[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643234":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":53,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":76,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NALVANCA Cohort - ANCA-associated vasculitis patients treated with Rituximab.",null,"This cohort follows adult patients with ANCA-associated vasculitis, a systemic autoimmune disease. The intervention of interest is Rituximab (RTX) therapy, used to induce B-cell depletion. The study involves longitudinal monitoring with the systematic collection of biological samples at key time points: before treatment induction, during the depletion phase, and upon immune reconstitution (2 years after the last injection or at relapse). The objective is to study the pleiotropic effects of B-cell depletion on CD8+ T-cells to identify biomarkers capable of predicting the risk of relapse.",[13,14],"Other: systematic collection of additional biological samples (blood volume)","Diagnostic Test: BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index)",[16,19],{"type":6,"name":17,"description":17,"armGroupLabels":18,"otherNames":10},"systematic collection of additional biological samples (blood volume)",[9],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DIAGNOSTIC_TEST","BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index)","BVAS (Birmingham Vasculitis Activity Score) and VDI (Vasculitis Damage Index) are standardized clinical assessment tools used in vasculitis studies. BVAS is a physician-reported score that evaluates current disease activity across organ systems, capturing the presence and severity of active vasculitic manifestations. In contrast, VDI measures accumulated and irreversible organ damage resulting from vasculitis and\u002For its treatment over time, irrespective of current disease activity. Together, these instruments allow comprehensive evaluation of both disease activity and long-term patient outcomes in clinical trials.",[9],[25],{"name":26,"affiliation":27,"role":28},"Nicolas Degauque, PhD","CR2TI - UMR1064 (INSERM)","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Antoine Néel, Pr","CONTACT","+33.2.40.08.33.55","antoine.neel@chu-nantes.fr",[36],{"facility":37,"status":10,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"CHU de Nantes","Nantes","Loire-atlantique","44093","France","FR",{"type":44,"coordinates":45},"Point",[46,47],-1.55336,47.21725,{"lat":47,"lon":46},[50],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[54],{"name":27,"class":55},"UNKNOWN","100643234","immune-monitoring-following-b-cell-depletion-in-anca-associated-vasculitis-100643234",false,"NCT07636655","Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis","NALVANCA: Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis","NALVANCA","Inclusion criteria :\n\n* Adult patient (age ≥ 18 years).\n* Patient affiliated with the French social security system.\n* Seropositive ANCA-associated vasculitis (AAV) (positive for anti-PR3 or anti-MPO) meeting the Chapel-Hill classification criteria.\n* Patient scheduled to receive rituximab (RTX) maintenance therapy (500 mg every 6 months) following an initial flare or a relapse of the disease.\n\nExclusion Criteria:\n\n* Patient unable to provide informed consent.\n* Patient refusing to participate in the study.\n* End-stage renal disease.\n* Progressive neoplasia (excluding cutaneous carcinomas)","ALL","18 Years",{"count":67,"type":68},120,"ESTIMATED","OBSERVATIONAL","ANCA-associated vasculitis is a serious autoimmune disease. The standard treatment is rituximab (RTX), which depletes B-cells to control inflammation. However, identifying patients at high risk of relapse remains a challenge, often leading to unnecessarily long treatments and side effects. Recent research suggests that RTX also impacts CD8+ T-cells, which could serve as valuable markers for better disease monitoring.\n\nThe main goal of the NALVANCA cohort is to identify biomarkers within these CD8+ T-cells. Researchers aim to find biological signals that respond to treatment and can predict a relapse. By studying these markers at the start of therapy and during the immune recovery phase, the study hopes to personalize treatment duration and management for each patient.\n\nRecruitment targets adult patients diagnosed with ANCA-associated vasculitis. Participants must provide written informed consent for the use and storage of their blood samples in a biocollection. The protocol involves long-term monitoring with regular sampling to track changes in immune cells alongside the patient's clinical health.",[72],"Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies",[74,75],"ANCA","AAV","NOT_YET_RECRUITING","2026-07-03",{"date":79,"type":80},"2026-07-07","ACTUAL",{"date":82,"type":68},"2026-09-01",{"date":84,"type":68},"2051-09-01",{"name":5,"class":6},1]