[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"giant-cell-arteritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:giant-cell-arteritis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,48,80,106,130,158,189,228,264,301,322,343,370,396,419,454,489,511,545,565,586,613],{"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":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100363491","phase-3-giant-cell-arteritis-comparison-between-two-standardized-corticosteroids-tapering-100363491",false,"NCT04012905","Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering","A Randomized, Controled, Open Label Trial: Comparison Between Two Standardized Corticosteroids Tapering, Respectively Short (North American) and Long (European), in Giant Cell Arteritis","CORTODOSE","Inclusion Criteria:\n\n* Age ≥ 50 years\n* Patient with temporal arteritis giant cell match 2 of the 4 criteria of the American College of Rheumatology (ACR) that given :\n\n  * a temporal artery biopsy compatible with a diagnosis of CAG or\n  * an abdominal thoracic aortitis diagnosed by Angio CT, MR angiography or PET scanner or\n  * Echo Doppler compatible with a diagnosis of CAG\n* Oral corticosteroid treatment started up to 14 days, the initial dose is less or equal to 1 mg \u002F Kg\n* Patient wo has given its written consent Patient affiliated with a social security\n\nExclusion Criteria:\n\nSubjects checking one of the criteria for non-inclusion may be eligible to participate in the research. These criteria may include:\n\n* Early treatment of CAG disease with a dose\\> 1 mg \u002F kg whatever the duration\n* Corticosteroids already started over 14 days\n* Giant arteritis cell on relapse\n* dementia syndrome\n* No compliant patient\n* Patients who live more than 150 km from the investigation center\n* Person under judicial protection, guardianship\n* Hypersensitivity to prednisone or any of its excipients\n* Infection requiring an systemic treatment\n* Evolutive viroses (Hepatitis, Herpes, varicella-zoster virus)\n* Immunization with live vaccines \u002F mitigated during the 8 weeks preceding inclusion\n* Pregnancy, breastfeeding women or women of childbearing potential not using contraception","ALL","50 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Corticosteroid therapy has always been the standard treatment for giant cell arteritis (GCA), with very good initial clinical efficacy but a high relapse rate when it declines.\n\nThe target population of this condition, often elderly, is particularly exposed to the numerous undesirable effects of corticosteroid therapy, and this especially as its duration lengthens with the re-increases of doses according to relapses: metabolic complications, osteo-muscular , infectious or neuropsychiatric.\n\nInvestigators propose to compare prospectively the results of a \"conventional\" corticosteroid regimen as recommended by European societies, to those of a \"lighter and \u002F or shorter\" scheme, inspired by recent North American trials. , including the largest prospective global study in the field. Investigators hypothesize non-inferiority of the lightened regimen for relapse rate without relapse at S52, but with a decrease in treatment-related adverse events whose cumulative doses should be lower.\n\nInvestigators therefore plan to include prospectively over 3 years 150 patients, 75 for each of the two arms, with a newly diagnosed ACG. A randomization of the treatment arm will be performed and a predefined pattern of cortisone adapted to body weight will be given to the patient. Relapse rates, maintenance of remission, cumulative doses of cortisone and adverse effects of treatment will be analyzed at the 52nd week of the introduction of corticosteroid therapy. An interim analysis is planned at S28.",[27],"Giant Cell Arteritis",[27,29,30,31,32,33,34],"Horton disease","Corticosteroids treatment","Prednisone","Relapse","Side effect","Cumulative doses","RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-26","ACTUAL",{"date":41,"type":39},"2021-03-03",{"date":43,"type":21},"2029-05-03",{"name":45,"class":46},"University Hospital, Caen","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":47},"100228924","studies-of-the-natural-history-pathogenesis-and-outcome-of-idiopathic-systemic-vasculitis-100228924","NCT02257866","Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis","* INCLUSION CRITERIA:\n\nSUBJECTS WITH VASCULITIS\n\n* Subjects who fulfill modified versions of the 1990 American College of Rheumatology (ACR) Classification Criteria for GPA31 and PAN\n* Subjects who fulfill the 1990 ACR Classification Criteria for EGPA, GCA, and TAK\n* Subjects who fulfill the 2012 Chapel Hill Nomenclature definition for MPA\n* Subjects with other suspected systemic or single-organ vasculitides\n\nHEALTHY VOLUNTEERS\n\n-Volunteers able to provide consent, or in the case of minors, assent\n\nEXCLUSION CRITERIA:\n\nSUBJECTS WITH VASCULITIS:\n\n* Subjects less than 3 years of age\n* Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion\n* Inability to provide consent, or in the case of minors, assent\n* Subjects with bleeding diathesis or on anticoagulant medications (e.g. coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participation in nasal brushing or biopsy studies\n\nHEALTHY VOLUNTEERS\n\n* Volunteers less than 3 years of age\n* Diagnosis of vasculitis or other autoimmune\u002Fautoinflamamtory disease, including systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, mixed connective tissue disease or any overlap autoimmune syndrome\n* Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion\n* Pregnant (by history of last menstrual period) or breast feeding subjects\n* Subjects with bleeding diathesis or taking anticoagulant medications (eg coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participating in nasal brushing studies",true,"3 Years",{"count":57,"type":21},4000,"OBSERVATIONAL","Background:\n\n\\- Vasculitis is a group of diseases that inflame and damage blood vessels and tissue. It can cause many medical problems. Few tests can diagnose the disease, and none can reliably predict a relapse. Researchers want to study people s genes and follow people over time to see how the disease affects them.\n\nObjective:\n\n\\- To learn the signs, symptoms, imaging tests, genetic markers, and blood tests that can help identify people with vasculitis and predict what will happen to them over time.\n\nEligibility:\n\n* People age 3 and older who have or are thought to have vasculitis, or are related to someone with it.\n* Healthy volunteers.\n\nDesign:\n\n* Participants will be evaluated by a doctor who has expertise caring for patients with vasculitis.\n* Participants will give a blood sample. Some will give a urine sample.\n* Some participants may have brushings or biopsies taken from the inside lining of the nose.\n* Images of participants blood vessels may be taken using scans. For some scans, participants will lie on a table that moves in and out of a cylinder that takes pictures. For some scans, a contrast agent may be injected into an arm vein. Other scans may use a radioactive form of sugar. Healthy minors will not have scans.\n* Some participants will answer questionnaires. - Some participants will have their tests done at NIH. Others will have their doctor take the blood, saliva, or cheek swab samples and send them to NIH.