) Group: Diagnosed with RA by a rheumatologist, with a stable disease activity score (DAS28 \\\u003C 3.2).\n* For the Ankylosing Spondylitis (AS) Group: Diagnosed with AS by a rheumatologist, with a stable disease activity score (BASDAI \\\u003C 4).\n\nExclusion Criteria:\n\n* History of prior surgical intervention in the cervical region.\n* Presence of neurological diseases (e.g., Parkinson's disease, ALS).\n* Severe visual or hearing impairment.\n* Vestibular system disorders.\n* Severe limitation in jaw opening.\n* Presence of acute neck trauma or malignancy.\n* Lower extremity amputation or advanced arthritis that prevents performing the balance test.\n* Active use of muscle relaxants or advanced sedative medications.",{"count":374,"type":22},111,"The purpose of this cross-sectional and comparative study is to investigate the impact of smartphone addiction on the cervical posture, musculoskeletal system, balance, and tongue pressure in individuals diagnosed with Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS), and to compare these findings with a healthy control group. Smartphone addiction has become a major contributing factor to postural alterations such as Text Neck Syndrome. This study aims to evaluate and compare the Craniovertebral Angle (CVA), neck extensor muscle strength, Pressure Pain Thresholds (PPT) of the neck and shoulder, Single-Leg Stance (SLS) static balance, and tongue pressure among three distinct groups. A healthy control group will be included as a reference baseline to differentiate the postural and functional deterioration caused by rheumatological diseases from the additional mechanical load imposed by smartphone dependency. To eliminate the misleading effects of acute pain, joint swelling, and severe functional limitations during flare-ups, only patients with stable disease activity (DAS28 \\\u003C 3.2 for RA and BASDAI \\\u003C 4 for AS) will be enrolled. This approach aims to examine the pure biomechanical relationship between technological dependency and cervical functions, independent of active systemic inflammation.",[30,377,378],"Ankylosing Spondylitis (AS)","Forward Head Posture",[380,381,382,383,384,385],"Text Neck","Smartphone Addiction","Neck Pain","Postural Balance","Neck Muscle Strength","Tongue Pressure","2026-06-05",{"date":334,"type":43},{"date":389,"type":43},"2026-04-09",{"date":128,"type":22},{"name":392,"class":82},"Merve Şahin",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":18,"minAge":400,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":403,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":4},"100643793","phase-4-comparison-of-effectiveness-and-safety-of-tofacitinib-versus-upadacitinib-as-add-on-to-methotrexate-in-rheumatoid-arthritis-100643793","NCT07636057","Comparison of Effectiveness and Safety of Tofacitinib Versus Upadacitinib as Add-on to Methotrexate in Rheumatoid Arthritis","Effectiveness and Safety of Tofacitinib Versus Upadacitinib as Add-on to Methotrexate in Rheumatoid Arthritis; Comparative Clinical Study","Inclusion Criteria:\n\n* • Adult patients aged ≥18 years, regardless of gender\n\nExclusion Criteria:\n\n* • Other autoimmune rheumatic disorders (SLE, psoriatic arthritis, AS, etc.)\n\n  * Administration of any biologic DMARD in the previous three months\n  * History of a serious infection (e.g., active tuberculosis or sepsis)\n  * Previous or existing history of recurrent infections or immunosuppressive status\n  * History of any malignancy in the last five years.\n  * Current chemotherapy, radiotherapy or intake of any genotoxic drug\n  * Severe liver impairment (e.g., ALT\u002FAST \\>3× ULN)\n  * Severe renal impairment (e.g., estimated GFR \\\u003C30 mL\u002Fmin)\n  * Severe Haematological Abnormalities: Hb \\\u003C8 g\u002FdL, TLC \\\u003C3,000 \u002Fmm³, Platelets \\\u003C100,000 \u002Fmm³\n  * Past or present deep vein thrombosis or pulmonary embolism\n  * Pregnant or lactating women\n  * Women of reproductive age who are not practicing adequate contraception measures","20 Years","55 Years",{"count":295,"type":22},[404],"PHASE4","The goal of this interventional study is to learn, whether Tofacitinib or upadacitinib is more effective in treating the patients of Rheumatoid Arthritis. It will also learn about the safety of these two agents. The main questions it aims to answer are:\n\n* Which JAK inhibitor (Tofacitinib or Upadacitinib) is more effective to improve the disease activity of Rheumatoid arthritis in Pakistani population?\n* What is the Disease Activity scores, ESR, CRP, RA factor level of patients?\n* What are the side effects of both drugs, during the study time?\n\nParticipants:\n\n* Of Group A will be taking 5mg Tofacitinib oral daily for 6 months along with 25mg of once weekly dose of oral Methotrexate, whereas of Group B will be taking 15mg Upadacitinib oral daily for 6 months along with 25mg of once weekly dose of oral methotrexate.\n* Will Visit the clinic once at 3 months and then 6 months for checkups and tests\n* Will Keep a diary of any infection, treatment taken, duration of infection\n* Will inform the researcher about any unusual side effect during the study",[30],"2026-06-04",{"date":334,"type":43},{"date":410,"type":22},"2026-07-05",{"date":412,"type":22},"2027-05-10",{"name":414,"class":82},"Sheikh Zayed Federal Postgraduate Medical Institute",{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":422,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":424,"briefSummary":425,"conditions":426,"keywords":427,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":131},"100643569","phase-2-desloratadine-as-adjunct-therapy-for-rheumatoid-arthritis-100643569","NCT07632872","Desloratadine as Adjunct Therapy for Rheumatoid Arthritis","Effect of Desloratadine as Add-On Therapy in Rheumatoid Arthritis","Inclusion Criteria:\n\n* Patients with active rheumatoid arthritis according to the 2010 American College of Rheumatology and European League Against Rheumatism classification criteria.\n* Disease Activity Score in 28 joints (DAS28) greater than 2.6.\n* Age between 18 and 60 years.\n* Male and female patients.\n* Patients receiving methotrexate in addition to standard conventional therapy.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with renal or hepatic disease.\n* Known hypersensitivity to the study medications.