Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT03605251
Status:
COMPLETED
Last Update Posted:
2020-08-17
First Post:
2018-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-28', 'releaseDate': '2023-10-09'}, {'resetDate': '2024-10-10', 'releaseDate': '2024-06-28'}, {'resetDate': '2025-02-04', 'releaseDate': '2025-01-09'}], 'estimatedResultsFirstSubmitDate': '2023-10-09'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-14', 'studyFirstSubmitDate': '2018-07-03', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants achieving American College of Rheumatology 20% (ACR20) response', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants who achieve ACR20 response', 'timeFrame': 'Up to Week 36, except for Week 12'}, {'measure': 'Proportion of participants achieving American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) response', 'timeFrame': 'Up to Week 36'}, {'measure': 'Proportion of participants who achieve DAS28-hs C-ReactivePprotein (CRP) and DAS28-Erythrocyte Sedimentation Rate (ESR) for remission', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change from baseline in DAS28-CRP and DAS28-ESR score', 'timeFrame': 'Up to Week 36'}, {'measure': 'Proportion of participants who achieve Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) for remission', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change from baseline in CDAI and SDAI score', 'timeFrame': 'Up to Week 36'}, {'measure': 'Change from baseline in patient assessment score of arthritis pain', 'timeFrame': 'Up to Week 36'}, {'measure': 'Change from baseline in patient global assessment score of arthritis', 'timeFrame': 'Up to Week 36'}, {'measure': "Change from baseline in physician's global assessment score of arthritis", 'timeFrame': 'Up to Week 36'}, {'measure': 'Change from baseline in modified total sharp score', 'timeFrame': 'Baseline, Week 2, 4, 12'}, {'measure': 'Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels', 'timeFrame': 'Up to Week 36'}, {'measure': 'Change from baseline in rheumatoid factor levels', 'timeFrame': 'Up to Week 36'}, {'measure': 'Maximum observed plasma concentration for TAS5315', 'timeFrame': 'Baseline, Week 2, 4, 12'}, {'measure': 'Time to reach the maximum plasma concentration for TAS5315', 'timeFrame': 'Baseline, Week 2, 4, 12'}, {'measure': 'Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for TAS5315', 'timeFrame': 'Baseline, Week 2, 4, 12'}, {'measure': 'Incidence of adverse events and side effects as safety', 'timeFrame': 'Up to Week 36'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '37217273', 'type': 'DERIVED', 'citation': "Takeuchi T, Tanaka S, Murata M, Tanaka Y. Irreversible covalent Bruton's tyrosine kinase inhibitor, TAS5315 versus placebo in rheumatoid arthritis patients with inadequate response to methotrexate: a randomised, double-blind, phase IIa trial. Ann Rheum Dis. 2023 Aug;82(8):1025-1034. doi: 10.1136/ard-2022-223759. Epub 2023 May 22."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of TAS5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a diagnosis of RA according to 2010 ACR/ EULAR rheumatoid arthritis (RA) classification criteria\n* Have been treated with methotrexate (MTX) for at least 90 days prior to screening, and must be on a stable dose between 8 and 16 mg/week for at least 56 days prior to screening.\n* Have an inadequate response to MTX\n* Have a minimum of 6 swollen and 6 tender joints from 66/68 joint count\n* Have hsCRP of ≥ 0.6 mg/dL\n\nExclusion Criteria:\n\n* Have been treated with conventional synthetic disease-modifying anti-rheumatic drug, except for MTX, within 28 days prior to randomization\n* Have an inadequate response to biologic disease-modifying anti-rheumatic drug or Have been treated with 2 biologic treatment\n* Have been treated with Janus Kinase inhibitors or other Bruton's Tyrosine Kinase inhibitors\n* Have a positive result for hepatitis B surface antigen/antibody, hepatitis B core antibody, hepatitis C virus antibody or human immunodeficiency virus antigen/antibody at screening\n* Have been treated with Oral steroids at dose above 10 mg/day of prednisone or prednisone equivalents\n* Have a diagnosis of Felty's syndrome\n* Have a positive result of the QuantiFERON®-tuberculosis (TB) Gold test or a T-spot ®-TB test at screening\n* Have a positive result of β-D-glucan at screening"}, 'identificationModule': {'nctId': 'NCT03605251', 'briefTitle': 'Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate', 'orgStudyIdInfo': {'id': '10063030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TAS5315 low dose group', 'description': 'TAS5315 low dose and Methotrexate as specified', 'interventionNames': ['Drug: TAS5315 low dose']}, {'type': 'EXPERIMENTAL', 'label': 'TAS5315 high dose group', 'description': 'TAS5315 high dose and Methotrexate as specified', 'interventionNames': ['Drug: TAS5315 high dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo and Methotrexate as specified', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'TAS5315 low dose', 'type': 'DRUG', 'description': 'Oral administration for 12 or 36 weeks', 'armGroupLabels': ['TAS5315 low dose group']}, {'name': 'TAS5315 high dose', 'type': 'DRUG', 'description': 'Oral administration for 12 or 36 weeks', 'armGroupLabels': ['TAS5315 high dose group']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Oral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group)', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Taiho Pharmaceutical Co., Ltd selected site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Taiho Pharmaceutical Co., Ltd.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taiho Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-10-09', 'type': 'RELEASE'}, {'date': '2024-03-28', 'type': 'RESET'}, {'date': '2024-06-28', 'type': 'RELEASE'}, {'date': '2024-10-10', 'type': 'RESET'}, {'date': '2025-01-09', 'type': 'RELEASE'}, {'date': '2025-02-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Taiho Pharmaceutical Co., Ltd.'}}}}