\n* Some participants will have one visit lasting 1-2 (but sometimes up to 4) days. Some participants may have follow-up visits every 3 - 6 months, indefinitely.",[61,27,62,63,64],"Takayasu's Arteritis","Polyarteritis Nodosa","Relapsing Polychondritis","ANCA-Associated Vasculitis",[62,66,67,63,68,69],"Takayasu's Arthritis","Giant Cell Arthritis","Antineutrophil Cytoplasmic Antibodies","Natural History","2026-06-13",{"date":72,"type":39},"2026-06-16",{"date":74,"type":39},"2014-09-29",{"date":76,"type":21},"2050-01-01",{"name":78,"class":79},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":47},"100541901","phase-2-a-clinical-trial-to-investigate-18f-azafol-in-the-diagnosis-of-large-vessel-vasculitis-100541901","NCT06335888","A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis","Cross-over, Randomized, Open-label, Single-centre, Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis","CRAFT","Inclusion Criteria:\n\n* Individuals ≥ 50 years with clinical suspicion of GCA\n* Women of childbearing potential must not have a positive serum pregnancy test at the Screening Visit\n* Subjects must be able to understand and adhere to all protocol requirements and must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)\u002Finstitutional review board (IRB), prior to the initiation of any screening or study-specific procedures.\n* Are willing and able to comply with procedures required in this protocol.\n\nExclusion Criteria:\n\n1. Folate deficiency\n2. Female subjects who are pregnant, breastfeeding, or considering becoming pregnant during the study or within 30 days after the last dose of study drug\n3. Concomitant treatment with medications that lead to a significant impairment of folic acid levels (methotrexate, pemetrexed, raltitrexed)\n4. Concomitant glucose-containing infusion or parental nutrition within 6 hours prior to 2-\\[18F\\]FDG tracer application\n5. Glucose level \\> 10 mmol\u002Fl at the timepoint of 2-\\[18F\\]FDG PET\u002FCT\n6. Unable to remain in the PET\u002FCT for the duration of the examination\n7. Unable to lie still for the duration of the examination (45 min)\n8. Unable not to eat or drink (except water) for 6 hours prior to 2-\\[18F\\]FDG tracer application\n9. Prior PET-imaging within 60 days before baseline\n10. Intake of vitamin supplements containing \\> 1mg\u002Fday folic acid within 48 h prior to the PET\u002FCT with AzaFol\n11. Known hypersensitivity or allergy to folic acid\n12. Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons\n13. Participation in another study with investigational drug within the 7 days preceding and during the present study.",{"count":89,"type":21},70,[91],"PHASE2","The goal of this open-label clinical trial is to evaluate the efficacy of AzaFol-PET\u002FCT in the diagnosis of GCA (giant cell arteritis), to compare AzaFol- with 2-\\[18F\\]FDG-PET\u002FCT, and to assess the safety and tolerability of AzaFol in subjects with suspicion of GCA.\n\nParticipants will undergo AzaFol-PET\u002FCT imaging at a single timepoint.",[27],[95,96],"Tracer","PET imaging","2026-04-30",{"date":99,"type":39},"2026-05-01",{"date":101,"type":39},"2025-02-03",{"date":103,"type":21},"2029-05",{"name":105,"class":46},"Insel Gruppe AG, University Hospital Bern",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":126,"leadSponsor":128,"locationsCount":47},"100632040","early-temporal-dynamics-of-optic-nerve-sheath-diameter-after-therapy-in-gca-100632040","NCT07508514","Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA","Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis","SONIC-TIME","Inclusion Criteria:\n\n1. Participants must be enrolled in SONIC-GCA and must have:\n\n   * completed the baseline optic nerve sheath ultrasound\n   * confirmed GCA as determined by the baseline standardized GCA assessment in SONIC-GCA.\n2. Exposure to glucocorticoids for ≤ 48 hours and ≤ 160 mg prednisone-equivalent before baseline.\n3. Ability and willingness to provide written informed consent.\n4. Agreement to complete the SONIC-TIME intensive follow-up schedule.\n\nExclusion Criteria:\n\n1\\) Concurrent participation in a blinded interventional pharmaceutical clinical trial.",{"count":115,"type":21},60,"Giant cell arteritis (GCA) is an inflammatory disease of large and medium arteries that can cause irreversible vision loss. Glucocorticoids (GCs) rapidly suppress inflammation, but diagnostic imaging tests such as temporal artery ultrasound or biopsy often become falsely negative within days of treatment. The optic nerve sheath diameter (ONSD), measurable by ocular ultrasound, reflects perineural edema and may serve as a quantitative biomarker of ocular inflammation in GCA.\n\nThe SONIC-TIME study (Early Temporal Dynamics of Optic Nerve Sheath Diameter After Glucocorticoid Therapy in Giant Cell Arteritis) is a single-center, prospective observational substudy embedded within SONIC-GCA (NCT05749094) at Hôpital du Sacré-Cœur de Montréal. It aims to characterize how rapidly ONSD decreases after GC initiation and how this trajectory relates to cumulative GC exposure, intravenous methylprednisolone, and early use of steroid-sparing therapies.\n\nSixty participants with newly diagnosed GCA will undergo serial optic nerve sheath ultrasound, blood tests (CRP, ESR), and when feasible, temporal artery ultrasound over the first two months of therapy (Days 3, 7, 10, 14, 21, 28, and Month 2). No experimental treatments are given; all participants receive standard-of-care therapy.\n\nThe primary objective is to quantify the percent change in mean ONSD from baseline to Day 28. Secondary objectives include modeling ONSD change over time, assessing associations with cumulative steroid dose and inflammatory markers, and estimating the time to normalization below the SONIC-GCA cutoff. Findings will define the optimal imaging window and refine the diagnostic and monitoring role of optic nerve ultrasound in GCA.",[27,118,119,120],"Temporal Arteritis","Optic Nerve Diseases","Diagnosis","NOT_YET_RECRUITING","2026-03-31",{"date":124,"type":39},"2026-04-02",{"date":99,"type":21},{"date":127,"type":21},"2028-05-01",{"name":129,"class":46},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100584841","association-of-ultrasonographic-temporal-artery-lesions-and-relapse-in-patients-with-giant-cell-arteritis-100584841","NCT06894602","Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis","ALERT","Inclusion Criteria:\n\n* Major patient\n* Patients meeting ACR 2022 criteria for giant cell arteritis.\n* No opposition expressed\n\nExclusion Criteria:\n\n* Patients unable to understand the protocol, under guardianship or curatorship.\n* Patients not affiliated to the French Social Security system.","18 Years",{"count":139,"type":21},100,"Ultrasound evaluation of the temporal and axillary arteries is currently well recognized in the field of giant cell arteritis (GCA), a disease primarily affecting medium- and large-caliber vessels. Structural ultrasound abnormalities are now well described in this pathology, but their association with relapse and clinical concordance is unknown. There is currently a follow-up score (the OGUS score) for medium- and large-caliber arteries that could also predict the clinical course of the disease.",[27],[143,144,145,146,147],"giant cell arteritis","Ultrasound","follow up","monitoring","OGUS score","2026-03-18",{"date":150,"type":39},"2026-03-20",{"date":152,"type":39},"2025-08-05",{"date":154,"type":21},"2028-08-01",{"name":156,"class":46},"University Hospital, Brest",2,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":170,"conditions":171,"keywords":174,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100472738","phase-4-effect-of-supplemental-hydrocortisone-during-stress-in-prednisolone-induced-adrenal-insufficiency-100472738","NCT05435781","Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency","RESCUE - Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency; A Multicentre, Randomised, Double Blinded, Placebo-controlled Clinical Trial on Health-related Quality of Life in Patients With Polymyalgia Rheumatica\u002FGiant Cell Arteritis Receiving Ongoing Low-dose Prednisolone Treatment.","RESCUE","Inclusion Criteria:\n\n* Age ≥ 50 years\n* Women must be postmenopausal (FSH is measured at the screening visit)\n* A diagnosis of PMR\u002FGCA, or both conditions combined.