\n* Current use of antioxidant supplements.\n* History of psychiatric disorders.\n* Use of oral prednisolone at a dose greater than 15 mg per day.\n* Current treatment with biological disease modifying antirheumatic drugs.\n* Pregnant or breastfeeding patients.\n* History of cardiac arrhythmias or prolonged QT interval.\n* Use of medications known to prolong the QT interval.","60 Years",{"count":259,"type":22},[26],"Rheumatoid arthritis is a chronic inflammatory disease that causes joint pain, swelling, and reduced physical function. Although standard disease-modifying antirheumatic drugs are effective for many patients, some individuals continue to have active disease.\n\nThe purpose of this study is to evaluate the effectiveness and safety of adding desloratadine to standard therapy in patients with active rheumatoid arthritis. Participants will receive either desloratadine or placebo in addition to their usual treatment.\n\nThe study will assess changes in disease activity and inflammatory markers over a follow-up period of approximately 12 weeks. The results of this study may help determine whether desloratadine could be a useful add-on treatment option for patients with rheumatoid arthritis.",[30,183],[428,67,429,430,431],"Desloratadine","Add-on therapy","Inflammation","Randomized controlled trial","2026-06-02",{"date":434,"type":43},"2026-06-08",{"date":436,"type":43},"2026-05-23",{"date":438,"type":22},"2027-01",{"name":440,"class":82},"Horus University",{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":422,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":452,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":459,"locationsCount":131},"100643188","phase-2-effect-of-roflumilast-as-add-on-therapy-in-rheumatoid-arthritis-100643188","NCT07632846","Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis","Inclusion Criteria:\n\n* Patients with active rheumatoid arthritis according to the 2010 American College of Rheumatology and European League Against Rheumatism classification criteria.\n* Disease Activity Score in 28 joints (DAS28) greater than 2.6.\n* Age between 18 and 60 years.\n* Male and female patients.\n* Patients receiving methotrexate in addition to standard conventional therapy.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Exclusion Criteria:\n* Patients with renal or hepatic disease.\n* Known hypersensitivity to the study medications.\n* Current use of antioxidant supplements.\n* History of psychiatric disorders.\n* Use of oral prednisolone at a dose greater than 15 mg per day.\n* Current treatment with biological disease modifying antirheumatic drugs.\n* Pregnant or breastfeeding patients.\n* History of cardiac arrhythmias or prolonged QT interval.\n* Use of medications known to prolong the QT interval",{"count":448,"type":22},50,[26],"Rheumatoid arthritis is a chronic inflammatory disease that causes joint pain, swelling, and reduced physical function. Although standard disease-modifying antirheumatic drugs are effective for many patients, some individuals continue to have active disease.\n\nThe purpose of this study is to evaluate the effectiveness and safety of adding roflumilast to standard therapy in patients with active rheumatoid arthritis. Participants will receive either roflumilast or placebo in addition to their usual treatment.\n\nThe study will assess changes in disease activity and inflammatory markers over a follow-up period of approximately 12 weeks. The results of this study may help determine whether roflumilast could be a useful add-on treatment option for patients with rheumatoid arthritis.",[183,30],[453,67,431,454,429],"Roflumilast","Phosphodiesterase-4 inhibitor",{"date":434,"type":43},{"date":457,"type":43},"2026-05-19",{"date":198,"type":22},{"name":440,"class":82},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":18,"minAge":467,"maxAge":468,"enrollmentInfo":469,"targetDuration":4,"studyType":23,"phases":471,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":131},"100640639","phase-2-complementary-herbal-approach-to-rheumatoid-management-study-charms-100640639","NCT07627893","Complementary Herbal Approach to Rheumatoid Management Study (CHARMS)","CHARMS","Inclusion Criteria:\n\n1. Patients between the ages of 21 and 70 years, and diagnosed with RA by a rheumatologist and fulfilling the 2010 ACR\u002FEULAR classification criteria for RA.\n2. Active disease with DAS28 ESR ≥3.2 at screening, with at least 6 swollen joints out of 66 and at least 6 tender joints out of 68.\n3. Receiving stable doses of methotrexate therapy for at least 3 months, and on stable dose for at least 4 weeks before trial entry ( ≥10mg per week), either subcutaneous or orally.\n4. Stable doses of non-steroidal anti-inflammatory drugs (NSAIDS), acetaminophen, or oral corticosteroids (equivalent to prednisone ≤ 10 mg) for at least 4 weeks prior to first dose of study medication.\n5. Except for methotrexate, patients must have discontinued all csDMARDs, including, but not limited to: hydroxychloroquine, sulfasalazine, leflunomide prior to first dose of study medication as specified below:\n\n   1. ≥ 4 weeks prior to Baseline Visit for sulfasalazine and hydroxychloroquine\n   2. ≥ 8 weeks prior to Baseline Visit for leflunomide if no elimination procedure was followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal)\n6. A negative urine pregnancy test for women of childbearing potential on Day 1 (prior to administration of first dose of study drug).\n7. Use of a reliable method of contraception by all female patients of childbearing potential and male patients with procreative capacity during the study and up to 3 months after the last dose of the study medication.\n\nExclusion Criteria:\n\n1. Not able to provide informed consent.\n2. Previous lack of efficacy to Si Miao Xiao Bi Tang.\n3. History of inflammatory joint disease other than RA. Secondary Sjogren's Syndrome is permitted.\n4. Concurrent use of other immunosuppressant medications, except MTX and protocol allowed doses of steroids.\n5. Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point administration of corticosteroids in the preceding 4 weeks prior to the Baseline Visit.\n6. Subject has been treated with any investigational drug within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Baseline Visit or is currently enrolling in another clinical study.