Rheumatoid Arthritis
Conditions
Brief summary
To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to severe active rheumatoid arthritis.
Interventions
DRUGSHR0302
Oral tablets
DRUGPlacebo
Oral tablets
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12 | Baseline - Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12 | Baseline - Week 12 |
| Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24 | Baseline - Week 24 |
| Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12 | Baseline - Week 12 |
| Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24 | Baseline - Week 24 |
| Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24 | Baseline - Week 24 |
| Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 24 | Baseline - Week 24 |
| Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 12 | Baseline - Week 12 |
| Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 24 | Baseline - Week 24 |
| Percentage of subjects achieving DAS28-3（CRP）<2.6 at Week 12 | Baseline - Week 12 |
Countries
China
Outcome results
None listed