\n* Treatment with prednisolone ≥12 weeks\n* Ongoing prednisolone treatment, with current daily prednisolone dose \\> 0 mg and ≤5 mg. The dose must have been ≤5 mg for minimum 2 weeks at the time of the screening visit.\n\nExclusion Criteria:\n\n* Known primary or secondary adrenal insufficiency\n* Known Cushing's Syndrome\n* Known allergy towards study medication ingredients\n* Severe comorbidity: Heart failure (New York Heart Association class IV); Kidney failure with an estimated glomerular filtration rate \\\u003C30 mL\u002Fmin (Chronic kidney disease stage 4-5); Liver disease in the form of cirrhosis; Active cancer; Known severe immune deficiency; 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: Systemic oestrogen treatment (discontinued \\\u003C 1 month before inclusion), Treatment with strong CYP3A4 inhibitors or inducers, Use of other glucocorticoid formulations (Inhaled corticosteroids, intraarticular or intramuscular injections, steroid creams European steroid group IV-V used in the genital area. Note: Permitted glucocorticoid formulations: Eye-drops, nasal spray, glucocorticoid creams European steroid group I-III, and European steroid group IV-V used in the non-genital area only.)\n* Inability to provide written informed consent.",{"count":167,"type":21},250,[169],"PHASE4","In this double-blinded randomised placebo-controlled clinical trial, the aim is to determine the effect of supplemental hydrocortisone compared with placebo during mild to moderate physical or mental stress on health related quality of life in patients with polymyalgia rheumatica (PMR)\u002Fgiant cell arteritis (GCA) on ongoing low-dose prednisolone diagnosed with glucocorticoid-induced adrenal insufficiency. The main emphasis is on fatigue (primary outcome) and daily variation hereof during periods of stress.",[172,173,27],"Adrenal Insufficiency","Polymyalgia Rheumatica",[175,176,177,178],"Glucocorticoid-induced adrenal insufficiency","Prednisolone","Glucocorticoids","Hypothalamic-pituitary-adrenal axis","2026-03-12",{"date":181,"type":39},"2026-03-16",{"date":183,"type":39},"2022-06-07",{"date":185,"type":21},"2028-03-01",{"name":187,"class":46},"Marianne Christina Klose",3,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":54,"sex":17,"minAge":137,"maxAge":195,"enrollmentInfo":196,"targetDuration":198,"studyType":58,"phases":4,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":47},"100393366","rheumatology-patient-registry-and-biorepository-100393366","NCT04402086","Rheumatology Patient Registry and Biorepository","Inclusion Criteria for Rheumatology Patients:\n\n* Patients ≥18 years old with a diagnosis of a rheumatic autoimmune disease including, but not limited to: adult onset Still's disease, ankylosing spondylitis, antiphospholipid syndrome, Behcet's disease, dermatomyositis, giant cell arteritis, mixed connective tissue disease, polymyalgia rheumatica, polymyositis, psoriatic arthritis, reactive arthritis, rheumatoid arthritis, sarcoidosis, scleroderma, Sjogren's syndrome, systemic lupus erythematosus, undifferentiated connective tissue disease and vasculitis.\n* Receiving clinical care at Yale Rheumatology clinics\n\nExclusion Criteria for Rheumatology Patients:\n\n* Unable to provide informed consent\n* No patients will be excluded based on gender or ethnicity or pregnancy status.\n* Women who are currently pregnant will need to wait to donate a skin biopsy until after they deliver.\n* Patients allergic to lidocaine or epinephrine or have a history of impaired wound healing will not be able to donate a skin biopsy.\n\nInclusion Criteria for Healthy Volunteers:\n\n* Age ≥ 18 years old\n* No chronic skin conditions\n* No diagnosis of a rheumatic autoimmune disease (e.g., lupus, rheumatoid arthritis)\n* Normal BMI\n\nExclusion Criteria for Healthy Volunteers:\n\n* Unable to provide informed consent.\n* Currently pregnant or nursing unless the study goal is to study pregnant or nursing woman.\n* Allergies to lidocaine or epinephrine (skin biopsies).\n* A history of impaired wound healing (skin biopsies).","99 Years",{"count":197,"type":21},5000,"10 Years","To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.",[201,202,203,204,205,206,207,208,209,210,27,211,212,173,213,214,215,216,217,218],"Rheumatic Diseases","Adult Onset Still Disease","Ankylosing Spondylitis","Psoriatic Arthritis","Reactive Arthritis","Antiphospholipid Syndrome","Systemic Lupus Erythematosus","Behcet Disease","Dermatomyositis","Polymyositis","Lyme Disease","Mixed Connective Tissue Disease","Rheumatoid Arthritis","Sarcoidosis","Systemic Sclerosis","Scleroderma","Sjogren's Syndrome","Undifferentiated Connective Tissue Diseases","2026-02-11",{"date":221,"type":39},"2026-02-13",{"date":223,"type":39},"2020-08-04",{"date":225,"type":21},"2030-06-01",{"name":227,"class":46},"Yale University",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":263},"100398952","phase-3-abatacept-for-the-treatment-of-giant-cell-arteritis-100398952","NCT04474847","Abatacept for the Treatment of Giant Cell Arteritis","A Randomized Double-Blind, Placebo Controlled Trial of Abatacept (CTLA4-Ig) in Giant Cell Arteritis (ABAGART)","Inclusion Criteria:\n\n1. A diagnosis of newly diagnosed or relapsing GCA. Diagnostic criteria for GCA\n\n   A patient will be said to have GCA by meeting 3 of 5 of the following modified ACR criteria for the classification of GCA in which 1 of the 3 must consist of criteria 4 or 5:\n   1. Age at disease onset ≥ 50 years.\n   2. New onset or new type of localized pain in the head.\n   3. ESR of \\> 40 mm in the first hour by the Westergren method or CRP measurement above the laboratory normal limit.\n   4. Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries).\n   5. Temporal artery or large vessel biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cell or an abnormal temporal artery ultrasound showing features consistent with active giant cell arteritis (\"halo sign\") or characteristic changes of large vessel stenosis or aneurysm by arteriography.\n2. GCA with evidence of active disease (defined below) present within the past 8 weeks.\n3. They must be willing and able to comply with treatment and follow-up procedures.\n4. Both women and men who are of child-bearing potential must be willing to use an effective means of birth control while receiving treatment through this study. Effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or hormonal contraception.\n5. They must be willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Evidence of a recent acute infection defined as:\n\n   * Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics.\n   * Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy.\n2. Patients with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.).\n3. Patients with a history of recurrent herpes zoster (more than 1 episode) or disseminated (more than 1 dermatome) herpes zoster or disseminated herpes simplex, or ophthalmic zoster. Symptoms of herpes zoster or herpes simplex must have resolved more than 60 days prior to screening.\n4. Patients with a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis).\n5. Patients with a history of primary immunodeficiency.\n6. Patients at risk for tuberculosis (TB) defined as follows:\n\n   * Current clinical, radiographic or laboratory evidence of active TB, even if currently being treated. Chest x-rays (posterior\u002Fanterior and lateral) obtained within the 6 months prior to screening and TB testing (IFN-gamma release assay or PPD) performed in the past month prior to screening will be accepted; however, a copy of the reports must be placed in the participant binder.\n   * A history of active TB unless there is documentation that the patient had received prior anti-TB treatment that was appropriate in duration and type according to local health authority guidelines.\n   * Patients with a positive TB screening test indicative of latent TB will not be eligible for the study unless they:\n\n     i. Have no evidence of current TB based on chest x-ray performed during the screening period and by history and physical exam, and ii. They are currently being treated for latent TB or the site has documentation of successful prior treatment of latent TB. Treatment regimens should be dictated by local guidelines as long as the treatment dose and duration meet or exceed local health authority guidelines. If permitted by local guidelines regarding treatment with biologic medications, patients with latent TB may be randomized prior to completion of treatment as long as they have completed at least 4 weeks of treatment and they have no evidence of current TB on chest x-ray at screening.\n7. Patients who are pregnant or who are nursing infants.\n8. Inability to comply with study guidelines.\n9. Cytopenia: platelet count \\\u003C80,000\u002Fmm3, total White Blood Count (WBC) \\\u003C 3,000\u002Fmm3 (3 x 109\u002FL) absolute neutrophil \\\u003C1500\u002Fmm3, hematocrit \\\u003C 20%.\n10. Renal insufficiency defined by a creatinine clearance of less than or equal to 20 ml\u002Fmin.\n11. AST or ALT \\> 3 times above normal laboratory range.\n12. Other severe, progressive, or uncontrolled disease that in the investigator's opinion could prevent a patient from fulfilling the study requirements or that would increase the risk of study participation.\n13. Patients who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Patients who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.\n14. Receipt of an investigational agent or device within 30 days prior to enrollment.\n15. A live vaccination within 3 months before randomization.\n16. Patients on non-biologic immunosuppressants must discontinue these medications before randomization (azathioprine, mycophenolate mofetil, mycophenolic acid, leflunomide, hydroxychloroquine, cyclosporin, tacrolimus, or other conventional immunosuppressive agent).\n17. Patients who had received an alkylating agent such as cyclophosphamide must discontinue these medications at least 8 weeks before randomization.\n18. Patients who have been treated within 4 weeks of randomization with etanercept or within 8 weeks with adalimumab, certolizumab, golimumab, or infliximab.\n19. Patients who have been treated within 8 weeks of randomization with anti-IL-6 agents (e.g., tocilizumab, sirukumab) or a janus kinase inhibitor.\n20. Patients who have been treated within 4 weeks of randomization with anakinra.\n21. Patients who have received prior treatment with rituximab within the past 6 months prior to randomization.\n22. Patients who have received prior treatment with abatacept or CTLA4-Ig.\n23. Patients who will require oral or IV glucocorticoid treatment during the trial for conditions other than GCA.\n24. Hypersensitivity to abatacept and\u002For its excipients.\n25. Presence of any of the following disease processes:\n\n    * Takayasu arteritis\n    * Granulomatosis with polyangiitis\n    * Microscopic polyangiitis\n    * Eosinophilic granulomatosis with polyangiitis (Churg-Strauss)\n    * Polyarteritis nodosa\n    * Cogan's syndrome\n    * Behçet's disease\n    * Sarcoidosis\n    * Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics vasculitis\n    * Cryoglobulinemic vasculitis\n    * Systemic lupus erythematosus\n    * Rheumatoid arthritis\n    * Mixed connective tissue disease or any overlap autoimmune syndrome",{"count":236,"type":21},78,[24],"This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abatacept 125mg\u002Fweek or placebo. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept\u002Fplacebo will be stopped.\n\nPatients who do not achieve remission by Month 3, who experience a relapse within the first 12 months will have the option of receiving open-label abatacept for a maximum of 12 months.",[27],[241,242,118,243,244,245,246,247,31,177,248,249,250,251,252,253],"Vasculitis","Arteritis","Abatacept","CTLA4-Ig","Autoimmune Diseases","Immune System Diseases","Immunosuppressive agent","Corticosteroids","Treatment","Pharmacologic Actions","Therapeutic Uses","Anti Inflammatory Agents","Antirheumatic Agents","2026-01-21",{"date":256,"type":39},"2026-01-23",{"date":258,"type":39},"2021-03-29",{"date":260,"type":21},"2029-12",{"name":262,"class":46},"University of Pennsylvania",9,{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":273,"conditions":274,"keywords":284,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":300},"100283245","vcrc-tissue-repository-100283245","NCT02967068","VCRC Tissue Repository","VCRC Tissue Biorepository Collection Protocol","Inclusion Criteria:\n\n* A participant will be deemed eligible for this study if the participant is\u002Fwas enrolled in another one of the VCRC observational\u002Flongitudinal protocols (5502, 5503, 5504, 5505, 5506, 5507, 5563) and\u002For one of the VCRC interventional studies (5522, 5523, 5526, 5527, or 5562).\n\nExclusion Criteria:\n\n* Inability to give informed consent (or their guardians in the case of children) and to sign the consent form.\n* Unwilling to allow the use of their tissue for research.",{"count":272,"type":21},1000,"The purpose of this study is to collect existing tissue specimens from subjects enrolled in Vasculitis Clinical Research Consortium (VCRC) studies. Analysis of these tissue specimens and linked clinical data collected through VCRC studies may lead to the identification and development of a series of translational research projects. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.",[275,276,277,27,278,279,280,281,62,282,283],"Aortitis","Cutaneous Vasculitis","Eosinophilic Granulomatosis With Polyangiitis","Granulomatosis With Polyangiitis (Wegener's)","Henoch-Schonlein Purpura","IgA Vasculitis","Microscopic Polyangiitis","Takayasu Arteritis","Churg-Strauss Syndrome",[285,286,287,288,289,290,291,292],"CSS","EGPA","GCA","GPA","MPA","PAN","TAK","HSP",{"date":294,"type":39},"2026-01-22",{"date":296,"type":39},"2016-11",{"date":298,"type":21},"2028-12",{"name":262,"class":46},8,{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":17,"minAge":308,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":321},"100151303","one-time-dna-study-for-vasculitis-100151303","NCT01241305","One-Time DNA Study for Vasculitis","VCRC Genetic Repository One-Time DNA Protocol","Inclusion Criteria:\n\n1\\. Diagnostic criteria for Giant Cell Arteritis Age at disease onset \\>50 years (required)\n\n1. New onset or new type of localized pain in the head\n2. Temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries)\n3. ESR of \\>40mm in the first hour by the Westergren method\n4. Abnormal artery biopsy (i.e. temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells)\n5. Large Vessel Vasculitis (LVV) by angiogram or biopsy not explained by something else\n\nInclusion Criteria:\n\n2\\. Diagnostic criteria for Takayasu's Arteritis\n\n1. Age at disease onset \\\u003C50 years\n2. Claudication of extremities\n3. Decreased brachial artery pulse (one or both arteries)\n4. Blood pressure difference of \\>10mm Hg between the arms\n5. Bruit over subclavian arteries or aorta\n6. Arteriogram abnormalities compatible with TAK (includes conventional dye angiography or MR angiography or CT angiography)\n\nInclusion Criteria:\n\n3\\. Diagnostic criteria for Polyarteritis Nodosa Major criteria (not explained by other causes) felt by investigator to be due to vasculitis\n\n1. Arteriographic abnormality\n2. Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy\n3. Mononeuropathy or polyneuropathy\n\nMinor criteria (not explained by other causes) felt by investigator to be due to vasculitis\n\n1. Weight loss \\> 4 kg\n2. Livedo reticularis, cutaneous ulcerations, or skin nodules\n3. Testicular pain or tenderness\n4. Myalgias\n5. Diastolic blood pressure \\> 90 mm Hg\n6. Elevated BUN or serum creatinine levels\n7. Ischemic abdominal pain\n\nIsolated cutaneous Polyarteritis Nodosa 1. Biopsy-proven cutaneous PAN\n\nInclusion Criteria:\n\n4\\. Diagnostic criteria for Granulomatosis with Polyangiitis (Wegener's) (GPA) and Microscopic Polyangitis (MPA)\n\n* Diagnosis of GPA or MPA. Widely accepted diagnostic criteria, as opposed to classification criteria or definitions, have not been developed for GPA \\& MPA.\n* For diagnosis of GPA meets at least 2 of the following 5 modified ACR criteria:\n\n  1. Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood\n  2. Abnormal chest radiograph with nodules, fixed infiltrates, or cavities\n  3. Urinary sediment with microhematuria or red cell casts\n  4. Granulomatous inflammation within the wall of an artery or in the perivascular area on biopsy\n  5. Antineutrophil cytoplasmic antibody (ANCA) positive by enzyme immunoassay for either PR3- or MPO-ANCA\n* For diagnosis of MPA, meets the Chapel Hill Consensus Conference Definition for MPA:\n\n  1. Necrotizing vasculitis, with few or no immune deposits, that affects small vessels (i.e., capillaries, venules, arterioles)\n  2. Necrotizing arteritis involving small- and medium-sized arteries may be present\n  3. Necrotizing glomerulonephritis is very common\n  4. Pulmonary capillaritis often occurs\n\n     Inclusion Criteria:\n\n     5\\. Diagnostic criteria for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss)\n     1. Asthma\n     2. Peak peripheral blood eosinophilia of \\>10% of total WBC\n     3. Peripheral neuropathy attributable to vasculitis\n     4. Transient pulmonary infiltrates on chest imaging studies\n     5. Paranasal sinus abnormalities or nasal polyposis\n     6. Eosinophilic inflammation on tissue biopsy\n\n     If patients have 4 of the above 6 criteria but lack clearcut documentation of small vessel vasculitis, they are also eligible for enrollment.\n\n     General Exclusion Criteria:\n* Inability to give informed consent and to sign the consent form\n* Enrolled in VCRC protocols 5502, 5503, 5504, 5505, 5506, 5522, or 5523\n* Unwilling to provide blood for DNA collection","7 Years",{"count":272,"type":21},"The purpose of this study is to identify genes that increase the risk of developing vasculitis, a group of severe diseases that feature inflammation of blood vessels. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.",[312,27,278,281,62,61],"Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)",[241,285,286,287,288,314,289,290,291],"WG",{"date":294,"type":39},{"date":317,"type":4},"2010-10",{"date":319,"type":21},"2028-08",{"name":262,"class":46},14,{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":47},"100504945","impact-of-the-spatial-resolution-of-several-contrast-enhanced-3d-t1-wi-sequences-when-diagnosing-giant-cell-arteritis-gca-100504945","NCT05854927","Impact of the Spatial Resolution of Several Contrast-enhanced 3D T1-WI Sequences When Diagnosing Giant Cell Arteritis (GCA)","SPARTA","Inclusion Criteria:\n\n* Patient over 18 years of age\n* Referred for imaging for an injected MRI for suspected GCA\n* Suspicion of GCA based on the presence of three major criteria or two major and one minor criteria defined as follows:\n\n  * Major criteria: Age \\> 50 years; Headache of recent onset; Claudication of the jaw, tongue or swallowing disorders; Visual problems (blindness, diplopia, blurred vision - including visual accidents occurring during the first week of treatment); Sedimentation rate at 1st hour \\> 50 and\u002For CRP \\> 8mg\u002Fl\n  * Minor criteria: Hypersensitivity or induration of the scalp or presence of nodules remote from the temporal artery; Temporal artery abnormalities on palpation; Facial pain or feeling of facial edema; General signs (fever \\>38°C, weight loss \\>10%, anorexia, malaise, asthenia).\n* Cconsent to participate in the study\n* Affiliated or beneficiary of a social security plan\n\nExclusion Criteria:\n\n* Newly diagnosed malignant disease (diagnosed less than one year prior to inclusion)\n* Active infectious disease\n* Autoimmune disease (especially but not limited to: Wegener's disease, Takayasu vasculitis, ANCA vasculitis, rheumatoid arthritis, lupus erythematosus, periarteritis nodosa).\n* Systemic corticosteroid therapy for more than 10 days at high dose (\\>0.5mg\u002Fkg\u002Fd of prednisone)\n* Contraindication to MRI\n* Patient benefiting from a legal protection measure\n* Pregnant or breastfeeding woman",{"count":330,"type":21},133,"Giant cell arteritis (GCA) (or Horton's disease) is a segmental and focal inflammatory arteritis affecting large and medium-sized arteries. Its incidence is estimated at 17.8\u002F100,000 in subjects over 50 years old (and 46\u002F100,000 in subjects over 70 years old). This disease remains a severe pathology due in particular to its vascular, ophthalmological, neurological, cardiac and aortic complications. In case of suspected CAG, management is a real therapeutic emergency. Indeed, only corticosteroid therapy started as early as possible can prevent the occurrence of these complications.\n\nThe gold standard for the diagnosis of CAG has long been the temporal artery biopsy, but imaging is now considered as a 1st line diagnostic examination for the diagnosis of CAG according to the EULAR 2018 recommendations. Notably, temporal artery MRI has excellent sensitivity and specificity for diagnosis.\n\nHowever, the high diagnostic performance of MRI has been achieved by performing 3D T1 black blood and fat saturation sequences in high resolution (\\\u003C0.7mm), which are not accessible in all centers in France and worldwide.\n\nThe realization of identical sequences with a lower resolution could allow a greater generalization of these sequences and improve the diagnostic management of GCA patients, including in non-expert centers.\n\nThe objective of our study is to investigate the diagnostic performance of several 3D T1 black blood and fat saturation sequences for the diagnosis of GCA.",[27],"2025-12-30",{"date":335,"type":39},"2026-01-05",{"date":337,"type":39},"2024-01-10",{"date":339,"type":21},"2027-06",{"name":341,"class":342},"Fondation Ophtalmologique Adolphe de Rothschild","NETWORK",{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":352,"conditions":353,"keywords":355,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":47},"100599437","giant-cell-arteritis---ways-to-precision-medicine-100599437","NCT07084480","Giant Cell Arteritis - Ways to Precision Medicine","Riesenzellarteriitis - Wege Zur \"Precision Medicine\"","Inclusion Criteria:\n\n* Age greater or similar to 18 years\n* Primary diagnosis of GCA or PMR\n\nExclusion Criteria:\n\n* Age under 18 years\n* lack of capacity to consent",{"count":351,"type":21},400,"Long-term follow-up of aortal adverse events, as well as glucocortioid-associated adverse events in patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA).",[27,354],"Polymyalgia Rheumatic (PMR)",[356,357,358,359,360],"non-interventional cohort study","aortic dilatation","innate lymhoid cells","optic coherence tomography","MRI","2025-12-15",{"date":363,"type":39},"2025-12-22",{"date":365,"type":39},"2025-11-14",{"date":367,"type":21},"2033-07-31",{"name":369,"class":46},"Wuerzburg University Hospital",{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":54,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":379,"conditions":380,"keywords":381,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":395},"100505720","vascular-mri-evaluation-in-giant-cell-arteritis-vega-100505720","NCT05865054","Vascular MRI Evaluation in Giant Cell Arteritis (VEGA)","A Longitudinal Study of Orbital and Cranial Vessel Wall MRI in Giant Cell Arteritis by the Vascular MRI Evaluation in Giant Cell Arteritis (VEGA) Collaborative","VEGA","Inclusion Criteria:\n\n* Age 50 years or older\n* First presentation of suspected GCA\n* New or