\n7. Pregnant or breastfeeding females.\n8. Infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses, untreated malignancy, or evidence of active or untreated latent tuberculosis.\n9. Receipt of any live vaccine within 1 month prior to the Screening Visit, or expected need of live vaccination during study participation including up to 1 month after the last dose of study drug.\n10. History of clinically significant hematologic, pulmonary, renal, hepatic, or psychiatric disease that would interfere with the subject's participation in this study.\n11. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Day 1 or oral anti-infectives within 14 days prior to the Baseline Visit.\n12. Any uncontrolled clinically significant laboratory abnormality or any of the following laboratory abnormalities:\n\n    1. Evidence of hematopoietic disorder or hemoglobin \\\u003C9 g\u002FdL\n    2. White blood cell count \\\u003C3.0 x 10\\^9\u002FL (\\\u003C3000\u002Fmm\\^3)\n    3. Absolute neutrophil count \\\u003C1.2 x 10\\^9\u002FL (\\\u003C1000\u002Fmm\\^3)\n    4. Platelet count \\\u003C100 x 10\\^9\u002FL (\\\u003C100,000\u002Fmm\\^3)\n    5. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal (ULN)\n    6. Estimated glomerular filtration rate of less than 60 mL\u002Fmin\n13. Any arrhythmia on baseline\u002Fscreening ECG.\n14. Females of childbearing potential not willing to use contraceptive methods which, in the opinion of the investigator, are effective and adequate while on the study. Female subjects who are not of childbearing potential must meet at least one of the following criteria: (a) Have undergone a documented hysterectomy and\u002For bilateral oophorectomy; or (b) Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause.\n15. Been diagnosed with G6PD deficiency.\n16. Subjects who are taking TCM supplements regularly (daily) and not willing to stop intake.","21 Years","70 Years",{"count":470,"type":22},132,[26,472],"PHASE3","Rheumatoid Arthritis (RA) is a chronic disease characterised by symmetric, polyarticular pain and swelling, involving small joints of the hands and feet. RA can lead to irreversible joint damage without treatment, causing disability and impacting daily activities and work productivity. Some patients turn to Chinese Herbal Medication (CHM) for treatment. Since there is currently no well designed randomised controlled trial to support the 'real-world' use of Si Miao Xiao Bi Tang with anti-rheumatic drugs, such as methotrexate, the investigators are conducting a 12-week, randomised double-blinded placebo-controlled trial to determine the efficacy, safety and cost effectiveness of a modified Si Miao Xiao Bi Tang, a type of CHM, in the treatment of patients with active RA.",[30],[183,476,477,478],"Chinese Herbal Medicine","Traditional Chinese Medicine","Si Miao Xiao Bi",{"date":407,"type":43},{"date":481,"type":22},"2026-06-01",{"date":483,"type":22},"2030-06-30",{"name":485,"class":82},"Singapore General Hospital",{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":493,"targetDuration":4,"studyType":23,"phases":495,"briefSummary":496,"conditions":497,"keywords":503,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":512,"leadSponsor":514,"locationsCount":366},"100627972","phase-1-study-of-s-4321-in-participants-with-an-autoimmune-or-immune-mediated-disease-100627972","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.",{"count":494,"type":22},24,[25],"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).",[498,30,499,500,501,502],"Autoimmune Diseases","Psoriatic Arthritis (PsA)","Psoriasis (PsO)","Cutaneous Lupus Erythematosus (CLE)","Atopic Dermatitis (AD)",[504,505,506,507,183,502,500,499,501,508],"Autoimmune","Immune-mediated","S-4321","Seismic Therapeutic","Cutaneous Lupus","2026-05-28",{"date":481,"type":43},{"date":196,"type":22},{"date":513,"type":22},"2027-09",{"name":515,"class":50},"Seismic Therapeutic AU Pty Ltd",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":523,"targetDuration":4,"studyType":23,"phases":525,"briefSummary":526,"conditions":527,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":538},"100565814","phase-1-a-study-to-evaluate-the-safety-and-activity-of-sar448501dr-0201-in-patients-with-autoimmune-rheumatic-diseases-100565814","NCT06647069","A Study to Evaluate the Safety and Activity of SAR448501\u002FDR-0201 in Patients With Autoimmune Rheumatic Diseases","A Phase 1, Open-label, Multiple Ascending Dose Basket Study to Evaluate the Safety and Activity of SAR448501\u002FDR-0201 in Patients With Select Autoimmune Rheumatic Diseases","Inclusion Criteria:\n\n* Diagnosis of SLE and\u002For RA. American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria should be used.\n* Contraception during the study intervention period and for at least 140 days after the last administration of study intervention: Male participants must agree to refrain from donating or cryopreserving sperm, and either be abstinent or use contraception\u002Fbarrier. Female participants must use of a highly effective contraceptive measure for all females of childbearing potential. Females of childbearing potential need to have a negative serum pregnancy test within 7 days prior to the first dose.\n* Specific to Systemic Lupus Erythematosus (SLE):\n\n  * Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score ≥8 at screening with at least 4 points from clinical features at screening.\n  * At least 1 British Isles Lupus Assessment (BILAG) A score or 1 BILAG B score at screening\n  * Positive ANA (titer ≥1:80) as documented in the participant's medical history\n  * Positive for any of the following as documented in the participant's medical history: antidsDNA, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies\n  * Inadequate response to systemic glucocorticoids and to at least 1 therapy other than antimalarials for at least 12 weeks including: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin.\n* Specific to Rheumatoid Arthritis (RA):\n\n  \\-- Moderate-to-severe disease activity as defined by a 28-joint disease activity score using C reactive protein (DAS28-CRP) \\>3.2 at screening.\n* Inadequate response or intolerance to at least 2 disease-modifying antirheumatic drugs (DMARDs, at least 1 biologic \\[bDMARD\\] or targeted synthetic \\[tsDMARD\\]) after a minimum of 12 weeks treatment duration.