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:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2025-12-25 @ 3:15 AM
NCT ID:
NCT01961505
Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria or European League Against Rheumatism criteria (2009).
* Patients must have moderately to severely active RA,and the DAS-28 score should be from 3.2 to 5.1.
* If taking disease modifying antirheumatic drug (DMARDs)(e.g.Methotrexate), subject must have been on a stable dose for ≥ 3 months prior to randomization.
* If taking non-steroidal anti-inflammatory drugs (NSAIDs), subject must have been on a stable dose for ≥ 4 weeks prior to randomization.
* 16 to 65 years old, having signed the informed consent.
Exclusion Criteria:
* Patients who have skin burst or allergies.
* Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system.
* Patients who have been treated by tripterygium, hormones or biological agents.
* Patients who have not been treated by DMARDs before.
* Patients who are unwilling to comply with all study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01961505
Study Brief:
Protocol Section:
NCT01961505