worsening cranial manifestations within 4 weeks of enrollment concerning for active GCA\n* Elevated CRP greater than 1.0 mg\u002Fdl\n* Plan to undergo temporal artery biopsy or ultrasound for diagnosis\n\nExclusion Criteria:\n\n* Contra-indication to receiving MRI including:\n\nImplanted medical devices, pacemaker, and metallic foreign fragments inside body\u002Forbits Known gadolinium allergy Women who are pregnant or nursing\n\n* Absence of cranial symptoms related to GCA (e.g., only large vessel GCA)",{"count":351,"type":21},"The research study is being conducted to determine the utility of magnetic resonance imaging (MRI) in identifying inflammation of arteries supplying blood to the head, brain, and eyes. The target population includes patient with suspected giant cell arteritis (GCA; temporal arteritis).",[27],[118,382,383,384,385,386],"Horton's Giant Cell Arteritis","Horton's Disease","Horton Giant Cell Arteritis","Horton Disease","Cranial Arteritis","2025-09-15",{"date":389,"type":39},"2025-09-19",{"date":391,"type":39},"2020-07-29",{"date":393,"type":21},"2033-07",{"name":262,"class":46},4,{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":404,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":418},"100496811","optic-nerve-sheath-ultrasound-in-giant-cell-arteritis-100496811","NCT05749094","Optic Nerve Sheath Ultrasound in Giant Cell Arteritis","The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis","SONIC-GCA","Our population of interest is patients referred from any settings for suspected, new-onset GCA.\n\nInclusion criteria:\n\nTo be included in SONIC-GCA, participants must meet all the following criteria:\n\n1. Age \\> 50 years.\n2. Referral to a GCA clinic for suspected, new-onset GCA.\n3. Ability to understand and willingness to sign an informed consent form.\n4. Willingness to comply with study visits and procedures.\n\nExclusion criteria:\n\nAn individual who meets any of these criteria will be excluded from SONIC-GCA:\n\n1. Referral for a suspected GCA relapse.\n2. Current use of systemic glucocorticoids, with the following duration at the baseline visit: ≥ 14 consecutive days of oral glucocorticoids in the previous 30 days, or ≥ 7 consecutive days of oral glucocorticoids if intravenous glucocorticoids were administered in the previous 30 days.\n3. Current use of any conventional or biologic immunosuppressive therapy.\n4. Known previous medical history of retinal diseases, optic nerve diseases, demyelinating diseases, normotensive hydrocephalus, intracranial tumors (benign or malignant), or any conditions associated with intracranial hypertension.\n5. Any condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.",{"count":405,"type":21},285,"The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis (SONIC-GCA) study will evaluate the performance of the optic nerve sheath diameter (ONSD), measured via ultrasound, to diagnose and monitor GCA. SONIC-GCA builds upon our previous pilot studies and will answer the following questions:\n\n1. What is the performance of ONSD to identify patients with new-onset, active GCA?\n2. Is ONSD useful for monitoring GCA relapses during follow-up?\n3. What is the intra- and interobserver reliability of ONSD measurements?\n4. Does ONSD differ between patients with and without GCA-related retinal findings?",[27,408,409],"Anterior Ischemic Optic Neuropathy","Optic Neuropathy, Ischemic","2025-08-02",{"date":412,"type":39},"2025-08-07",{"date":414,"type":21},"2025-08",{"date":416,"type":21},"2029-03",{"name":129,"class":46},6,{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":54,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":428,"conditions":429,"keywords":430,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":47},"100551442","assessing-biomarker-in-giant-cell-arteritis-and-polymyalgia-rheumatic-100551442","NCT06460142","Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic","Multimodal Assessment of Biomarkers for Diagnosing Giant Cell Arteritis and Polymyalgia Rheumatica: A Comprehensive Analysis of Clinical, Laboratory, and Imaging Profiles","GCAIO","Inclusion Criteria:\n\n* Informed Consent: Participants (\\>18 years) must provide written informed consent to voluntarily participate in the study.\n* Confirmed Diagnosis: Diagnosis of GCA or PMR confirmed by the treating physician and fulfilling expanded ACR-EULAR classification criteria. Patients must have been either newly diagnosed within the last three days or have experienced a disease flare within the same timeframe.\n\nExclusion Criteria:\n\n* Severe Renal Insufficiency: Chronic glomerular filtration rate (GFR) less than 30 mL\u002Fmin.\n* Other Medical Conditions Requiring Glucocorticoids: Presence of medical conditions other than GCA or PMR that necessitate continuous or intermittent treatment with oral or parenteral glucocorticoids.\n* Other Inflammatory Rheumatic Diseases: Patients with other inflammatory rheumatic diseases.",{"count":139,"type":21},"The GCAIO study is an innovative, multimodal research initiative designed to enhance the understanding, diagnosis, and management of giant cell arteritis (GCA) and frequently associated polymyalgia rheumatica (PMR). This longitudinal study aims to dissect the complex immunological landscape and systemic manifestations of these conditions through a combination of diagnostic imaging and detailed immunological profiling.\n\nThe study focuses on three primary objectives: (1) Identifying and analyzing cytokine profiles and immune cell phenotypes, employing techniques like flow cytometry, enzyme-linked immunosorbent assays (ELISA), and next-generation sequencing to predict disease activity and therapeutic responses. (2) Advancing diagnostic and monitoring capabilities through the application of novel and established imaging technologies, including MRI, optical coherence tomography angiography (OCTA), and ultrasound. These modalities aim to improve the detection of neuro-ophthalmological, cardiac, and aortic complications in GCA, potentially offering more precise monitoring and earlier diagnosis. (3) Enhancing the understanding of PMR within the context of GCA by exploring specific biomarkers and advanced imaging to refine diagnostic accuracy and treatment strategies, thus improving patient outcomes.",[27,173],[27,173,241,431,432,433,434,435,436,437,438,439,440,441,442,443,444],"Inflammatory Disorders","Clinical Biomarkers","Predictive Biomarkers","Disease Activity Monitoring","Therapeutic Response","Diagnostic Imaging Techniques","Aortic Imaging","Magnetic Resonance Imaging (MRI)","Vascular Ultrasound","Optical Coherence Tomography Angiography (OCT-A)","Transcriptome Analysis","Vascular-adhesion protein 1","Positron emission tomography-computed tomography (PET\u002FCT)","Siglec-9","2025-04-07",{"date":447,"type":39},"2025-04-10",{"date":449,"type":39},"2023-09-01",{"date":451,"type":21},"2027-09-30",{"name":453,"class":46},"University of Bonn",{"id":455,"slug":456,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":464,"conditions":465,"keywords":470,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":418},"100508736","armenian-nationwide-registry-of-systemic-autoimmune-and-autoinflammatory-diseases-100508736","NCT05904301","Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases","Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases","NAREG","Inclusion Criteria:\n\n1. Patients with a confirmed diagnosis of at least one of following autoimmune systemic diseases:\n\n   Behcet disease, ANCA -positive vasculitis, Takayasu arteritis, Giant cell arteritis, Systemic sclerosis, Sjogren syndrome, Rheumatoid arthritis, Spondylarthritis (psoriatic, ankylosing, crohn's related), Angioedema hereditary and acquired, Pediatric dermatology, Autoinflammatory diseases (hereditary and acquired), Unexplained infertility, Immune thrombocytopenic purpura\u002F Autoimmune hemolytic anemia (ITP, AHA), Primary anti-phospholipid syndrome (APS), Celiac disease.