\n* At least 6 tender joints at screening.\n* At least 6 swollen joints at screening.\n* Methotrexate (MTX) for at least 12 consecutive weeks, and at a stable dose of ≤25 mg\u002Fweek oral or SC since at least 4 weeks prior to randomization, OR - in case of MTX intolerance - conventional DMARDs at a stable dose for at least 28 days.\n* If taking MTX, compliant with folic acid 1 mg daily or 5 mg weekly or greater in combination with MTX.\n\nExclusion Criteria:\n\n* Severe manifestation of the selected autoimmune rheumatic diseases under study that could impact participant safety, or is likely to require interventions that will affect investigational drug PD.\n* Receipt of super-high potency (eg, clobetasol propionate, betamethasone dipropionate) or high potency (eg, fluocinonide, methylprednisolone aceponate) topical corticosteroids within 28 days prior to screening, had dose changes in other topical corticosteroids within 14 days prior to Day 1, or had dose changes in nonsteroidal topical immunosuppressants within 28 days prior to Day 1.\n* Received dose changes of mycophenolate mofetil, methotrexate, leflunomide, calcineurin inhibitors, JAK inhibitors, or azathioprine within 28 days prior to Day 1.\n* Receipt of any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide \\>20 mg\u002Fday, abatacept.\n* Receipt of any mAb or experimental immunomodulator within 28 days or 5 published half-lives prior to Day 1, whichever is longer.\n* Receipt of rituximab or other B cell depleting biologics within 6 months of Day 1.\n* Receipt of rituximab or other B cell depleting biologics without return of CD19 or CD20 count to above the LLN.\n* Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, CAR-T or T cell vaccination therapy.\n* Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, positive result for HIV infection, splenectomy, or any underlying condition that predisposes the participant to infection.\n* History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.\n* Active infection or a history of serious infections as defined in the protocol.\n* Surgery within 28 days prior to Day 1.\n* 12-lead ECG parameters after 10 minutes resting in supine position NOT in the defined normal ranges.\n* Evidence of significant, uncontrolled concurrent disease that could affect compliance with the study (eg, chronic obstructive pulmonary disease).\n* Diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of basal cell or squamous epithelial carcinomas of the skin that have been resected or cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline.\n* High dose of antimalarial or a change in dose within 28 days prior to Day 1.\n* Receipt of systemic corticosteroids \\>20 mg\u002Fday (prednisone or equivalent) or had dose changes of systemic corticosteroids within 28 days prior to Day 1.\n* Documented liver disease including documented diagnosis of cirrhosis.\n* Participants with a history of hypercoagulation event or thrombosis (such as venous thromboembolism, pulmonary embolism, or stroke), or participants who have known hypercoagulation risk factors (including antiphospholipid syndrome), or participants currently on anticoagulation will be excluded.\n* Specific to SLE:\n\n  * Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis at screening.\n  * Known biopsy-proven diagnosis of lupus nephritis (any class) or otherwise unexplained proteinuria (0.5g protein\u002F24h; or urine protein\u002Fcreatinine ratio \\>0.5g\u002Fg) at screening.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":524,"type":22},62,[25],"This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The purpose of the study is to identify possible optimal dose(s) by assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary clinical response of SAR448501\u002FDR-0201.\n\nThe study duration per participant will be a minimum of approximately 13 months, including a screening period of up to 28 days, a treatment period of 71 days, and a follow-up period of 42 weeks. If necessary, participants will continue to have visits after End of Study (EOS) every 4 weeks until peripheral blood B cells return to at least 80% of either the lower limit of normal (LLN) or the participant's baseline value.",[528,30],"Systemic Lupus Erythematosus (SLE)","2026-05-21",{"date":531,"type":43},"2026-05-22",{"date":533,"type":43},"2025-03-27",{"date":535,"type":22},"2029-06-25",{"name":537,"class":50},"Sanofi",7,{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":547,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":23,"phases":550,"briefSummary":551,"conditions":552,"keywords":557,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":571},"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":549,"type":22},1944,[404],"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.",[30,499,553,528,554,555,556],"Axial Spondy","Caridovascular Disease","Atherosclerosis","Carotid Artery Diseases",[558,559,560,561,562],"Carotid ultrasound","Carotid plaques","Subclinical atherosclerosis","Cardiovascular prevention","Inflammatory rheumatic diseases","2026-05-20",{"date":509,"type":43},{"date":566,"type":43},"2026-04-22",{"date":568,"type":22},"2031-12",{"name":570,"class":82},"Instituto de Investigación Marqués de Valdecilla",17,{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":590,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":613},"100592260","phase-2-allonk-an-allogeneic-non-genetically-modified-cord-blood-derived-nk-cell-therapy-in-combination-with-rituximab-studied-in-relapsing-forms-of-b-cell-dependent-rheumatologic-diseases-100592260","NCT06991114","AlloNK®, an Allogeneic Non-genetically Modified, Cord Blood-derived NK Cell Therapy, in Combination With Rituximab, Studied in Relapsing Forms of B-cell Dependent Rheumatologic Diseases.","An Open-label Phase 2a Study to Evaluate the Safety and Efficacy of AlloNK®, an Allogeneic Cord Blood-derived NK Cell Therapy, in Combination With Rituximab in Relapsing Forms of B-cell Dependent Rheumatologic Diseases","For Subjects with Refractory Rheumatoid Arthritis (RA):\n\n* Documented diagnosis of RA, meeting the 2010 ACR\u002FEULAR classification criteria.\n* Rheumatoid Factor (RF) or Anti Citrullinated Protein Antibody (ACPA) positive.\n* High-sensitivity C-reactive protein (hs-CRP) \\> 3 mg\u002FL or Erythrocyte Sedimentation Rate (ESR) \\> 28 mm\u002Fhr.