[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589637":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":44,"responsibleParty":64,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":25,"enrollmentInfo":79,"targetDuration":25,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":90,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bosentan + Glucocorticoids","EXPERIMENTAL","Bosentan : 62.5 mg bid for 4 weeks and 125 mg bid during 9 additional weeks Glucocorticoids : prespecified GC tapering schedule",[13],"Drug: Bosentan",{"label":15,"type":6,"description":16,"interventionNames":17},"Glucocorticoids","prespecified GC tapering schedule",[18],"Drug: Glucocorticoids",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Bosentan","Bosentan : 62.5 mg twice a day for 4 weeks and 125 mg twice a day during 9 weeks (treatment length 3 months)",[9],null,{"type":21,"name":15,"description":16,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":31,"role":32},"Luc MOUTHON, Pr","Hôpital Cochin, Department of Internal Medicine - 75014, Paris","STUDY_DIRECTOR",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Alexis REGENT, Pr","CONTACT","01 58 41 14 55","+33","alexis.regent@aphp.fr",{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},"Charly LARRIEU, Project advisor","01 58 41 34 78","charly.larrieu@aphp.fr",[45],{"facility":46,"status":25,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Unité de Recherche Clinique, Entrepôts de données et Pharmacologie GHU Paris Centre","Paris","75005","France","FR",{"type":52,"coordinates":53},"Point",[54,55],2.3488,48.85341,{"lat":55,"lon":54},[58,60],{"name":59,"role":36,"phone":37,"phoneExt":38,"email":39},"Alexis REGENT, MD\u002FPhD",{"name":61,"role":36,"phone":62,"phoneExt":38,"email":63},"Luc Mouthon, MD, PhD","01 58 41 20 31","luc.mouthon@aphp.fr",{"type":65,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[67],{"name":68,"class":6},"URC-CIC Paris Descartes Necker Cochin","100589637","phase-2-bosentan-in-the-treatment-of-giant-cell-arteritis-100589637",false,"NCT06957002","Bosentan in the Treatment of Giant Cell Arteritis","Bosentan in the Treatment of Giant Cell Arteritis. Multicenter, Randomized, Controlled, Superiority Phase II Trial Comparing a Combination of Bosentan and Glucocorticoids Versus Glucocorticoids Alone in the Treatment of Patients With GCA","BOSICART","* Inclusion Criteria :\n* Patients having given their written informed consent prior to participation in the study\n* Patients affiliated with social security or CMU (profit or being entitled)\n* Diagnosis of GCA, as defined by the revised GCA diagnosis criteria. Patients must satisfy criteria 1-2-3 and 4 (irrespective of time):\n\n  * Age ≥50 years at disease onset\n  * History of erythrocyte sedimentation rate (ESR) ≥ 50 mm\u002Fh or CRP ≥ 20 mg\u002FL (not mandatory if TAB is positive: see below)\n  * At least one of the following:\n* unequivocal cranial symptoms of GCA (new onset headache, scalp tenderness, jaw claudication, temporal artery abnormality, ischemia-related vision loss)\n* unequivocal symptoms of polymyalgia rheumatica (PMR)\n\n  * At least one of the following:\n* Temporal artery biopsy (TAB) compatible with the diagnosis of GCA (non-necrotizing vasculitis with a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells)\n* Evidence of large vessel vasculitis:\n\n  * angio-CT or angio-MRI: thickened and\u002For contrast-enhanced arteries especially aorta (≥2mm) and epiaortic arteries (≥1mm) and contrast enhanced arteries in T1-weighted sequences\n  * or PET scan: ≥ grade 2 (from 0 to 3) tracer uptake on large arteries\n* At least a sign of active GCA within the 2 weeks prior to randomisation. Active GCA is defined by ESR ≥30 mm\u002Fh or CRP ≥10 mg\u002FL and at least one of the following:\n* unequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise unexplained mouth or jaw pain upon mastication)\n* unequivocal symptoms of PMR, defined as shoulder and\u002For hip girdle pain associated with inflammatory stiffness\n* other features judged by the clinical investigator to be consistent with GCA or PMR flares\n* Menopausal women (no gynaecological cycle over the past two years), or women who had a gynaecological cycle within previous 24 months (non-menopausal women) only if they have (1) an effective non hormonal contraceptive method throughout study and (2) a negative urinary beta-hCG test at inclusion.\n\nExclusion Criteria:\n\n* Patients under maintenance of justice, wardship or legal guardianship\n* Patient unable to give written informed consent prior to participation in the study\n* Patients included in other investigational therapeutic study within the previous 3 months\n* Patients suspected not to be observant to the proposed treatments\n* Weight \\\u003C40 Kg or \\> 100 Kg\n* Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C. History of chronic alcohol abuse (consumption \\> 20 g\u002Fday)\n* Severe chronic heart failure or severe systolic dysfunction\n* Recent (\\\u003C 3 months) or incoming surgery requiring a general anaesthesia\n* History of stem cell or organ transplantation (except corneas if performed more than 3 months prior inclusion)\n* Hypersensitivity to bosentan or one of its excipients\n* Prior treatment with any of the following:\n\n  * Tocilizumab or methotrexate or secukinumab within 12 weeks preceding inclusion\n  * Cell-depleting agents (i.e., anti-CD20)\n  * Alkylating agents including cyclophosphamide\n  * Hydroxychloroquine, cyclosporine A, dapsone, azathioprine, mycophenolate mofetil or janus kinase inhibitors within 4 weeks preceding inclusion\n  * Tumor necrosis factor inhibitors within 8 weeks preceding inclusion\n  * Anakinra within 1 week preceding inclusion\n* Ongoing treatment with glibenclamide, fluconazole and rifampicin. Concomitant administration of both a CYP3A4 inhibitor or a CYP2C9 inhibitor\n* Long-course systemic glucocorticoid therapy for other conditions than GCA or PMR\n* Laboratory abnormalities: AST or ALT \\>3 x upper limit of normal (ULN)\n* Infections:\n\n  * Active hepatitis B or C\n  * HIV infection","ALL","50 Years",{"count":80,"type":81},40,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","The purpose of this study is to determine whether a treatment with 3 months of bosentan associated to standard therapy might be superior to glucocorticoids alone in term of failure free survival at 12 months",[87],"Giant Cell Arteritis (GCA)",[89,22],"Giant Cell Arteritis","NOT_YET_RECRUITING","2026-04-30",{"date":93,"type":94},"2026-05-06","ACTUAL",{"date":96,"type":81},"2026-06",{"date":98,"type":81},"2030-06",{"name":5,"class":6},1]