\n2. Age: major and minor\n3. Patients who have been informed and provided with written informed consent to participate Or consent from legal representative\n\nExclusion Criteria:\n\n1. Patients refusing to participate in the registry\n2. Non-consent from legal representative\n3. Breastfeeding or pregnant patients",{"count":463,"type":21},800,"Longitudinal prospective multicenter Armenian registry of systemic autoimmune, autoinflammatory diseases with constitution of bio-banking.",[208,466,282,27,217,213,467,468,469],"Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis","Hereditary and Acquired Angioedema","Primary Antiphospholipid Syndrome","Celiac Disease",[471,472,473,474,475,476,477,478,479],"arthritis","autoimmune","systemic","autoinflammatory","Behcet","Takayasu","Giant Cell","Angioedema","APS","2025-04-04",{"date":482,"type":39},"2025-04-08",{"date":484,"type":39},"2023-06-21",{"date":486,"type":21},"2028-06-30",{"name":488,"class":46},"Santé Arménie French-Armenian Research Center",{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":496,"targetDuration":498,"studyType":58,"phases":4,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":510},"100370406","clinical-and-immunogenetic-characterization-of-giant-cell-arteritis-gca-and-polymyalgia-rheumatica-pmr-100370406","NCT04102930","Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)","UK GCA Consortium: Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)","Inclusion Criteria:\n\n* Willing to self-identify an ethnic group, such as Caucasian, Asian, Afro-Caribbean.\n* Have a firm clinical diagnosis of GCA or PMR, or (for patients identified prospectively) GCA or PMR should be more likely than any alternative explanation for the patient's symptoms.\n* Able and willing to give informed consent. Patients will be 50 years of age or over, unless both biopsy-proven and a clinically classical case of GCA.\n\nExclusion Criteria:\n\n• Patient unwilling or unable to give fully informed consent.",{"count":497,"type":21},4500,"18 Months","A multi-centre observational study recruiting prospective and retrospective cohorts of patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA). The primary aim is to find genetic determinants of GCA and PMR susceptibility, in order to yield novel insights into disease pathogenesis. A subset of the retrospective cohort is also enrolled in a post-marketing surveillance registry of patients eligible for, or receiving tocilizumab, to treat their relapsing or refractory GCA.",[27,173],"2025-03-25",{"date":503,"type":39},"2025-03-30",{"date":505,"type":39},"2005-06-10",{"date":507,"type":21},"2028-03-31",{"name":509,"class":46},"University of Leeds",76,{"id":512,"slug":513,"hasResults":11,"nctId":514,"briefTitle":515,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":11,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":520,"conditions":521,"keywords":529,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":47},"100554564","visual-involvement-in-giant-cell-arteritis-100554564","NCT06500728","Visual Involvement in Giant Cell Arteritis","Visu-GCA","Inclusion Criteria:\n\n* For GCA group:\n\n  * Patients older than 18 years with clinically suspected or confirmed gigantocellular arteritis.\n  * Newly found visual involvement with suspected or confirmed correlation with vasculitis.\n  * Ability to express valid consent to study enrolment.\n* For control group:\n\n  * Patients older than 18 years with the ability to express valid consent to study enrolment.\n  * Newly diagnosed acute visual impairment with GCA phenotypes (e.g. AION, CRAO) but without any correlation with vasculitis aetiology.\n\nExclusion Criteria:\n\n* Pre-existing ophthalmological pathologies that may modify best visual acuity and\u002For alter ophthalmological semeiotics.\n* Concomitant active viral, bacterial, fungal and parasitic infections, including active or latent tuberculosis treated for less than 4 weeks and HIV, hepatitis C virus (HCV)\n\n  \u002Fhepatitis B virus (HBV) infections, involving the eyes and orbital cavities.\n* Concomitant systemic inflammations not attributable to GCA (inflammatory diseases in treatment-free remission are not excluded).\n* Any other condition judged by the investigators to be a contraindication of eligibility",{"count":519,"type":21},762,"This observational study aims to enhance the description of the different ways Giant Cell Arteritis (GCA) affects vision. The latest technology and knowledge are used to improve how we diagnose and predict patient outcomes. GCA is the most frequent vasculitis, an inflammation of vessels, in older adults. It involves large and medium-sized arteries and causes ischemic alterations such as stroke and blindness, through damage of extracranial arteries.\n\nThe primary objective is to compare the frequency of the various ocular findings between the main alterations of arteritic and non-arteritic aetiology, such as Arteritic Anterior Ischemic Optic Neuropathy (A-AION) Vs. Non-Arteritic Anterior Ischemic Optic Neuropathy (NA-AION) or Central Retinal Artery Occlusion (CRAO) from GCA Vs. from other causes, through a comprehensive clinical and instrumental evaluation.",[27,522,523,408,524,525,526,527,528],"Visual Impairment","Central Retinal Artery Occlusion","Paracentral Acute Middle Maculopathy","Posterior Ischemic Optic Neuropathy","Retinal Ischemia","Blindness","Visual Disorder",[27,530,531,532,533,534,535],"Visual impairment","Optical Coherence Tomography (OCT)","High resolution Optical Coherence Tomography (HR-OCT)","Angio-Optical Coherence Tomography (OCT-A)","Fluorescein angiography","Indocyanine green angiography","2024-07-08",{"date":538,"type":39},"2024-07-15",{"date":540,"type":39},"2024-06-27",{"date":542,"type":21},"2030-06",{"name":544,"class":46},"ASST Fatebenefratelli Sacco",{"id":546,"slug":547,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":47},"100516410","post-therapeutic-imaging-evaluation-of-patients-with-hortons-disease-giant-cell-arteritis-evhortim-100516410","NCT06004154","Post-therapeutic Imaging Evaluation of Patients With Horton's Disease (Giant Cell Arteritis) (EvHortim)","Post-therapeutic Imaging Evaluation of Patients With Horton's Disease (Giant Cell Arteritis)","EvHortim","Inclusion Criteria:\n\n* Patient aged 50 and over\n* Having received informed consent to participate in the study\n* Affiliated or beneficiary of a social insurance scheme\n* Patients with giant cell arteritis according to ACR\u002FEULAR 2022 criteria\n* Diagnosed with MRI and ultrasound.\n\nExclusion Criteria:\n\n* Absolute or relative contraindication to MRI (incompatible implantable device, claustrophobia, etc.)\n* Hypersensitivity to gadobutrol\n* Patient under legal protection\n* Pregnant or breast-feeding women",{"count":554,"type":21},50,"Giant cell arteritis (GCA), also known as Horton's disease, is an inflammatory arteritis of the large and medium-sized arteries, with an estimated incidence of 17.8\u002F100,000 in people over 50.\n\nThe disease presents potential ophthalmological, neurological, cardiac and aortic vascular complications, making diagnosis an emergency in cases of suspected Horton's disease.\n\nonly corticosteroid therapy started as early as possible can prevent these complications.\n\nDiagnosis has historically relied on temporal artery biopsy, but the recent ACR\u002FEULAR 2022 classification criteria propose alternatives to this invasive examination, in particular imaging tests such as temporal artery ultrasound and PET scans. Although not included in these latest recommendations, high-definition wall MRI can also provide arguments in favor of this diagnosis, and avoid the need for a temporal artery biopsy, the sensitivity of which is only 75%. The investigators recently demonstrated in a prospective cohort that wall MRI, possibly coupled with temporal artery ultrasound or retinal angiography, was far superior to temporal artery biopsy in diagnostic performance.