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 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT04821050
Eligibility Criteria:
Inclusion Criteria:
* 18-65 years of age at screening
* Met the American College of Rheumatology criteria (2010) for RA
* Active mild to moderate RA (defined as 3.2 \< DAS28-CRP\< 5.1) naïve to any medication; or refractory RA who demonstrated an inadequate response or loss of response to 2 or more conventional synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) after treatment for at least 6 months.
Exclusion Criteria:
* Any severe chronic or uncontrolled comorbid disease, such as important organ failure, degree II and III heart block, clinically significant cardiovascular disease, severe infection, tumor, etc;
* Combined with other connective tissue diseases
* Cognitive impairment and can't cooperate
* Pregnancy or breastfeeding
* Bleeding or coagulation disorders
* Localized skin infections
* Intra-articular corticosteroid or pulse steroid within 2 weeks preceding the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04821050
Study Brief:
Protocol Section:
NCT04821050