[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"polymyalgia-rheumatica-pmr\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:polymyalgia-rheumatica-pmr":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,69,97,118,151,190,219],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100614445","phase-3-justification-and-evaluation-of-baricitinib-plus-corticosteroids-versus-corticosteroids-alone-in-polymyalgia-rheumatica-100614445",false,"NCT07279688","Justification And Evaluation of Baricitinib Plus Corticosteroids Versus corticosteroiDs Alone in pOlymyalgia RhEumatica","Justification And Evaluation of Baricitinib Plus Corticosteroids Versus corticosteroiDs Alone in pOlymyalgia RhEumatica - JADORE-BARI Study","JADORE-BARI","Inclusion Criteria:\n\n* At least 50 years of age.\n* Fulfilling ACR\u002FEULAR classification criteria for PMR newly diagnosed or treatment resistant.\n* No GCs or GCs \\\u003C15 mg\u002Fday since at least 15 days prior to planned randomization.\n* PMR-AS-CRP \\>17.\n* Absence of other inflammatory arthropathy, connective tissue diseases or vasculitis.\n* Able to give informed consent.\n* French health insurance holder\n\nExclusion Criteria:\n\n* Clinical evidence of giant cell arteritis.\n* Uncontrolled high blood pressure or cardiovascular disease.\n* High risk of VTE because of a history of VTE (DVT and\u002For PE) within 12 weeks prior to randomization or a history of recurrent (\\>1) VTE (counting co-occurring DVT+PE as 1 single event).\n* Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR\n* Planned major surgical procedure during the study or medical history, blood abnormalities or any clinical condition that compromises inclusion.\n* Current smoker if age \\>65 years.\n* Current active uncontrolled infection.\n* Treatment by probenecid.\n* Alkaline phosphatase (ALP) ≥2 x ULN.\n* Total bilirubin level (TBL) ≥1.5 x ULN.\n* Neutropenia (absolute neutrophil count \\\u003C1000 cells\u002FuL) (\\\u003C1.00 x 103\u002FuL or \\\u003C1.00 GI\u002FL).\n* Lymphopenia (lymphocyte count \\\u003C500 cells\u002FuL) (\\\u003C0.50 x 103\u002FuL or \\\u003C0.50 GI\u002FL).\n* Patient under court protection or protected adults","ALL","50 Years",{"count":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Polymyalgia rheumatic (PMR) is an inflammatory rheumatic disease affecting the elderly. The diagnosis is based on established ACR\u002FEULAR classification criteria.\n\nThe activity of the disease is evaluated using the PMR-AS, a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment and pain assessment measured by the patient using VAS, and the C-reactive protein (CRP) level. The PMR-AS-CRP (PMR-AS) is considered as relevant to define disease activity (low activity \\\u003C7; moderate activity 7 to 17; high activity \\>17), flare (\\>10), remission (\\\u003C1.5), but also to decide if treatment has to be decreased, unchanged or increased (PMR-AS \\\u003C10: decrease, PMR-AS \\>20 increase, 10≤ PMR-AS ≤20: stable dose) \\[10-12\\].\n\nLong term low-dose glucocorticoid (GCs) (prednisone or prednisolone started at 12.5 to 25 mg\u002Fday progressively tapered) is the mainstay of the treatment. But comorbidities in PMR are due to GCs and 30% of the patients underwent a relapse when tapering GCs.\n\nToday, the physicians do not know what is the best duration and the best dosage of GCs. The international recommendation suggests to start prednisone at a dose between 12.5 to 25 mg, to be at 10 mg at 1 or 2 months, and then to decrease slowly. The treatment is generally ordered for 6-18 months but it is possible to try a shorter treatment duration when patients have been previously treated with GCs or in case of comorbidities.\n\nThe TENOR study, a phase 2 study, demonstrated efficacy of tocilizumab as first line treatment in PMR and its ability to spare GCs. The Semaphore study confirmed the usefulness of tocilizumab in corticodependent forms and demonstrated its efficacy. Another IL-6 inhibitor, sarilumab was authorized for the treatment for polymyalgia rheumatic in adult patients with inadequate response to corticosteroid or relapsing disease but is not reimbursed in France.