Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT01511003
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2012-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)
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': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-10', 'studyFirstSubmitDate': '2012-01-04', 'studyFirstSubmitQcDate': '2012-01-12', 'lastUpdatePostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACR20 response rate 6 months post dose', 'timeFrame': 'Baseline and 6 months post dose', 'description': 'ACR20 is 20% improvement in ACR (American College of Rheumatology) core set'}], 'secondaryOutcomes': [{'measure': 'ACR50 response rates at month 6', 'timeFrame': 'Baseline and at month 6', 'description': 'ACR50 is 50% improvement in ACR (American College of Rheumatology) core set'}, {'measure': 'ACR70 response rates at month 6', 'timeFrame': 'Baseline and at month 6', 'description': 'ACR70 is 70% improvement in ACR (American College of Rheumatology) core set'}, {'measure': 'Change in DAS28 from baseline to 6 months', 'timeFrame': 'Baseline and at month 6', 'description': 'DAS (Disease Activity Score in Rheumatoid Arthritis)'}, {'measure': 'Change in bone loss rate from baseline to 6 months', 'timeFrame': 'Baseline and at month 6', 'description': 'comparative factors for bone loss rate: bone mineral densitometry \\[BMD\\], bone turnover marker test'}, {'measure': 'Safety assessed by the incidence of adverse events, vital signs and lab-tests', 'timeFrame': 'For 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['calcineurin inhibitor', 'Prograf', 'Rheumatoid arthritis (RA)', 'Tacrolimus'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=151', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have rheumatoid arthritis for 6 months or longer based on American College of Rheumatology (ACR) diagnostic criteria\n* Subjects who used more than 1 Disease Modifying Antirheumatic Drug (DMARD) including MTX (methotrexate) for 6 months or longer\n* Subjects with ESR (erythrocyte sedimentation rate) ≥ 28mm/h or CRP (C-reactive protein)≥ 1.0 mg/dL\n* Subjects with ≥ 3 swollen joints out of 66 joints assessed\n* Subjects with ≥ 6 tender joints out of 68 joints assessed\n\nExclusion Criteria:\n\n* Pregnant or nursing women, or subjects who plan to become pregnant within 6 months or whose screening test results show pregnancy cannot be ruled out\n* Subjects with previous experience of tacrolimus (excluding external preparations)\n* Subjects with renal dysfunction or with serum creatinin \\> 1.4 mg/dL at screening\n* Following subjects with hepatic dysfunction: viral infection, non-viral infection, hepatic cirrhosis, and Serum Glutamic Oxaloacetic Transaminase / Serum Glutamic Pyruvic Transaminase (SGOT/SGPT) exceeding twice the upper limit of normal at screening\n* Subjects with pancreatitis, uncontrolled diabetes or complication(s) or with HbA1c \\> 6.4% at screening\n* Subjects complicated with hyperkalemia or with serum potassium level \\>5.5 mEq/L at screening\n* Subjects with history of heart disease (ischemic heart disease, arrhythmia requiring treatment, and heart failure), etc or complications\n* Subjects complicated with severe respiratory disease and infection\n* Subjects with history of malignant tumor or complication(s) (However, the subjects who are considered to have no risk of recurrence with malignant tumor untreated for 5 years or longer can enter the study. The subjects who succeeded in treatment for basal cell or squamous cell carcinoma of skin can also enter the study.)\n* Subjects who were treated with other investigational product(s) within 3 months before screening\n* Other subjects who are considered ineligible for the study by the investigator'}, 'identificationModule': {'nctId': 'NCT01511003', 'acronym': 'TREASURE', 'briefTitle': 'A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs', 'orgStudyIdInfo': {'id': 'PRGRA-10-04-KOR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tacrolimus group', 'description': 'oral', 'interventionNames': ['Drug: Tacrolimus']}], 'interventions': [{'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograf'], 'description': 'oral', 'armGroupLabels': ['Tacrolimus group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daejeon', 'country': 'South Korea', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'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': {'type': 'SPONSOR'}}}}