Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-10 @ 10:31 AM
Study NCT ID:
NCT00144534
Status:
COMPLETED
Last Update Posted:
2009-12-23
First Post:
2005-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-21', 'studyFirstSubmitDate': '2005-09-02', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria', 'timeFrame': 'throughout study'}, {'measure': 'Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions', 'timeFrame': 'throughout study'}, {'measure': 'Pharmacokinetics of the serum MRA concentration', 'timeFrame': '0W,4W,8W,12W,LOBS'}], 'secondaryOutcomes': [{'measure': 'Efficacy:time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set', 'timeFrame': '0W,4W,8W,12W,LOBS'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA213JP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n* Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.\n* In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.\n\nExclusion criteria\n\n* Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug\n* Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug\n* Have not been registered by 3 months after the full code-breaking of the preceding study\n* Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study\n* Treated surgically (except for local surgery) within 4 weeks before administration of the study drug"}, 'identificationModule': {'nctId': 'NCT00144534', 'briefTitle': 'Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chugai Pharmaceutical'}, 'officialTitle': 'An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JP', 'orgStudyIdInfo': {'id': 'MRA215JP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: MRA (Tocilizumab)']}], 'interventions': [{'name': 'MRA (Tocilizumab)', 'type': 'DRUG', 'description': '8mg/kg/4 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Takahiro Kakehi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chugai Pharmaceutical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chugai Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chugai Pharmaceutical', 'oldOrganization': 'Chugai Pharmaceutical'}}}}