\n\nBaricitinib is an oral selective JAK inhibitor of JAK1 and JAK2 with a short half-life. There are two dosages available (i.e., 2-mg and 4-mg) which can help conduct a simple dose tapering. Administration of baricitinib resulted in a rapid dose dependent inhibition of IL-6 induced STAT3 phosphorylation. An evaluation could be made using the PMR-AS with and without imputation to minimize the effect of baricitinib on CRP by anti-IL-6 effect.\n\nPreliminary results of the BACHELOR study (34 patients treated with baricitinib or placebo) suggested a great efficacy of baricitinib in early PMR without steroids.\n\nIt could be a treatment of PMR, with low dose or no steroids only during the first month, to minimize the adverse events of steroids. JAK inhibitors have been reevaluated by EMA, the Oral Surveillance study suggesting that tofacitinib (Xeljanz®) increases the risk of major cardiovascular problems, cancer, VTE, serious infections and death due to any cause when compared with medicines belonging to the class of TNF-alpha inhibitors. EMA has concluded that these safety findings apply to all approved uses of JAK inhibitors in chronic inflammatory disorders. Nevertheless, the risk was not increased during the first months of treatment in all studies and a short treatment could have lower risks than steroids.\n\nAs no suitable treatment alternatives are available, excepted GCs which increase the vascular risk and osteoporosis, short treatment by jak inhibitor could be a relevant alternative treatment of PMR. Indeed, the physicians do not have any disease modifying drug (excepted anti IL6 off-label) in treatment of PMR. So, GCs are used for more than one year in the treatment of PMR. Baricitinib, used only 6 months demonstrated its ability to cure early PMR without steroids. It could be an alternative to steroid when physicians consider that ratio benefit\u002Frisk is better with a 6 months treatment by baricitininib than \\>one year by steroids.\n\nOur goal is now to demonstrate in a large cohort the ability of a 6-month treatment with baricitinib in comparison to placebo to decrease glucocorticoids and then to maintain low disease activity without corticosteroids in PMR and a good safety profile.\n\nDue to the possible lower risk of 2 mg than 4 mg of baricitinib, but probably a lower efficacy, the investigators plan to compare both baricitinib (4 mg and 2 mg) to placebo. The study will be conducted in France.",[27],"Polymyalgia Rheumatica (PMR)","RECRUITING","2026-06-09",{"date":31,"type":32},"2026-06-10","ACTUAL",{"date":34,"type":32},"2025-12-18",{"date":36,"type":21},"2029-06",{"name":38,"class":39},"University Hospital, Brest","OTHER",22,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100454119","phase-4-hydrocortisone-and-placebo-in-patients-with-symptoms-of-adrenal-insufficiency-after-cessation-of-glucocorticoid-treatment-100454119","NCT05193396","Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment","A Multi-centre, Randomised, Double-blinded, Placebo Controlled 16-weeks Study to Compare the Effect of Hydrocortisone and Placebo in Patients With Giant Cell Arteritis (GCA)\u002F Polymyalgia Rheumatica (PMR) With Patient-reported Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment.","REPLACE","Inclusion Criteria:\n\n* Age ≥ 50 years\n* A diagnosis of PMR or GCA in GC free remission for \\>2 week and \\\u003C12 weeks after treatment with prednisolone (any dosage) for ≥12 weeks\n\nExclusion Criteria:\n\n* Known primary or secondary adrenal insufficiency\n* Known Cushing´s syndrome\n* Heart failure (New York Heart Association class IV)\n* Kidney failure with an estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\n* Liver cirrhosis\n* Active cancer\n* Known severe immune deficiency\n* A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry)\n* Alcohol consumption \\>21 units per week\n* Planned major surgery during the study period at study entry\n* Use of drugs that interfere with cortisol metabolism\u002Fmeasurements:\n* Systemic oestrogen treatment within 1 month before study inclusion\n* Strong CYP3A4 inhibitors or inducers\n* Use of other glucocorticoid formulations: inhaled, intra-articular or intramuscular injections, creams European steroid group IV applied in