\n\nThe main limitation of these imaging tests is the lack of data in the literature on the evolution of abnormalities over time, and in particular after initiation of oral corticosteroid therapy. This uncertainty makes it difficult to use these examinations to monitor disease activity, particularly in cases of suspected relapse, a frequent situation in which the clinician is regularly put at fault due to an often frustrating symptomatology and the possible absence of a frank biological inflammatory syndrome.\n\nThe investigators propose to conduct a study aimed at describing the evolution of cranial vessel wall abnormalities on wall MRI and ultrasound by systematically repeating these examinations at 1 month, 3 months from the initial MRI performed at diagnosis, in addition to the follow-up performed as part of care at 6 and 12 months from diagnosis. In the event of a relapse in the intervening period, a new MRI scan can be performed and compared with the most recent MRI scan, to look for evidence of disease activity.",[27],"2024-06-03",{"date":559,"type":39},"2024-06-04",{"date":561,"type":39},"2023-11-28",{"date":563,"type":21},"2027-04",{"name":341,"class":342},{"id":566,"slug":567,"hasResults":11,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":54,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":574,"conditions":575,"keywords":576,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":157},"100537533","investigation-of-the-influence-of-the-human-microbiome-on-giant-cell-arteritis-100537533","NCT06279065","Investigation of the Influence of the Human Microbiome on Giant Cell Arteritis","Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis","GCA-Biom","Inclusion Criteria:\n\n• Diagnosis of Giant cell arteritis (only in one arm)\n\nExclusion Criteria:\n\n* chronic infection (viral, fungi, bacteria) including human immunodeficiency viruses, Hepatitis B\u002FC\n* acute infection with usage of antibiotics less then 90 days before screening\n* major gastro-intestinal surgery \\\u003C5 years from screening\n* gastro-intestinal bleeding \\\u003C90 days before screening\n* inflammatory bowel disease (confirmed bioptically)\n* bulimia or anorexia nervosa\n* adipositas (body mass index ≥ 40)\n* intake of high dosage of probiotics (\\>10\\^9 colony forming units per day) \\\u003C90 days before screening\n* not controlled Diabetes mellitus\n* Malignancy within one year (except for squamous skin - and basal skin carcinoma without metastasis, cervix carcinoma with curative surgery, Cutaneous T-cell lymphoma)\n* known abuse of alcohol oder drugs.",{"count":554,"type":21},"The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (abbr. GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate biota will be further analyzed for possible interactions and influence on the immune system.",[27],[577],"microbiome","2024-05-07",{"date":580,"type":39},"2024-05-09",{"date":582,"type":39},"2024-02-29",{"date":584,"type":21},"2028-02",{"name":453,"class":46},{"id":587,"slug":588,"hasResults":11,"nctId":589,"briefTitle":590,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":54,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":595,"conditions":596,"keywords":599,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":4},"100534841","clonal-hematopoiesis-in-giant-cell-arteritis-100534841","NCT06244069","Clonal Hematopoiesis in Giant Cell Arteritis","CH-GCA","Inclusion Criteria:\n\n* Patients with suspected active GCA entering into a fast-track work-up and healthy matched controls.\n* Capability of providing valid consent to study enrollment.\n* Possibility of performing temporal artery biopsy within three hours from enrollment.\n\nExclusion Criteria:\n\n* Active concurrent viral, fungal or bacterial infections (including active\u002Flatent tuberculosis treated for less than 4 weeks, HIV and Hepatitis B\u002FC virus (HBV\u002FHCV) infections.\n* Concurrent systemic inflammation not attributable to GCA (inflammatory diseases in treatment-free remission are accepted).\n* Use of other immunosuppressive agents in the last 3 months.\n* Use of systemic steroids (any dose in the last week, \\> 15 mg\u002Fdie of prednisone equivalent in the last month).\n* Solid or hematologic malignancies (active or with less than 6 months free of disease or antiblastic chemotherapy (hormone therapy is allowed).\n* Previous solid or hematopoietic stem cell transplantation (corneal transplants are allowed).\n* Any systemic immunosuppressive or steroidal therapy.\n* Chronic renal failure with Glomerular Filtration Rate (GFR) \\\u003C 45 ml\u002Fmin \\*1.73 m2.\n* Moderate-severe liver failure (Child-Pugh B or C), hepatitis in stages of activity.\n* Diabetes mellitus.\n* Heart failure with New York Heart Association score (NYHA) \\>=2.\n* Severe hypoproteinemia\u002Fmalnutrition.\n* Chronic respiratory failure requiring O2 therapy or ventilation therapy at home.\n* Any other condition judged by the local investigator as a contra-indication to eligibility.",{"count":594,"type":21},326,"The goal of this clinical trial is to verify whether CHIP is correlated with the clinical, instrumental, and histological characteristics of GCA, and to characterize the pathogenetic effects of clonal hemopoiesis on vasculitis. The main objective of this study is to verify if clonal hematopoiesis of indeterminate potential (CHIP) affects GCA manifestations, course\u002Fresponse to therapies, and pathogenesis.\n\nPatients who are going to be diagnosed with GCA and for which a fast track is available for a rapid diagnostic work-up including pre-treatment temporal artery biopsy. Patients with CHIP will be identified and characterized by using whole exome sequencing from the peripheral blood samples. The presence and characteristics of CHIP will be correlated with baseline clinical, instrumental, and histologic GCA features.",[27,118,597,385,598],"Clonal Hematopoiesis of Indeterminate Potential","Systemic Vasculitis Primary",[600,601,597,602,603,29,604],"Temporal artery biopsy","Giant cell arteritis","Single cell transcriptomics","Large vessels vasculitis","Whole Exome Sequencing","2024-02-02",{"date":607,"type":39},"2024-02-06",{"date":609,"type":21},"2024-03",{"date":611,"type":21},"2031-03",{"name":544,"class":46},{"id":614,"slug":615,"hasResults":11,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":621,"targetDuration":198,"studyType":58,"phases":4,"briefSummary":623,"conditions":624,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":157},"100511151","danish-vasculitis-database-danivas-100511151","NCT05935709","DANIsh VASculitis Database (DANIVAS)","Disease Stratification in GCA and PMR to Inform Management and Reduce Disease and Treatment-related Damage","DANIVAS","Inclusion Criteria:\n\n* Are diagnosed with GCA or PMR within the last 5 years\n* Diagnosis is established by or confirmed by a rheumatologist (clinical expert opinion)\n* Speak and understand Danish\n* Are able to give signed and dated informed consent\n\nExclusion Criteria:\n\n* Denies or are not able to give informed consent\n* Are diagnosed with other systemic autoimmune diseases that out-rules the diagnosis of GCA or PMR",{"count":622,"type":21},3000,"The aim of this national pragmatic observational study is to investigate whether the use of new diagnostic imaging modalities facilitates disease stratification that can potentially predict treatment response, relapse risk and complications and hence guide management strategies to improve disease control and reduce disease and treatment related damage.",[27,173],"2024-01-22",{"date":627,"type":39},"2024-01-24",{"date":629,"type":39},"2023-11-10",{"date":631,"type":21},"2051-12-31",{"name":633,"class":46},"Aarhus University Hospital"]