\n* Have had prior treatment for a period of at least 12 weeks with a biologic disease modifying anti-rheumatic drug and were deemed refractory by the treating physician.\n* Minimum of six swollen joint counts (SJC) and six tender joint counts (TJC) according to joint assessment.\n\nFor subjects with Sjögren's Disease (SjD)\n\n* Prior diagnosis of Primary SjD as per 2016 ACR\u002FEULAR criteria with confirmatory diagnosis in the 24 weeks preceding screening.\n* Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) \\> 6.\n* Salivary Flow Rate \\> 0.1 mL\u002Fmin on stimulation.\n\nFor subjects with Idiopathic Inflammatory Myopathies (IIMs)\n\n* Presence of a positive autoantibody (ANA \\>1:80 or RNP or SSA\u002FSSB or other myositis specific autoantibodies.\n* Refractory IIM as defined by inadequate response\u002Fintolerance to at least 3 months of glucocorticoids and\u002For at least one other immunosuppressive.\n* Muscle biopsy or muscle MRI to confirm IIM diagnosis, where applicable, within 12 months prior to enrollment.\n\nFor Subjects with Systemic Sclerosis (SSc)\n\n* Diagnosis of SSc in accordance with the ACR\u002FEULAR 2013 classification.\n* Modified Rodnan skin score (mRSS) \\> 10.\n* Initial confirmatory diagnosis within 8 years of screening.\n* Refractory SSc as defined by inadequate response\u002Fintolerance to at least 3 months of glucocorticoids and\u002For at least one other immunosuppressive.",{"count":118,"type":22},[26],"A Basket Trial of Refractory Rheumatoid Arthritis (RA), Sjögren's Disease (SjD), Idiopathic Inflammatory Myopathies (IIMs) and Systemic Sclerosis (SSc) subjects to evaluate the safety and efficacy of AlloNK, a non-genetically modified allogeneic NK cell, in combination with rituximab.",[583,584,31,328,585,586,587,588,589],"Refractory Rheumatoid Arthritis (RA)","Idiopathic Inflammatory Myopathies (IIMs)","IIM","Myositis","Scleroderma","Sjogren Syndrome","Sjogrens Disease",[591,592,593,594,595,596,597,598,599,600,601,602,603,604,605],"Refractory Rheumatoid Arthritis","AlloNK","Idiopathic Inflammatory Myopathies","Systemic Sclerosis","Sjögren's Disease","Refractory RA","Cell Therapy","Allogeneic NK Cells","Allogeneic Cell Therapy","non-genetically modified","rituximab","cord blood cells","ADCC enhancement","outpatient","community",{"date":531,"type":43},{"date":608,"type":43},"2025-07-09",{"date":610,"type":22},"2029-01",{"name":612,"class":50},"Artiva Biotherapeutics, Inc.",52,{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":621,"targetDuration":4,"studyType":23,"phases":623,"briefSummary":624,"conditions":625,"keywords":626,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":637},"100592493","phase-1-a-study-of-cln-978-a-subcutaneously-administered-cd19-directed-t-cell-engager-in-subjects-with-rheumatoid-arthritis-100592493","NCT06994143","A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis","A Phase I, Open-Label Study of CLN-978 in Patients With Treatment-Refractory Rheumatoid Arthritis (RA)","Inclusion Criteria:\n\n* Documented diagnosis of RA which fulfills the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) Classification Criteria ≥12 weeks prior to screening.\n* Evidence of B-cell-driven disease at Screening or previous medical documentation, defined as either (i) seropositivity for RF and\u002For any AMPA and\u002For (ii) a synovial biopsy showing B-cell infiltration\n* Active RA disease, as demonstrated by a DAS28 - ESR ≥3.2 and at least one swollen joint at screening.\n* Inadequate response to at least 2 targeted treatments with different mechanisms. These can include tsDMARD and\u002For bDMARD, after failing conventional synthetic DMARD (unless contraindicated).\n* Local laboratory assessments must meet the following criteria:\n\n  * Absolute lymphocyte count (ALC) ≥0.5 x 10\\^9\u002FL\n  * Peripheral CD19+ B cell count ≥25 cells\u002FμL\n  * Absolute neutrophil count (ANC) ≥1.0 x 10\\^9\u002FL\n  * Hemoglobin (Hgb) ≥8 g\u002FdL\n  * Platelet count ≥75 x 10\\^9\u002FL\n  * Estimated glomerular filtration rate (eGFR) (based on the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] formula) ≥30 mL\u002Fmin\u002F1.73m\\^2\n  * Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN\n* Concurrent corticosteroids is permitted if the dose is ≤10 mg\u002Fday prednisone equivalent in the 2 weeks prior to initiation of study treatment. Hydroxychloroquine ≤400 mg\u002Fd or chloroquine ≤ 250 mg\u002Fd is allowed.\n\nExclusion Criteria:\n\n* Active inflammatory disease other than RA within 12 months prior to screening or during screening that may interfere with the study assessments. Thyroiditis or secondary Sjogren's syndrome is allowed.\n* Clinical evidence of any other significant unstable or uncontrolled acute or chronic disease not due to RA which, in the opinion of the Investigator could put the patient at undue risk or confound study results.\n* Prior treatment with the following:\n\n  * Cellular therapy (e.g., chimeric antigen receptor T-cell (CAR-T) or gene therapy product directed at any target.\n  * Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1 and during the study.\n  * Received any anti-CD19 or anti-CD20 therapy such as blinatumomab, obinutuzumab, rituximab, ocrelizumab, or ofatumumab within 3 months prior to Day 1.\n  * Non-biologic DMARD within 14 days prior to Day 1.\n  * Cyclophosphamide or a biologic immunomodulating therapy within 2 months of Day 1.