Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT03254966
Status:
COMPLETED
Last Update Posted:
2021-09-30
First Post:
2017-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients
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': 'C000615713', 'term': 'ivarmacitinib'}]}}, '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': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-24', 'studyFirstSubmitDate': '2017-08-15', 'studyFirstSubmitQcDate': '2017-08-18', 'lastUpdatePostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12', 'timeFrame': 'Baseline - Week 12'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24', 'timeFrame': 'Baseline - Week 24'}, {'measure': 'Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12', 'timeFrame': 'Baseline - Week 12'}, {'measure': 'Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24', 'timeFrame': 'Baseline - Week 24'}, {'measure': 'Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12', 'timeFrame': 'Baseline - Week 12'}, {'measure': 'Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24', 'timeFrame': 'Baseline - Week 24'}, {'measure': 'Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 12', 'timeFrame': 'Baseline - Week 12'}, {'measure': 'Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 24', 'timeFrame': 'Baseline - Week 24'}, {'measure': 'Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 12', 'timeFrame': 'Baseline - Week 12'}, {'measure': 'Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 24', 'timeFrame': 'Baseline - Week 24'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to severe active rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female subjects who are 18 - 70 (inclusive) years of age on the day of signing informed consent\n* have a diagnosis of RA meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III\n* have ≥6 swollen joints (from a 66-joint count) and ≥8 tender joints (from a 68-joint count) at Screening and at Baseline, Screening serum c-reactive protein (CRP)or hsCRP \\> 1.2 x upper limit of laboratory normal range (ULN),or erythrocyte sedimentation rate (ESR) \\> 28 mm/h\n* have not used any disease modifying anti-rheumatic drug (DMARD) or have an inadequate response to one or more kinds of conditional DMARDs (methotrexate, leflunomide, Chloroquine, hydroxychloroquine, sulfasalazine, minocycline, penicillamine, auranofin or injection gold preparation, and iguratimod) due to lack of efficacy or toxicity, and have agreed to be washed out from these conditional DMARDs for a period of at least 7 t1/2s prior to randomization, with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to randomization\n* Body mass index (BMI = weight/height squared (kg/m2)) within the range of 18 to 35,\n\nExclusion Criteria:\n\n* current or previous RA treatment with a jak inhibitor\n* current or previous RA treatment with a biologic DMARD'}, 'identificationModule': {'nctId': 'NCT03254966', 'briefTitle': 'Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'SHR0302-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR0302 dose level 1', 'interventionNames': ['Drug: SHR0302']}, {'type': 'EXPERIMENTAL', 'label': 'SHR0302 dose level 2', 'interventionNames': ['Drug: SHR0302']}, {'type': 'EXPERIMENTAL', 'label': 'SHR0302 dose level 3', 'interventionNames': ['Drug: SHR0302']}, {'type': 'EXPERIMENTAL', 'label': 'SHR0302 dose level 4', 'interventionNames': ['Drug: SHR0302']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SHR0302', 'type': 'DRUG', 'description': 'Oral tablets', 'armGroupLabels': ['SHR0302 dose level 1', 'SHR0302 dose level 2', 'SHR0302 dose level 3', 'SHR0302 dose level 4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral tablets', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xiaofeng Zeng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}