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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 October 2021
• Main ID: NCT03254966
• Date of registration: 15/08/2017
• Prospective Registration: Yes
• Primary sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Public title: Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients
• Scientific 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
• Date of first enrolment: November 24, 2017
• Target sample size: 194
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03254966
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Xiaofeng Zeng
• Affiliation: Peking Union Medical College Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Placebo

Drug: SHR0302

Primary Outcome(s)

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

Secondary Outcome(s)

Percentage of subjects achieving DAS28-3(CRP)<2.6 at Week 24 [Time Frame: Baseline - Week 24]

Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 24 [Time Frame: Baseline - Week 24]

Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 12 [Time Frame: Baseline - Week 12]

Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 24 [Time Frame: Baseline - Week 24]

Percentage of subjects achieving an American College of Rheumatology (ACR)50 response at Week 12 [Time Frame: Baseline - Week 12]

Percentage of subjects achieving an American College of Rheumatology (ACR)70 response at Week 12 [Time Frame: Baseline - Week 12]

Percentage of subjects achieving DAS28-3(CRP)<2.6 at Week 12 [Time Frame: Baseline - Week 12]

Change from baseline in the Health Assessment Questionaire (HAQ-DI) at week 24 [Time Frame: Baseline - Week 24]

Percentage of subjects achieving an American College of Rheumatology (ACR)20 response at Week 24 [Time Frame: Baseline - Week 24]

Secondary ID(s)

SHR0302-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors