Clinical trial NCT03254966: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-21
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to severe active 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

Primary outcomes:
measure: Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12
timeFrame: Baseline - Week 12
Secondary outcomes:
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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xiaofeng Zeng
role: PRINCIPAL_INVESTIGATOR
References: