[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627685":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":43,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":18,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":92,"whyStopped":18,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rituximab","EXPERIMENTAL","Rituximab 500 mg administered intravenously (IV) every 6 months for a total duration of 18 months, depending on ANCA positivity.",[13],"Drug: Rituximab",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Standard care follow up",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","500 mg IV every 6 months for a total duration of 18 months depending on ANCA positivity.",[9],[25,26,27],"Mabthera","Tuxima","Rixathon",[29],{"name":30,"affiliation":5,"role":31},"Benjamin TERRIER, PhD","STUDY_CHAIR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Florence DELESTRE, MD","CONTACT","01 58 41 41 17","+33","florence.delestre@aphp.fr",{"name":40,"role":35,"phone":41,"phoneExt":37,"email":42},"Adèle BELLINO","01 58 41 11 95","adele.bellino@aphp.fr",[44],{"facility":45,"status":18,"city":46,"state":18,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hôpital Cochin","Paris","75014","France","FR",{"type":51,"coordinates":52},"Point",[53,54],2.3488,48.85341,{"lat":54,"lon":53},[57,59],{"name":34,"role":35,"phone":58,"phoneExt":37,"email":38},"01 58 41 41 27",{"name":30,"role":35,"phone":60,"phoneExt":37,"email":61},"01 58 41 14 61","benjamin.terrier@aphp.fr",{"type":63,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[65],{"name":66,"class":6},"URC-CIC Paris Descartes Necker Cochin","100627685","phase-4-comparison-of-a-strategy-based-on-clinico-biological-monitoring-versus-pre-emptive-rituximab-treatment-in-cases-of-anca-reappearance-in-granulomatosis-with-polyangiitis-and-microscopic-polyangiitis-100627685",false,"NCT07451847","Comparison of a Strategy Based on Clinico-biological Monitoring Versus Pre-emptive Rituximab Treatment in Cases of ANCA Reappearance in Granulomatosis With Polyangiitis and Microscopic Polyangiitis.","Comparison of Clinico-biological Monitoring Versus Pre-emptive Rituximab Treatment for ANCA Repositivation in Granulomatosis With Polyangiitis and Microscopic Polyangiitis: a Prospective, Multicenter, Randomized Controlled Study.","PREP-ANCA","Inclusion Criteria:\n\n* Adult patients aged ≥ 18 years\n* Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the 2022 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria\n* Maintenance treatment with rituximab for at least 18 months, administered as follows: a 500 mg infusion on day 1 (with an optional repeat dose on day 15), followed by 500 mg infusions every 6 months for a total of 4 to 5 doses\n* Patient in complete remission, defined as a Birmingham Vasculitis Activity Score (BVAS) of 0 at the time of randomization\n* ANCA repositivity (confirmed by antigen-specific testing) within the 3 months prior to randomization\n* Ability to provide written informed consent prior to participation\n* Affiliation to a national health insurance or social security scheme\n\nExclusion Criteria:\n\n* Diagnosis of any vasculitis other than GPA or MPA\n* Active disease relapse, defined as BVAS \\> 0\n* Acute active infection requiring hospitalization or intravenous anti-infective therapy within 4 weeks prior to screening, or oral anti-infective treatment within 2 weeks prior to screening\n* History of deep tissue infections (e.g., fasciitis, abscess, osteomyelitis, septic arthritis) within 12 months prior to inclusion\n* History of severe, chronic, or recurrent infections, or any underlying condition predisposing the patient to serious infections\n* Administration of a live vaccine within 4 weeks prior to study inclusion\n* Active malignancy or history of hematologic malignancy within the past 5 years, except for localized prostate cancer or basal cell carcinoma of the skin\n* Presence of systemic diseases for which the study treatments may have unpredictable or inappropriate consequences\n* History of severe allergic or anaphylactic reactions, or known hypersensitivity to humanized or murine monoclonal antibodies and\u002For corticosteroids\n* Known hypersensitivity to any monoclonal antibody or biologic agent\n* Patients previously deemed non-responders or failures to rituximab therapy\n* Suspicion of poor adherence to treatment or anticipated inability or refusal to comply with the required follow-up visits and procedures\n* Inability or refusal to provide written informed consent Pregnant or breastfeeding women. Women of childbearing potential must use effective contraception during the study and for 6 months after the last infusion. Breastfeeding is contraindicated during treatment and for 6 months following the final rituximab dose.","ALL","18 Years",{"count":78,"type":79},70,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","The PREP-ANCA study seeks to establish a more personalized treatment strategy for ANCA-associated vasculitides by assessing the efficacy of pre-emptive rituximab administration upon ANCA repositivity in preventing relapses in granulomatosis with polyangiitis and microscopic polyangiitis.",[85,86,87],"ANCA Associated Vasculitis (AAV)","Polyangiitis (GPA)","Microscopic Polyangiitis (MPA)",[89,90,91,9],"ANCA","Granulomatosis with polyangiitis","Microscopic polyangiitis","NOT_YET_RECRUITING","2026-03-02",{"date":95,"type":96},"2026-03-05","ACTUAL",{"date":98,"type":79},"2026-02",{"date":100,"type":79},"2030-02",{"name":5,"class":6},1]