[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"polyangiitis-gpa\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:polyangiitis-gpa":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"ANCA Associated Vasculitis (AAV)","Polyangiitis (GPA)","Microscopic Polyangiitis (MPA)",[31,32,33,34],"ANCA","Granulomatosis with polyangiitis","Microscopic polyangiitis","Rituximab","NOT_YET_RECRUITING","2026-03-02",{"date":38,"type":39},"2026-03-05","ACTUAL",{"date":41,"type":21},"2026-02",{"date":43,"type":21},"2030-02",{"name":45,"class":46},"Assistance Publique - Hôpitaux de Paris","OTHER"]