Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:37 PM
Study NCT ID:
NCT00307593
Status:
COMPLETED
Last Update Posted:
2007-11-19
First Post:
2006-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014890', 'term': 'Granulomatosis with Polyangiitis'}, {'id': 'D015267', 'term': 'Churg-Strauss Syndrome'}, {'id': 'D055953', 'term': 'Microscopic Polyangiitis'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}, {'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006099', 'term': 'Granuloma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-16', 'studyFirstSubmitDate': '2006-03-24', 'studyFirstSubmitQcDate': '2006-03-24', 'lastUpdatePostDateStruct': {'date': '2007-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Partial or complete remission of the vasculitides', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'To study the safety and adverse effects of both regimens', 'timeFrame': 'one year'}, {'measure': 'Microscopic polyangiitis', 'timeFrame': 'one year'}, {'measure': "Wegener's granulomatosis", 'timeFrame': 'one year'}, {'measure': 'Churg-Strauss syndrome', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Systemic ANCA+ vascularizes', 'Relapse', 'Corticosteroids', 'Immunosuppressant', 'Infliximab/rituximab', 'Patients with relapsing or refractory forms of ANCA', 'associated vasculitides Microscopic polyangiitis'], 'conditions': ["Wegener's Granulomatosis", 'Churg-Strauss Syndrome', 'Microscopic Polyangiitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated vasculitides.', 'detailedDescription': "The aim of this study is to compare the efficacy of rituximab versus infliximab in relapsing or refractory forms of ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemic ANCA positive (+) vasculitides\n* Relapsing or refractory vasculitides, resistant to corticosteroids and reference immunosuppressant therapies\n* Age \\>18 years old\n* Written informed consent\n\nExclusion Criteria:\n\n* Newly diagnosed patient\n* Patient that had never received an immunosuppressant before to treat his/her vasculitis\n* Malignancy\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00307593', 'briefTitle': 'RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies', 'orgStudyIdInfo': {'id': 'P020931'}, 'secondaryIdInfos': [{'id': 'AOM02098'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Rituximab', 'interventionNames': ['Drug: Rituximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Infliximab', 'interventionNames': ['Drug: Infliximab']}], 'interventions': [{'name': 'Infliximab', 'type': 'DRUG', 'description': 'Infliximab', 'armGroupLabels': ['2']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': 'Rituximab', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Loïc GUILLEVIN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}}}}