Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: SHR0302

Study type: Interventional

Funder types: Industry

Identifiers

NCT03254966

SHR0302-201

Details and patient eligibility

About

To evaluate the safety and efficacy of SHR0302 tablets (SHR0302) in subjects with moderate to severe active rheumatoid arthritis.

Enrollment: 194 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

194 participants in 5 patient groups, including a placebo group

SHR0302 dose level 1

Experimental group

Treatment:

Drug: SHR0302

SHR0302 dose level 2

Experimental group

Treatment:

Drug: SHR0302

SHR0302 dose level 3

Experimental group

Treatment:

Drug: SHR0302

SHR0302 dose level 4

Experimental group

Treatment:

Drug: SHR0302

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo