Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-02 @ 3:40 AM
Study NCT ID:
NCT00144651
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2005-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of MRA in Patients With Rheumatoid Arthritis (RA)
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2005-09-02', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACR 20% responder rate compared to the pre-treatment in the preceding study', 'timeFrame': 'throughout study'}, {'measure': 'Frequency and severity of adverse events and adverse drug reactions', 'timeFrame': 'week0,week4,week8,week12,and LOBS'}], 'secondaryOutcomes': [{'measure': 'Time course of DAS28,compared to the pre-treatment in the preceding study', 'timeFrame': 'week 0,week 4,week 8,week 12, LOBS'}, {'measure': 'Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study', 'timeFrame': 'week 0,week 4,week 8,week 12, LOBS'}, {'measure': 'ACR N AUC compared to the pre-treatment in the preceding study', 'timeFrame': 'week 0,week 4,week 8,week 12, LOBS'}, {'measure': 'Time course of the ACR core set variables compared to the pre-treatment in the preceding study', 'timeFrame': 'week 0,week 4,week 8,week 12, LOBS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.\n* Patients confirmed to have shown the safety in the preceding study.\n\nExclusion Criteria:\n\n* Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug\n* Patients who received any of the following treatments between the start of preceding study and the registration of this study.\n\n 1. Plasma exchange therapy\n 2. Surgical treatment (e.g., operation)'}, 'identificationModule': {'nctId': 'NCT00144651', 'briefTitle': 'Study of MRA in Patients With Rheumatoid Arthritis (RA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chugai Pharmaceutical'}, 'officialTitle': 'An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP', 'orgStudyIdInfo': {'id': 'MRA010JP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: MRA(Tocilizumab)']}], 'interventions': [{'name': 'MRA(Tocilizumab)', 'type': 'DRUG', 'description': '8mg/kg/4 weeks for 1 year', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Takahiro Kakehi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chugai Pharmaceutical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chugai Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}