genital area\n* Permitted glucocorticoid formulations: eye-drops, nasal spray, creams European group I-III, and European group IV applied in non-genital area\n* Inability to provide written informed consent",{"count":50,"type":21},100,[52],"PHASE4","Cortisol, a glucocorticoid (GC) hormone secreted from the adrenal glands, is essential for survival. Cortisol also possesses anti-inflammatory actions and GC formulations (prednisolone) are used to treat many inflammatory diseases and conditions. Indeed, three percent of the Danish population (≈ 180.000 individuals) redeems at least one prescription of synthetic GC per year and at least 20,000 patients annually discontinue GC treatment. Pharmacological GC therapy suppresses endogenous cortisol production and thereby induce relative adrenal insufficiency (GIA). The risk of GIA as determined by the adrenal corticotrophic hormone (ACTH) stimulation test has previously been reported to ≈ 25 %, but testing after GC treatment is not routinely performed. Indeed, new evidence suggest that the risk of GIA after planned cessation of prednisolone treatment for polymyalgia rheumatic (PMR) or giant cell arteritis (GCA) is substantially lower, probably 2%. The reason for this discrepancy is undoubtedly selection bias in the previous publications and the use of inaccurate cortisol assays. At the same time, however, it was observed that 25% exhibited pronounced symptoms of adrenal insufficiency based on a questionnaire specific for detecting symptoms of adrenal insufficiency, the so-called AddiQoL-30. Concomitantly, the basal cortisol levels in the same group were significantly lower as compared to the group, who exhibited milder or no symptoms attributable to adrenal insufficiency. This observation aligns with the clinical experience that PMR\u002FGCA patients often complain of fatigue after planned cessation of prednisolone treatment. This often occurs in the absence of objective symptoms or signs of residual PMR\u002FGCA disease activity. The scenario has been designated as \"the steroid withdrawal syndrome\". This may represent a state of relative adrenal insufficiency prompted by long term, high dose prednisolone treatment. The proper way to tackle this clinical conundrum is to perform a proper randomized trial, which so far has not been conducted.\n\nTherefore, investigators of this study will perform the first placebo-controlled randomised controlled trial (RCT) in patients with PMR and GCA after planned cessation of GC treatment. Investigators argue that neither watchful waiting nor routine hydrocortisone replacement are infallible. The study will be the first evidence-based guidance and aid to GIA patients and thus meet an important need for many thousand patients.",[55,27,56],"Adrenal Insufficiency","Giant Cell Arteritis (GCA)",[58],"tertiary adrenal insufficiency","2025-12-15",{"date":61,"type":32},"2025-12-22",{"date":63,"type":32},"2022-02-01",{"date":65,"type":21},"2026-01",{"name":67,"class":39},"Marianne Andersen",3,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100593749","using-novel-imaging-to-rethink-diagnostic-and-treatment-strategies-for-polymyalgia-rheumatica-100593749","NCT07010484","Using Novel Imaging to Rethink Diagnostic and Treatment Strategies for Polymyalgia Rheumatica","REMAP PMR","Inclusion Criteria:\n\n1. Patients suspected of PMR seen at the Department of Rheumatology\u002Finternal medicine in Aarhus, Silkeborg, Horsens, Gødstrup, Randers, and Svendborg.\n2. Age above 50.\n3. Proximal extremity pain.\n\nExclusion Criteria:\n\n1. Oral, intravenous, intra-articular or intramuscular glucocorticoids within the last 2 months.\n2. Previous prednisolone treatment for GCA\u002FPMR.\n3. Unable to give consent.\n4. Proximal extremity pain duration for more than one year.\n5. Symptoms of GCA (headache, scalp tenderness, jaw or tongue claudication, vision disturbances attributable to GCA, limb claudication).\n6. Active malignant cancers within the last 5 years (except basal cell carcinoma).\n7. Other known inflammatory rheumatic diseases (e.g. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritis, gout).