Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-29 @ 2:00 AM
Study NCT ID:
NCT01211834
Status:
COMPLETED
Last Update Posted:
2010-11-03
First Post:
2010-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe 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': 'C502936', 'term': 'tocilizumab'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}], 'ancestors': [{'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-01', 'studyFirstSubmitDate': '2010-09-29', 'studyFirstSubmitQcDate': '2010-09-29', 'lastUpdatePostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with ACR20 responses', 'timeFrame': '24weeks', 'description': 'Proportion of patients with ACR20 responses at post therapy'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with ACR50 and ACR70 responses at post therapy', 'timeFrame': '24weeks'}, {'measure': 'Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin', 'timeFrame': '24weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '32508063', 'type': 'DERIVED', 'citation': 'Choi IA, Sagawa A, Lee EY, Lee EB, Song YW. Tocilizumab Increases Body Weight and Serum Adipokine Levels in Patients with Rheumatoid Arthritis Independently of Their Treatment Response: a Retrospective Cohort Study. J Korean Med Sci. 2020 Jun 8;35(22):e155. doi: 10.3346/jkms.2020.35.e155.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in patients with moderate to severe active RA and inadequate response to current DMARD treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, \\>= 18 years of age\n* Active RA of \\> 6monts duration\n* Received permitted DMARDs each at a stable dose for at least 8 weeks\n\nExclusion Criteria:\n\n* Rheumatic autoimmune disease other than RA\n* Significant systemic involvement secondary to RA\n* ALT or AST \\> ULNā
¹1.5\n* Platelet count \\< 100,000/mm3\n* Hemoglobin \\< 8.5 g/dL\n* White blood cells \\< 3,000/mm3\n* Absolute neutrophil count \\< 2,000/mm3\n* Absolute lymphocyte count \\< 500/mm3'}, 'identificationModule': {'nctId': 'NCT01211834', 'briefTitle': 'Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'JW Pharmaceutical'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy', 'orgStudyIdInfo': {'id': 'CWP-TCZ301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tocilizumab 8mg/kg+DMARDs', 'interventionNames': ['Drug: tocilizumab', 'Drug: DMARDs']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo+DMARDs', 'interventionNames': ['Drug: Placebo', 'Drug: DMARDs']}], 'interventions': [{'name': 'tocilizumab', 'type': 'DRUG', 'description': 'intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks', 'armGroupLabels': ['Tocilizumab 8mg/kg+DMARDs']}, {'name': 'DMARDs', 'type': 'DRUG', 'description': 'Methotrexate(MTX) and/or 1 DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)', 'armGroupLabels': ['Tocilizumab 8mg/kg+DMARDs']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'intravenously over 1 hour infusion every 4weeks', 'armGroupLabels': ['Placebo+DMARDs']}, {'name': 'DMARDs', 'type': 'DRUG', 'description': 'Methotrexate(MTX) and/or 1 DMARDs', 'armGroupLabels': ['Placebo+DMARDs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National Univ. Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JW Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Professor. Young-Wook song', 'oldOrganization': 'Seoul National Univ. Hospital'}}}}