\n* Live or live-attenuated vaccines within the 4 weeks prior to the Screening visit or during the Screening Period\n* Active or latent tuberculosis (TB) evidenced by a positive or indeterminant Interferon Gamma Release Assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB.",{"count":622,"type":22},37,[25],"A Phase I, open-label study of CLN-978 in patients with treatment-refractory rheumatoid arthritis.",[328],[264,627],"Treatment-refractory RA","2026-05-13",{"date":630,"type":43},"2026-05-15",{"date":632,"type":43},"2025-05-19",{"date":634,"type":22},"2028-12-30",{"name":636,"class":50},"Cullinan Therapeutics Inc.",3,{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":208,"enrollmentInfo":646,"targetDuration":4,"studyType":23,"phases":647,"briefSummary":648,"conditions":649,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":659,"leadSponsor":661,"locationsCount":131},"100637500","a-study-to-evaluate-mtm-h-001-injection-in-adult-patients-with-b-cell-related-autoimmune-diseases-100637500","NCT07593911","A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases","An Open-Label, Single-Arm, Dose-Escalation and Expansion Basket Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Efficacy of MTM-H-001 in Patients With B-Cell-Related Autoimmune Diseases (ArchAid-002)","ArchAid-002","Inclusion Criteria:\n\n* Key inclusion criteria include：\n\n  1. Male or female, aged 18 - 75 years old (inclusive);\n  2. The participant or his\u002Fher legally acceptable representative gives consent to this clinical study participation and signs an Informed Consent Form (ICF) indicating their understanding of the objectives and procedures of the clinical study and willingness to participate in the study;\n  3. Confirmed diagnosis of the target autoimmune disease per international classification criteria;\n  4. Adequate organ function to tolerate treatment;\n  5. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and agree to use at least one effective contraceptive method throughout the study and within 6 months after the last treatment cycle.\n\nExclusion Criteria:\n\n* Key exclusion criteria include:\n\n  1. Active, severe, uncontrolled infection;\n  2. Pregnancy or breastfeeding women;\n  3. History of malignancy within the protocol-defined period, except adequately treated low-risk cancers;\n  4. Any condition that, in the investigator's opinion, would compromise safety, compliance, or interpretability of study data.",{"count":141,"type":22},[63],"This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with B-cell-related autoimmune diseases.",[650,651,652,653,654,30],"Systemic Lupus Erthematosus (SLE)","Lupus Nephritis (LN)","Multiple Sclerosis","Myasthenia Gravis (MG)","IgG4-Related Diseases","2026-05-12",{"date":657,"type":43},"2026-05-18",{"date":196,"type":22},{"date":660,"type":22},"2031-06",{"name":662,"class":82},"Beijing GoBroad Hospital",{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":4,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":670,"enrollmentInfo":671,"targetDuration":4,"studyType":23,"phases":673,"briefSummary":674,"conditions":675,"keywords":681,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":131},"100599529","phase-1-phase-1-study-of-hbi0101-car-t-in-refractory-b-cell-autoimmune-diseases-100599529","NCT07085676","Phase 1 Study of HBI0101 CAR-T in Refractory B-Cell Autoimmune Diseases","A Phase 1 Dose Escalation and Safety Study of HBI0101 CART in B-cell Mediated Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Age: 18\\~80 years old; for patients aged ≥ 75 years, geriatric assessment and endorsement are required;\n2. Diagnosis of B-cell mediated ARDs listed below:\n\n   SLE patients: individuals diagnosed with SLE according to American College of Rheumatology (ACR) and\u002For Systemic lupus international collaborating clinics (SLICC) classification criteria, who have severe and progressive disease course reflected by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of 8 or more. Eligible patients must have failed to at least one of the conventional DMARDs (azathioprine, methotrexate, mycophenolate mofetil or cyclophosphamide), one of the calcineurin inhibitors (tacrolimus or cyclosporin) and one of the biologic agents (belimumab, rituximab or aniflorumab), each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories. The failure is defined as:\n   * lack of response per SLEDAI-2k (\\\u003C4 points reduction from baseline) or no improvement in BILAG domains, or\n   * disease flare per SLEDAI-2k (≥4 points increase from baseline) or new BILAG A or ≥2 new BILAG B organ scores, or intolerance or discontinuation due to adverse effects.\n\n   SSc patients: Patients who were diagnosed with diffuse or limited cutaneous SSc according to the College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR-EULAR) classification criteria, with severe or rapidly progressive disease Eligible patients must meet any of the following criteria:\n   * Progression of skin thickening ≥ 12 over the past 6 months or Modified Rodnan skin score (mRSS) ≥15\n   * Any Medsger Disease Severity Score grade 3-4 in one major organ or grade ≥2 in two organs\n   * Progressive interstitial lung disease evidenced by HRCT or FVC \\\u003C80% or DLCO \\\u003C80%, or evidence of pulmonary function decline, defined as an absolute FVC decline of ≥ 10% , or FVC decline of 5% -9% combined with DLCO 15%.\n   * Other internal organ involvement.\n\n   Eligible patients must have failed to at least two state-of-the-art immunosuppressive therapies including MTX, MMF, cyclophosphamide, azathioprine, nintedanib, tocilizumab or rituximab; each therapy must have been administered for a minimum of 3 months, unless discontinued due to a contraindication or toxicity. The failure is defined as:\n   * lack of response in skin per mRSS (≤20% relative and ≤5 point absolute reduction from baseline) or no clinically meaningful improvement in FVC, DLCO, or other organ involved assessed by Medsger DSS, or\n   * disease flare in skin per mRSS (increase in mRSS ≥20% and ≥5 points from baseline) or decline in FVC ≥10% predicted or in DLCO ≥15% predicted from baseline, other major SSc complication, or\n   * intolerance or discontinuation due to adverse effects\n\n   IIM, including dermatomyositis, anti-synthetase syndrome, immune mediated necrotizing myopathy, and polymyositis: patients must be diagnosed with IIM according to the 2017 ACR\u002FEULAR Classification Criteria for idiopathic inflammatory myopathies.\n\n   Eligible patients must have active disease, defined by at least one of the following:\n   * CPK ≥4xULN\n   * Loss of muscle strength in the weakest muscle group for less than 80% per MMT8\n   * Evidence on MRI of active myositis within last 6 months\n   * Evidence on EMG of active myositis within last 6 months\n   * Muscle biopsy evidence of active myositis within last 6 months\n\n   Only patients with refractory disease will be recruited, defined as previous failure to (1) at least two of five non-glucocorticoids immunosuppressive therapies and (2) either rituximab or IVIG, each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories. The five non-glucocorticoids therapies considered are azathioprine, MTX, MMF, IVIG, and rituximab The failure is defined as:\n   * lack of response in muscle strength per MMT-8 or CPK (\\\u003C20% relative improvement) or per MRI or\n   * disease flare in muscle strength per MMT-8 (≥30% decline) or CPK (≥30% rise) or objective worsening of other organ involvement per Myositis Disease Activity Assessment Tool or\n   * intolerance or discontinuation due to adverse effects\n\n   RA patients: Seropositive RA patients (positive for anti-cyclic citrullinated peptide and rheumatoid factor), diagnosed according to the 2010 ACR\u002FEULAR classification criteria.