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

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

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Placebo; Drug: SHR0302

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100032
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral tablets
Experimental: SHR0302 dose level 1	Drug: SHR0302; Oral tablets
Experimental: SHR0302 dose level 2	Drug: SHR0302; Oral tablets
Experimental: SHR0302 dose level 3	Drug: SHR0302; Oral tablets
Experimental: SHR0302 dose level 4	Drug: SHR0302; Oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 12	Baseline - Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24	Baseline - Week 24
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 DAS28-3（CRP）<2.6 at Week 12	Baseline - Week 12
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2017
• Primary Completion (Actual): April 16, 2019
• Study Completion (Actual): October 12, 2019

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: SHR0302-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No