\n8. Uncontrolled diseases (e.g. severe active asthma, cardiac disease with NYHA class IV)\n9. For MRI: Implants contraindicating MRI and BMI\\>150 kg.",{"count":77,"type":21},149,"OBSERVATIONAL","Polymyalgia rheumatica (PMR) is the most common chronic inflammatory rheumatic disease among the elderly and is characterized by proximal extremity pain and fatigue. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to avoid unnecessary treatment. However, clinical diagnosis and even imaging such as positron emission tomography and computed tomography (PET\u002FCT) has low diagnostic accuracy, which decrease after start of prednisolone. The purpose is to evaluate a new method to diagnose PMR with PET\u002FCT using magnetic resonance imaging (MRI) for informing the interpretation of PET in 111 patients suspected of PMR at baseline and after 8 weeks prednisolone treatment. In addition, a treatment initiation strategy guided by clinical diagnosis combined with PET will be evaluated in 100 patients with newly diagnosed PMR.",[27],[82,83,84,85,86],"polymyalgia rheumatica","imaging","diagnosis","PET\u002FCT","PET\u002FMRI","2025-09-26",{"date":89,"type":32},"2025-10-01",{"date":91,"type":32},"2025-08-21",{"date":93,"type":21},"2032-08-31",{"name":95,"class":39},"Kresten Krarup Keller",7,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100562938","pilot-study-to-evaluatethrombomodulin-to-rule-out-giant-cell-arteritis-gca-in-polymyalgia-rheumatica-pmr-patients-thropiq-100562938","NCT06609668","Pilot Study to evaluateThrombomodulin to Rule Out Giant Cell Arteritis (GCA) in Polymyalgia Rheumatica (PMR) Patients. (THROPIQ)","THROPIQ","Inclusion Criteria:\n\n* Patient who has given oral consent\n* Patient \\> 50 years of age\n\nPatients with PPR, meeting ACR\u002FEULAR 2012 criteria:\n\n* age \\> 50 years at onset of symptoms\n* inflammatory limb-girdle pain\n* elevated ESR (\\>20 mm\u002Fhr) and\u002For CRP (\\> 10 mg\u002Fl)\n* AND Score ≥ 4 points among\n\n  * Morning stiffness \\> 45 minutes (2 pts)\n  * Hip pain or limitation of amplitude (1 pt)\n  * Rheumatoid factor or anti-CCP antibodies negative (2 pts)\n  * Absence of other joint pain (1 pt)\n\nExclusion Criteria:\n\n* Patient not affiliated to national health insurance\n* Patient under legal protection (curatorship, guardianship)\n* Patient subject to a measure of legal safeguard\n* Pregnant or breast-feeding women\n* Adult patient unable to provide consent\n* Patient having received corticosteroid or immunosuppressive treatment in the month prior to inclusion\n* Patient with a contraindication to corticosteroid therapy\n* Patients with an active infection, neoplasia or other inflammatory\u002Fautoimmune condition\n* Patients with late onset rheumatoid arthritis.\n* Conditions rendering vascular imaging unfeasible or uninterpretable:\n* For angio-CT: allergy to iodine, renal failure (CKD \\\u003C30 mL\u002Fmin)\n* For PET scan: unbalanced diabetes NB: only one of the two vascular imaging techniques will be performed, depending on the patient\\'s condition and the technical resources available.\n\nSecondary exclusion criteria:\n\n* Final diagnosis of paraneoplastic PMR\n* Final diagnosis of RA\n* Negative PET scan (if performed 72 hours after glucocorticoid introduction)",{"count":105,"type":21},78,"Polymyalgia rheumatica (PMR) is a rheumatologic condition occurring in patients \\> 50 years old, characterized by inflammatory pain of the scapular (shoulder) and pelvic (hip) girdles. PMR is most often isolated but can be associated with giant cell arteritis (GCA), a large vessels vasculitis, in 16 to 21% of case. The main features of GCA are headaches, jaw claudication, visual disturbances, abnormal temporal artery, scalp tenderness associated to elevated CRP and\u002For ESR. However, GCA could be asymptomatic in particular in case of isolated involvement of large vessels (subclinical GCA).\n\nGCA requires high doses of glucocorticoids, compared to isolated PMR, to avoid complications resulting from vascular remodeling (stroke, blindness). Ruling out GCA in PMR patients relies on the performance of some complementary exams that explore cranial vessels as color doppler ultrasound and\u002For temporal artery biopsy and large vessels that relies on PET\u002FFDG or angio CT scan.