\n\n   Eligible patients must exhibit high disease activity (DAS28CRP ≥5.1), and be resistant to at least four conventional synthetic and biologic disease-modifying antirheumatic drugs (DMARD) groups.\n\n   Each patient must have previously received at least one medication from each of the mentioned groups, including\n   * JAK-STAT inhibitors\n   * Anti-TNF agents\n   * Anti-IL6 drugs\n   * Anti-CTLA4-Ig treatments, each administered for a minimum of 3 months, or have a contraindication to, or have experienced toxicity from, any therapy within these categories\n\n   Drug resistance is defined as:\n   * Inadequate clinical response measured by composite score DAS28CRP (\\> 3.6) or failure to reach ACR20 or\n   * Disease progression measured by DAS28CRP (≥20% increase) or radiographic progression or\n   * Intolerance or discontinuation due to adverse effects\n\n   NMOSD: Patients must be diagnosis of AQP4-IgG-positive NMOSD based on the 2015 International Panel for NMOSD Diagnosis (IPND) criteria (Wingerchuk et al., 2015).\n\n   Eligible patients must have experienced at least two relapses in the past 24 months, with at least one occurring in the preceding 12 months before screening Each patients must have previously received with inadequate disease control (one or more clinical attacks, with new MRI activity, despite adequate treatment dosing) at least one immunosuppressant for at least 6 months (azathioprine or mycophenolate mofetil) and\u002For Rituximab for at least 3 months and\u002For a targeted therapy (eculizumab, inebilizumab, or satralizumab) or must have a contraindication to such treatment.\n\n   MS patients: must have confirmed history of diagnosis of primary progressive or secondary progressive MS .\n\n   Eligible patients must have: Expanded Disability Status Scale (EDSS) score between 3.0 and 8.5 and evidence of disease activity, defined by either clinical progression and\u002For radiological finding on MRI, such as new, enhancing or enlarging lesions in the last 12 months.\n\n   Eligible patient must have previously received at least one high efficacy drug and have been offered standard treatments and have experienced disease progression or lack of efficacy despite at least six months of treatment. These will include clinical activity (new relapse\\[s\\]), radiological activity (new or enlarging T2 lesions and\u002For gadolinium-enhancing lesions on MRI), or confirmed disability progression (an increase in least 1 point on the EDSS sustained for ≥6 months).\n\n   Eligible patient must have history of treatment with anti-CD20 mAb with continuing evidence of worsening physical disability over a period of ≥6 months, with documented clinical disability progression within the year prior to inclusion, irrespective to concurrent MRI activity.\n\n   MG patients must meet all the following criteria:\n\n   \\- Confirmed diagnosis of generalized MG, supported by positive autoantibodies (anti-AChR, anti-MuSK).\n\n   Disease Severity:\n   * Myasthenia Gravis Activities of Daily Living (MG-ADL) score of ≥6, with ocular symptoms constituting less than 50% of the total score.\n   * Myasthenia Gravis Foundation of America (MGFA) clinical classification of II to IV.\n\n   Eligible patients must have Refractory Status and meet at least one of the following criteria:\n   * No improvement or worsening myasthenic symptoms, with failure to achieve minimal manifestation status or meaningful improvement in MGFA class or MG-ADL score, or recurrent myasthenic exacerbations despite adequate immunosuppressive or immunomodulatory therapy for at least 6 months for all therapies and 3 months for B cell depletion therapy\n   * Improvement in Post-Intervention Status (PIS), but with an MG-ADL score ≥6 persisting for at least 4 months.\n   * Remission or improvement in PIS, but with ≥1 episode of disease exacerbation (MG-ADL ≥6) per year during tapering of immunotherapy medications.\n   * After experiencing a myasthenic crisis, patients who undergo multiple immunotherapies (e.g., intravenous immunoglobulin, plasma exchange, high-dose intravenous methylprednisolone), thymectomy, and active infection control but still cannot be weaned off the ventilator due to MG-induced respiratory muscle weakness for more than 14 days.\n\n   Each patient must receive stable doses of medication prior to enrollment.\n\n   Refractory APLA patients: must have confirmed history of APLA, based on Sydney 2006 or ACR\u002FEULAR 2023 criteria\n\n   \\- Eligible patients must have medium to high-titer antiphospholipid antibodies, documented repeatedly (≥2 tests spanning 12 weeks) Eligible patients must have refractory disease: persistent or recurrent arterial thrombosis, venous thrombosis or diffuse alveolar hemorrhage despite conventional therapy with stable treatment with vitamin K antagonist anticoagulation (maintained at therapeutic stable dose keeping INR consistently within target range) and immunosuppression treatment including glucocorticoid, rituximab and Plaquenil\n3. AST\u002FALT below 5 times the upper limit of normal, blood bilirubin below 3 times the upper limit of normal ;\n4. Cardiopulmonary function is basically normal, echocardiography indicates that the ejection fraction is \\>45%, normal to mild pulmonary hypertension, and the oxygen saturation is above 93% in the resting state without oxygen;\n5. No obvious active infection;\n6. There are no contraindications for blood collection;\n7. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study;\n8. Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative.\n9. Ability and willingness to adhere to the study visit schedule and all protocol requirements\n\nExclusion Criteria\n\n1. CNS disease- History of CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis, non-autoimmune progressive neurologic condition or PML\n2. Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) or alkaline phosphatase (ALP) detection value is greater than 5 times the upper limit of normal (ULN); or total bilirubin test value greater than 3 times the upper limit of normal (ULN); Exceptional: liver function disturbance due to myositis.\n3. Cardiovascular disease: Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to leukapheresis\u002F moderate- severe pulmonary hypertension\u002F severe arrhythmia (ventricular tachycardia, ventricular fibrillation, high grade ventricular block) in the past 6 months; New York heart function class (NYHA) class III- Level IV or LVEF\\\u003C45%.\n4. Lung disease: patients with chronic lung disease with any of the following: \\* Oxygen saturation (SpO2) \\\u003C 90% on room air \\* FVC≤45% of predicted or DLCO≤40% of predicted at screening. \\* Evidence of pulmonary hypertension as defined as estimated RVSP\\> 50 mmHg.\n5. Muscle disease: evidence of any of the following: \\* Severe proximal muscle atrophy of upper or lower extremity on MRI or clinical examination. \\*Finding of muscular inflammation or myopathy other than the indication, such as inclusion body myositis (IBM), or cancer-associated myositis (myositis diagnosed within 2 years of cancer).\n6. Other uncontrolled diseases: acute diseases (such as acute pneumonia or other infection, pulmonary embolism, diabetic ketoacidosis, acute pancreatitis, etc.) that are clinically unstable or have not been effectively controlled and are not related to indicated autoimmune diseases which in the judgment of the investigator may confound study results or place subjects at undue risk.\n7. Biologics therapy: Received rituximab within 4 months of expected CAR T treatment: No plasma exchange or immunoglobulin treatment within 4 weeks prior to screening. MS patients: No high dose corticosteroid treatment in the 30 days prior to enrollment; see also section 9.1 for the list of restrictions.\n8. Participated in any clinical study within 3 months prior to enrollment, or participate in other clinical investigations during the study period.\n9. Previous or concurrent malignancy with the following exceptions: Adequately treated basal cell or squamous cell carcinoma, in situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening.\n10. Transplantation: History of vital organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002For bone marrow transplantation.\n11. Disease-specific criteria: MS\u002FNMO patients: No disease relapse in the 30 days prior to enrollment\n12. Known HIV positive status.\n13. Active hepatitis B or C infection.\n14. Active CMV infection\n15. Pregnant or lactating women.\n16. Inability to understand or follow the research protocol subject requirements.\n17. Have any other clinically significant disease history or current disease that, in the judgment of the research physician, may pose a risk to the safety of the subjects, or interfere with the completion of the research procedure and the evaluation of safety and efficacy","80 Years",{"count":672,"type":22},120,[25],"A Phase 1 study of HBI0101 BCMA-CART in B-Cell Mediated Autoimmune Rheumatic Diseases. The goal of the study is evaluation of safety and identification of the maximum HBI0101 CART dose that may be administered safely to patients with B-cell mediated autoimmune disease.",[31,676,30,528,677,678,679,653,680],"Idiopathic Inflammatory Myopathy (IIM)","Multiple Sclerosis (MS) Primary Progressive","Multiple Sclerosis (MS) Secondary Progressive","Neuromyelitis Optica Spectrum Disorder (NMOSD)","Antiphospholipid Antibody Syndrome",[682,528,683,684,685,686,687,688,679,653,689],"B-cell mediated autoimmune rheumatic diseases","Systemic sclerosis (SSC)","Idiopathic inflammatory myopathy (IIM)","Rheumatoid arthritis (RA)","B-cell maturation antigen (BCMA)","Autologous CAR-T","Multiple sclerosis (MS) Primary and Secondary progressive","refractory antiphospholipid antibody syndrome","2026-04-29",{"date":692,"type":43},"2026-05-06",{"date":694,"type":43},"2024-09-01",{"date":696,"type":22},"2030-11-01",{"name":698,"class":82},"Polina Stepensky",{"id":700,"slug":701,"hasResults":12,"nctId":702,"briefTitle":703,"officialTitle":703,"acronym":704,"eligibilityCriteria":705,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":706,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":708,"conditions":709,"keywords":710,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":714,"startDateStruct":716,"completionDateStruct":718,"leadSponsor":720,"locationsCount":131},"100587803","prospective-validation-of-a-pharmacological-biomarker-for-low-dose-rituximab-in-rheumatoid-arthritis-100587803","NCT06933134","Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis","PROLOD-RA","Inclusion Criteria:\n\n. Age ≥ 18 years\n\n* Diagnosis of rheumatoid arthritis meeting ACR\u002FEULAR 2010 criteria.\n* Candidates for a Low Dose regimen: on standard dose rituximab and with a good clinical response according to the referring rheumatologist. No maximum duration of use of standard-dose rituximab has been defined.\n* In the case of co-prescription of csDMARDs (Methotrexate, Leflunomide, Salazopyrine, Plaquenil), the dose must have been stable for 3 months.\n* If corticosteroids are co-prescribed, the dose should be ≤ 10 mg\u002Fd and stable for 3 months.\n\nExclusion Criteria:\n\n* Other associated targeted disease-modifying therapy\n* Sjögren's syndrome or other associated inflammatory rheumatism\n* Fibromyalgia or other pathology having an impact on the assessment of disease activity\n* Any active haematological disease affecting lymphocytes (chronic lymphocytic leukaemia, Hodgkin's and non-Hodgkin's lymphomas, lymphoplasmacytic lymphoma, T lymphoma).\n* Opposition to data processing\n* No inclusion of persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g. minors, protected adults, etc.).",{"count":707,"type":22},30,"Evaluation of the prediction of clinical response to rituximab at a dose of 1000 mg once using a pharmacological model including several pharmacokinetic and pharmacodynamic parameters.",[30],[711,601,712,713],"pharmacological biomarker","retreatment","low dose",{"date":715,"type":43},"2026-04-30",{"date":717,"type":43},"2026-04-23",{"date":719,"type":22},"2028-11",{"name":721,"class":82},"University Hospital, Tours"]