Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-06 @ 6:23 PM
Study NCT ID:
NCT00576433
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2007-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
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': 'D008727', 'term': 'Methotrexate'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2007-12-18', 'studyFirstSubmitQcDate': '2007-12-18', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AEs, including infusion-related adverse events', 'timeFrame': 'For 48 weeks after initial treatment'}], 'secondaryOutcomes': [{'measure': 'Safety of re-treatment (AEs)', 'timeFrame': 'For 24 weeks after re-treatment.'}, {'measure': 'Laboratory parameters, vital signs.', 'timeFrame': 'Throughout study'}, {'measure': 'ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT.', 'timeFrame': 'For 48 weeks after initial treatment.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, 18-80 years of age;\n* moderate to severe active rheumatoid arthritis;\n* inadequate response to previous or current treatment with 1 anti-TNF agent;\n* receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for \\>=4 weeks.\n\nExclusion Criteria:\n\n* previous treatment with MabThera;\n* use of an anti-TNF alpha agent within 8 weeks of study start;\n* concurrent treatment with any DMARD other than methotrexate;\n* active infection, or history of serious recurrent or chronic infection.'}, 'identificationModule': {'nctId': 'NCT00576433', 'briefTitle': 'A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor', 'orgStudyIdInfo': {'id': 'ML21271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Methotrexate', 'Drug: rituximab [MabThera/Rituxan]']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'As prescribed', 'armGroupLabels': ['1']}, {'name': 'rituximab [MabThera/Rituxan]', 'type': 'DRUG', 'description': '1000mg iv on days 1 and 15', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '454076', 'city': 'Chelyabinsk', 'country': 'Russia', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '664047', 'city': 'Irkutsk', 'country': 'Russia', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'zip': '420012', 'city': "Kazan'", 'country': 'Russia', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '680009', 'city': 'Khabarovsk', 'country': 'Russia', 'geoPoint': {'lat': 48.46204, 'lon': 135.0971}}, {'zip': '628011', 'city': 'Khanty-Mansiysk', 'country': 'Russia', 'geoPoint': {'lat': 61.00187, 'lon': 69.02728}}, {'zip': '305007', 'city': 'Kursk', 'country': 'Russia', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603126', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '630099', 'city': 'Novosibirsk', 'country': 'Russia', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '630117', 'city': 'Novosibirsk', 'country': 'Russia', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '195067', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '625023', 'city': 'Tyumen', 'country': 'Russia', 'geoPoint': {'lat': 57.15222, 'lon': 65.52722}}, {'zip': '450005', 'city': 'Ufa', 'country': 'Russia', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '690050', 'city': 'Vladivostok', 'country': 'Russia', 'geoPoint': {'lat': 43.10562, 'lon': 131.87353}}, {'zip': '394066', 'city': 'Voronezh', 'country': 'Russia', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'zip': '150062', 'city': 'Yaroslavl', 'country': 'Russia', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '620102', 'city': 'Yekaterinburg', 'country': 'Russia', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}