\n\nThe aim of this study is to identifie serum biomarkers that could rule out or identifies GCA in patients with PMR features. Ultimately, if biomarkers are identified, this could allow to select PMR patients in whom complementary exams are needed or not. For this study, investigators chose to explore thrombomodulin. Thrombomodulin is a protein that is increased in the circulating blood during vascular inflammation, and therefore seems to be a good candidate for distinguish isolated PMR from PMR associated with GCA.",[56,27],"2025-09-02",{"date":110,"type":32},"2025-09-09",{"date":112,"type":32},"2024-10-10",{"date":114,"type":21},"2027-10",{"name":116,"class":39},"Centre Hospitalier Universitaire Dijon",1,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":126,"sex":17,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":117},"100604475","clinical-assessment-for-rheumatologic-disease---research-and-advancement-in-safety-and-efficacy-100604475","NCT07150000","Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE","Inclusion Criteria:\n\n* Participants aged ≥ 18 years\n* Signed written informed consent to participate voluntarily in the study.\n* Confirmed diagnosis (by the treating physician) of one of the following autoimmune or autoinflammatory rheumatic diseases:\n* Rheumatoid arthritis (RA)\n* Psoriatic arthritis (PsA)\n* Axial spondyloarthritis (axSpA)\n* Giant cell arteritis (GCA)\n* Connective tissue diseases, including:\n\n  1. Systemic lupus erythematosus (SLE)\n  2. Systemic sclerosis (SSc)\n  3. Mixed connective tissue disease (MCTD)\n  4. Idiopathic inflammatory myopathies (IIM)\n* ANCA-associated vasculitides (AAV), including:\n\n  1. Microscopic polyangiitis (MPA)\n  2. Granulomatosis with polyangiitis (GPA)\n  3. Eosinophilic granulomatosis with polyangiitis (EGPA)\n* Autoinflammatory diseases, including\n\n  1. Familial Mediterranean fever (FMF)\n  2. Cryopyrin-associated periodic syndromes (CAPS)\n  3. TNF receptor-associated periodic syndrome (TRAPS)\n  4. Adult-onset Still's disease (AOSD)\n\n     Exclusion Criteria:\n* Refusal to participate in the study or inability to provide informed consent.\n\nInclusion Criteria - Healthy Control Group:\n\n* Participants aged ≥ 18 years (capable of providing informed consent).\n* Signed written informed consent to participate voluntarily in the study.\n\nExclusion Criteria - Healthy Control Group:\n\n\\- Presence of a known or active rheumatologic disease.",true,"18 Years",{"count":129,"type":21},120,"The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases. The primary objective is the development and implementation of an innovative cell-based ex vivo assay that enables individualized prediction of therapeutic response to disease-modifying antirheumatic drugs (DMARDs). By identifying the most effective treatment option for each patient, this approach seeks to enhance therapeutic efficacy, reduce time to clinical response, and minimize healthcare costs.\n\nDespite the availability of numerous DMARDs, clinical decision-making remains largely empirical due to considerable interindividual variability in treatment response. This frequently results in a prolonged trial-and-error process, placing a significant burden on patients and the healthcare system. CARe RAiSE aims to overcome this limitation by providing a functional diagnostic tool that can predict a patient's immunological response to specific DMARDs prior to treatment initiation.\n\nThe assay is based on peripheral blood mononuclear cells (PBMCs) obtained from individual patients, enabling a physiologically relevant assessment of immune responsiveness to targeted therapies. Combining high-content imaging with homogeneous well-based cytokine and inflammasome activity assays, the platform allows for a detailed single-cell analysis of inflammatory pathways. These data are used to generate predictive signatures of treatment response, thereby facilitating a mechanistically informed and personalized therapeutic strategy.