Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 7:14 PM
Study NCT ID:
NCT00144560
Status:
COMPLETED
Last Update Posted:
2008-12-15
First Post:
2005-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction Study of MRA in Patient 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-11', 'studyFirstSubmitDate': '2005-09-02', 'studyFirstSubmitQcDate': '2005-09-02', 'lastUpdatePostDateStruct': {'date': '2008-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '20% improvement based on the ACR criteria compared with the baseline value.', 'timeFrame': 'throughout study'}], 'secondaryOutcomes': [{'measure': 'Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.', 'timeFrame': 'Week 0,Week 1, Week 2'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is an open-label, clinical pharmacology study to investigate drug-drug interaction in patients with RA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Patients who are diagnosed with RA according to the 1987 American College of Rheumatology (ACR) classification criteria\n* Patients who contracted RA at least 6 months prior\n\nExclusion criteria\n\n* Patients with Class IV Steinbrocker functional impairment at enrollment.\n* Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept and have been receiving treatment with leflunomide, within 12 weeks before initiation of treatment with the probe drug'}, 'identificationModule': {'nctId': 'NCT00144560', 'briefTitle': 'Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chugai Pharmaceutical'}, 'officialTitle': 'An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA', 'orgStudyIdInfo': {'id': 'MRA220JP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRA(Tocilizumab)', 'type': 'DRUG'}]}, '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'}}}}