Back to resultsStudy of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR0302
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- male or female subjects who are 18 - 70 (inclusive) years of age on the day of signing informed consent
- have a diagnosis of RA meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III
- 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
- 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
- Body mass index (BMI = weight/height squared (kg/m2)) within the range of 18 to 35,
Exclusion Criteria:
- current or previous RA treatment with a jak inhibitor
- current or previous RA treatment with a biologic DMARD
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
SHR0302 dose level 1
SHR0302 dose level 2
SHR0302 dose level 3
SHR0302 dose level 4
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12
Secondary Outcome Measures
Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24
Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12
Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24
Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12
Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24
Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 12
Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 24
Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 12
Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 24
Full Information
NCT ID
NCT03254966
First Posted
August 15, 2017
Last Updated
September 24, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03254966
Brief Title
Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 24, 2017 (Actual)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
October 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to severe active rheumatoid arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHR0302 dose level 1
Arm Type
Experimental
Arm Title
SHR0302 dose level 2
Arm Type
Experimental
Arm Title
SHR0302 dose level 3
Arm Type
Experimental
Arm Title
SHR0302 dose level 4
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR0302
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12
Time Frame
Baseline - Week 12
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24
Time Frame
Baseline - Week 24
Title
Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12
Time Frame
Baseline - Week 12
Title
Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24
Time Frame
Baseline - Week 24
Title
Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12
Time Frame
Baseline - Week 12
Title
Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24
Time Frame
Baseline - Week 24
Title
Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 12
Time Frame
Baseline - Week 12
Title
Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 24
Time Frame
Baseline - Week 24
Title
Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 12
Time Frame
Baseline - Week 12
Title
Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 24
Time Frame
Baseline - Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male or female subjects who are 18 - 70 (inclusive) years of age on the day of signing informed consent
have a diagnosis of RA meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III
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
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
Body mass index (BMI = weight/height squared (kg/m2)) within the range of 18 to 35,
Exclusion Criteria:
current or previous RA treatment with a jak inhibitor
current or previous RA treatment with a biologic DMARD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients
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