Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT01224418
Status:
COMPLETED
Last Update Posted:
2010-10-20
First Post:
2010-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate
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': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-19', 'studyFirstSubmitDate': '2010-10-14', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACR20 response rate compared to baseline', 'timeFrame': 'Baseline and up to 6 months', 'description': '(ACR20: 20% improvement in American College of Rheumatology Core Set)'}], 'secondaryOutcomes': [{'measure': 'ACR50 response rate compared to baseline', 'timeFrame': 'Baseline and up to 6 months'}, {'measure': 'ACR70 response rate compared to baseline', 'timeFrame': 'Baseline and up to 6 months'}, {'measure': 'Changes from baseline in 100mm pain VAS (Visual Analogue Scale)', 'timeFrame': 'Baseline and up to 6 months'}, {'measure': 'Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test', 'timeFrame': 'For 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tacrolimus', 'Prograf', 'Calcinurin inhibitor', 'Rheumatoid arthritis(RA)'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with more than 6 months history of rheumatoid arthritis according to ACR criteria\n* Patients who have been treated unsuccessfully to more than single DMARDs including methotrexate at the discretion of investigator\n* ESR ≥ 30 mm/h or CRP ≥ 1.0 mg/dL (ESR: Erythrocyte Sedimentation Rate, CRP: C-Reactive Protein)\n* Patients are required to have at least 3 of 66 joints assessed as swollen\n* Patients are required to have at least 6 of 68 joints assessed as painful with pressure\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study\n* Previous experience of tacrolimus (ointment excluded)\n* Renal impairment or serum creatinine \\> 1.4 mg/dL\n* Liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, SGOT/SGPT \\> 2x upper limit normal\n* Patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:Blood glucose level \\>110mg/dl before the meal and \\>200mg/dl after the meal HbA1c \\> 6.4%\n* Cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications\n* Other investigational drug within last 30 days\n* Patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study'}, 'identificationModule': {'nctId': 'NCT01224418', 'briefTitle': 'A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study', 'orgStudyIdInfo': {'id': 'PRGRA-08-01-KOR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tacrolimus group', 'interventionNames': ['Drug: Tacrolimus']}], 'interventions': [{'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograf', 'FK506'], 'description': 'oral', 'armGroupLabels': ['Tacrolimus group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gyeonggido', 'country': 'South Korea'}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma Korea, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Director', 'oldOrganization': 'Astellas Pharma, Inc'}}}}