Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-05 @ 5:50 PM
Study NCT ID:
NCT01727232
Status:
COMPLETED
Last Update Posted:
2012-11-15
First Post:
2012-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-12', 'studyFirstSubmitDate': '2012-11-12', 'studyFirstSubmitQcDate': '2012-11-12', 'lastUpdatePostDateStruct': {'date': '2012-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion.', 'timeFrame': 'one year', 'description': 'A complete response (CR) was defined as a platelet count \\>100 x 109/l and a response (R): by a platelet count \\>30 x 109/l with a least a doubling of the baseline value without any rescue intervention within 8 weeks before assessment, and no response (NR) was defined as a platelet count lower than 30 x 109/'}], 'secondaryOutcomes': [{'measure': 'The response rate 3months, and at the last follow-up after the first rituximab infusion. Variable associated with RTX response.', 'timeFrame': '3 months, one year, last follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ITP', 'Rituximab', 'Efficacy', 'Anti-CD20', 'Regimen'], 'conditions': ['Primary Immune Thrombocytopenia']}, 'descriptionModule': {'briefSummary': "The aim of this large French multicentric retrospective study was to compare the efficacy and safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's immune thrombocytopenia .", 'detailedDescription': 'Every adult (age ≥ 18 years) seen in one of the 3 participating centre (dijon, Marseille, Mondor) over a 7-year period (2005-2012) with a definite diagnosis of primary ITP according to the American Society Hematology guidelines who received RTX regardless the regimen could be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary ITP patients treated with standard or RA regimen were retrospectively included in the observationnal study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary ITP\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Secondary ITP\n* Age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT01727232', 'briefTitle': "Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia", 'organization': {'class': 'OTHER', 'fullName': 'Henri Mondor University Hospital'}, 'officialTitle': "Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia", 'orgStudyIdInfo': {'id': 'Mondor-Rituxcompare'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard regimen', 'description': 'Patients received the standard regimen (i.e 4 weekly infusions of 375 mg/m2)of rituximab'}, {'label': 'Rheumatoid arthritis regimen', 'description': 'Patients received the RA regimen (i.e two infusions of 1000 mg, 2 weeks apart) of rituximab'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henri Mondor University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dr Mahévas Matthieu, MD', 'investigatorAffiliation': 'Henri Mondor University Hospital'}}}}