Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT00963703
Status:
COMPLETED
Last Update Posted:
2012-03-20
First Post:
2009-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-19', 'studyFirstSubmitDate': '2009-08-20', 'studyFirstSubmitQcDate': '2009-08-20', 'lastUpdatePostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis', 'timeFrame': 'Biopsies of inflamed joint at beginning and at week 8 of study'}], 'secondaryOutcomes': [{'measure': 'To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells', 'timeFrame': 'Collected at beginning of study and week 8'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells.\n\nThis will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with documented rheumatoid arthritis by ACR criteria\n* Disease duration \\< 5 years\n* May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination\n* Tender joint count \\>= 6, swollen joint count \\>= 6, and one must be a knee\n* Corticosteroids \\<= 10 mg per day permitted on stable doses for at least 4 weeks\n* Patients must consent to 2 arthroscopic synovial biopsy procedures\n\nExclusion Criteria:\n\n* History of severe allergic or anaphylactic reactions to monoclonal antibodies\n* Previous treatment with Rituximab\n* Previous treatment with Arava\n* Injected with steroids within 4 weeks of day 1 of study\n* Treatment with any investigational agent within 4 weeks of day of study\n* Any severe or significant medical condition or disease or known active infection\n* Pregnancy or nursing at present'}, 'identificationModule': {'nctId': 'NCT00963703', 'briefTitle': 'Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes', 'orgStudyIdInfo': {'id': 'B2007:160'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab', 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'description': 'Rituximab 1000 mg Intravenously day 1 and day 15', 'armGroupLabels': ['Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3A 1M4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Arthritis Centre, University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. Hani El-Gabalawy', 'oldOrganization': 'Arthritis Centre, Unversity of Manitoba'}}}}