Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT03254966
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03254966
Study Brief:
Protocol Section:
NCT03254966