\n\nThrough this approach, CARe RAiSE introduces a scientifically grounded, efficient, and patient-specific method for DMARD selection, with the potential to substantially improve patient outcomes and reduce the socioeconomic impact of autoimmune rheumatic diseases.",[132,133,56,134,135,27,136,137,138,139,140,141,142],"Rheumatic Diseases","Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)","Axial Spondylarthritis (axSpA)","ANCA Associated Vasculitis (AAV)","Connective Tissue Disease (CTD)","Systemic Sclerosis (SSc)","Systemic Lupus Erthematosus (SLE)","Idiopathic Inflammatory Myopathy (IIM)","Autoinflammatory Disease","Gout Arthritis","2025-08-24",{"date":108,"type":32},{"date":146,"type":32},"2025-04-01",{"date":148,"type":21},"2028-12",{"name":150,"class":39},"University of Bonn",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":126,"sex":159,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":162,"conditions":163,"keywords":172,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":117},"100569575","aylo---autoimmunity-and-loss-of-y-100569575","NCT06696027","AYLo - AutoimmunitY and Loss of y","Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases","AYLo","Inclusion Criteria:\n\n* Male\n* \\> 50 years\n* Diagnosis of arthritis (RA, PsA), collagen diseases (SLE, systemic sclerosis, Sjögren's syndrome, mixed connective tissue diseases), vasculitis (eGPA, GPA, MPA, IgG4-related disease, GCA, PMR), sarcoidosis, COPD, ILD or asthma bronchiale confirmed by the treating physician.\n\nExclusion Criteria:\n\n* Female\n* \\\u003C 50 years\n\nInclusion Criteria (Healthy controls):\n\n* Male\n* \\> 50 years\n\nExclusion Criteria (Healthy controls):\n\n* Female\n* \\\u003C 50 years\n* autoimmune, rheumatological diease\n* pulmonary precondition","MALE",{"count":161,"type":21},500,"The AYLo study (AutoimmunitY and Loss of y - Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases) aims to systematically investigate hematopoietic mutations, such as hematopoietic (mosaic) loss of the Y chromosome (mLOY), focusing on their underlying causes, pathophysiological significance, patterns of manifestation, and impact on disease progression in autoimmune, rheumatologic disorders. This research seeks to bridge existing knowledge gaps by exploring how such mutations influence immune homeostasis, cellular function, and susceptibility to inflammation-driven pathologies.\n\nThrough the integration of advanced immunological profiling, the study aspires to uncover key mechanisms that drive the initiation, progression, and complications of autoimmune rheumatic diseases. These analyses will combine single nucleotide polymorphisms (SNP) arrays, multiplex assays, transcriptomics, and flow cytometry staining of peripheral blood mononuclear cells to delineate the interplay between hematopoietic mutations and immune dysregulation.\n\nA further objective is the development of a multimodal framework for disease-specific characterization, enabling precise mapping of mutation-driven phenotypes across diverse autoimmune conditions. This framework will incorporate clinical, molecular, and imaging data.\n\nAdditionally, the AYLo study aims to explore the potential role of mLOY and other hematopoietic mutations as biomarkers for disease stratification, prognosis, and therapeutic response. The findings may open avenues for personalized treatment approaches, leveraging the molecular insights to inform targeted interventions and improve patient outcomes in autoimmune rheumatic disorders.\n\nBy integrating translational and basic science approaches, this study has the potential to redefine current paradigms in autoimmune disease research and therapy.",[56,27,136,164,165,133,134,166,167,168,169,170,171],"Idiopathic Inflammatory Myopathies","IgG4-Related Diseases","Connective Tissue Disease","Sarcoidosis","Interstitial Lung Disease Due to Systemic Disease (Disorder)","Interstitial Lung Disease (ILD)","Asthma Bronchiale","COPD",[173,174,175,176,177,178,164,165,179,180,166,167,181],"Autoimmune Diseases","Vasculitis","Large Vessel Vasculitis","Giant Cell Arteritis","Polymyalgia Rheumatica","ANCA Associated Vasculitis","Rheumatoid Arthritis","Psoriatic Arthritis","Interstitial Lung Disease","2025-04-07",{"date":184,"type":32},"2025-04-10",{"date":186,"type":32},"2024-11-15",{"date":188,"type":21},"2026-07",{"name":150,"class":39},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":127,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":217,"locationsCount":117},"100476093","predictive-factors-for-treatment-response-in-patients-with-newly-diagnosed-polymyalgia-rheumatica-and-giant-cell-arteritis-100476093","NCT05479448","Predictive Factors for Treatment Response in Patients With Newly-diagnosed Polymyalgia Rheumatica and Giant Cell Arteritis","Inclusion Criteria:\n\n* Patients with diagnosis of PMR according to the 2012 provisional classification criteria and GCA according to published criteria\n* Consent to participate in the SCQM database\n* Treatment according to our standardized regimes\n\nExclusion Criteria:\n\n* Treatment with Tocilizumab, MTX or other disease modifying medications at inclusion\n* History of GCA and PMR in the past\n* Inability to give informed consent",{"count":197,"type":21},30,"This prospective study is to explore different predictive factors for response to steroid treatment in patients with PMR and\u002For GCA. It evaluates the association of endogenous GC suppression (plasma and urinary cortisol and cortisone) to the responsiveness of PMR\u002FGCA to GCs.",[27,56],[201,202,203,204,205,206,207,208,209,210,211],"Large vessel vasculitis (LVV)","Glucocorticoid receptor (GCR)","glucocorticoid (GC)","steroid-response","GCR expression levels","GCR sensitivity\u002Fresponsiveness","prednisolone","prednisone","Swiss Clinical Quality Management in Rheumatic Diseases (SCQM)","Glucocorticoid resistance","endogenous GC suppression","2025-03-31",{"date":146,"type":32},{"date":215,"type":32},"2022-06-03",{"date":148,"type":21},{"name":218,"class":39},"University Hospital, Basel, Switzerland",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":127,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":236,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":117},"100574997","a-registry-study-assessing-pro-dosing-patterns-and-safety-of-vunakizumab-in-patients-with-general-rheumatic-diseases-100574997","NCT06766552","A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.","A Multicenter Registry Study Assessing Patient Reported Outcome, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.","V-MIRACLE","Inclusion Criteria:\n\n1. Diagnosed with rheumatic autoimmune diseases such as ankylosing spondylitis\u002Fradiologically negative axial spondyloarthritis\u002Fpsoriatic arthritis\u002Fpolymyalgia rheumatica\u002FTakayasu arteritis\u002Fgiant cell arteritis\u002F non-ocular Behcet's disease\u002F enthesitis-related arthritis;\n2. Currently receiving or planning to receive fulvezinib treatment;\n3. Can follow up according to the doctor's advice;\n4. Able to understand and sign the informed consent form, understand the purpose of this study, and voluntarily participate in this study.\n\nExclusion Criteria:\n\n1.Investigator believes will prevent the subject from following and completing the study protocol",{"count":228,"type":21},10000,"Ankylosing spondylitis, radiographically negative axial spondyloarthritis, psoriatic arthritis, polymyalgia rheumatica, Takayasu arteritis, giant cell arteritis, non-ocular Behcet's disease, and enthesitis-related arthritis are common diseases in rheumatology. Traditional anti-rheumatic drugs are less effective and have greater side effects than biological agents. At present, there has been no large-scale registration study on rheumatic autoimmune diseases such as spondyloarthritis in China. However, data such as patient characteristics, medication patterns, and patient outcome reports of different rheumatology diseases can often serve as a reference for rheumatology clinicians to reasonably select treatment methods for different patients. Therefore, a large-scale registration study is needed to fill the gap in multi-disease registration studies in rheumatology departments in China.",[231,134,232,27,233,56,234,235],"Ankylosing Spondylitis (AS)","Nr-axSpA","Takayasu Arteritis (TAK)","Behcet's Disease","Enthesitis-related Arthritis","NOT_YET_RECRUITING","2025-01-08",{"date":239,"type":32},"2025-01-09",{"date":241,"type":21},"2025-01-30",{"date":243,"type":21},"2030-06-30",{"name":245,"class":39},"Second Affiliated Hospital, School of Medicine, Zhejiang University"]