Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 9:22 AM
Study NCT ID:
NCT07037732
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D056647', 'term': 'Systemic Vasculitis'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2025-05-23', 'studyFirstSubmitQcDate': '2025-06-23', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients with (Immune Thrombocytopenia) ITP', 'timeFrame': 'At each consultation during 5 years', 'description': 'Hematologic relapse described as a drop in platelet count below 20 G/L following a remission phase of at least 3 months with platelet count greater than 50 G/L.'}, {'measure': 'Patients with AIHA Autoimmune Hemolytic Anemia.', 'timeFrame': 'At each consultation during 5 years', 'description': 'Hematologic relapse described as a drop in hemoglobin level below 10 g/dL (with a lost of at least 2 g/dL from baseline) in association with hemolysis after e remission of at least 3 months'}, {'measure': 'Patients with inflammatory myopathy', 'timeFrame': 'At each consultation during 5 years', 'description': 'Clinical relase defined as a confirmed muscular (myalgia associated with at least one from the following : increase CK levels, new or worsening electromyography, new or worsening muscle inflammation on MRI), joint or pulmonary new symptoms related to myositis'}, {'measure': 'Patients with systemic lupus erythematous :', 'timeFrame': 'At each consultation during 5 years', 'description': 'Clinical relapse defined as an increase by 4 points in the SLEDAI (systemic lupus erythematous disease activity index) score'}, {'measure': 'Patients with systemic vasculitis', 'timeFrame': 'At each consultation during 5 years', 'description': 'Clinical relapse defined as an increase by 1 points in the Birmingham vasculitis (BVAS) score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Autoimmune Cytopenia', 'Connective Tissue Disorder', 'Systemic Vasculitis']}, 'descriptionModule': {'briefSummary': "The MONIRITUX study aimed to evaluate whether monitoring (i) circulating B-cell reconstitution or (ii) serum rituximab levels could help identify relapse of autoimmune diseases in patients treated with rituximab. Retrospective data suggest that B-cell reconstitution or the appearance of anti-drug antibodies are associated with rituximab's failure to prevent relapses (i.e. rheumatoid arthritis, systemic lupus erythematosus, autoimmune cytopenia...). According to the routine care provided by our institution, patients undergoing rituximab therapy are monitored every three months during the first year after treatment induction and every six months thereafter. At each clinical visit, a blood test is performed to quantify total gammaglobulins, IgG and CD19+ cells (along with other tests depending on the disease). This study will use the remaining blood in the tubes from routine care to quantify CD27+ and CD38+ B cells, as well as serum rituximab and anti-rituximab antibodies, during the first year of follow-up. The primary outcome will be to identify risk factors for clinical relapse according to circulating B-cell or rituximab status."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who undergo rituximab treatment according to routine care and having one of the following disorder:\n\n* primary immune thrombocytopenia\n* primary autoimmune hemolytic anemia\n* systmic lupus erythematous\n* systemic sclerosis\n* rheumatoid arthritis\n* inflammatory myopathy\n* ANCA associated vasculitis\n* Cryoglobulinemic vasculitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who undergo rituximab treatment according to routine care and having one of the following disorder:\n* primary immune thrombocytopenia\n* primary autoimmune hemolytic anemia\n* systmic lupus erythematous\n* systemic sclerosis\n* rheumatoid arthritis\n* inflammatory myopathy\n* ANCA associated vasculitis\n* Cryoglobulinemic vasculitis\n\nExclusion Criteria:\n\n* Patients undergoing multiple immunosuppressive drugs because of refractory disease or concomitant hemopathy or malignancy'}, 'identificationModule': {'nctId': 'NCT07037732', 'briefTitle': 'Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders : the MONIRITUX Study', 'orgStudyIdInfo': {'id': '25Immuno01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Autoimmune cytopenia (immune thrombocytopenia or hemolytic anemia)', 'description': 'Blood CD19+, CD27+, and CD38+ B-cell reconstitution, circulanting rituximab level or the presence of circulating anti-rituximab antibodies will be compared in patients experiencing clinical relapse and those who will remain stable over time.'}, {'label': 'Connective tissu disorder (SLE, myopathie, RA…)', 'description': 'Blood CD19+, CD27+, and CD38+ B-cell reconstitution, circulanting rituximab level or the presence of circulating anti-rituximab antibodies will be compared in patients experiencing clinical relapse and those who will remain stable over time.'}, {'label': 'Systemic vasculitis (ANCA, essential cryoglobulinemia)', 'description': 'Blood CD19+, CD27+, and CD38+ B-cell reconstitution, circulanting rituximab level or the presence of circulating anti-rituximab antibodies will be compared in patients experiencing clinical relapse and those who will remain stable over time.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'state': 'Alpes Maritimes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'MICHAEL LEVRAUT', 'role': 'CONTACT', 'email': 'levraut.m@chu-nice.fr', 'phone': '04.92.03.54.44', 'phoneExt': '+ 33'}, {'name': ': levraut.m@chu-nice.fr Levraut', 'role': 'CONTACT', 'email': 'levraut.m@chu-nice.fr', 'phone': '04.92.03.54.44', 'phoneExt': '+33'}], 'facility': 'Chu de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'MICHAEL Levraut', 'role': 'CONTACT', 'email': 'levraut.m@chu-nice.fr', 'phone': '04.92.03.54.44', 'phoneExt': '+ 33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}