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 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT05516758
Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of adult onset rheumatoid arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria
* Have moderately-to-severely active RA, at screening and baseline, defined by the presence of
* ≥6 swollen joints based on 66 joint count, and
* ≥6 tender joints based on 68 joint count.
* Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD ( bDMARD), or targeted synthetic DMARD (tsDMARD) treatment.
Exclusion Criteria:
* Have Class IV RA according to ACR revised criteria.
* Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to
* poorly controlled diabetes or hypertension
* chronic kidney disease stage IIIb, IV, or V
* symptomatic heart failure according to New York Heart Association Class II, III, or IV
* myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization
* severe chronic pulmonary disease, for example, requiring oxygen therapy
* major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to,
* systemic lupus erythematosus
* psoriatic arthritis
* axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis
* reactive arthritis
* gout
* scleroderma
* polymyositis
* dermatomyositis
* active fibromyalgia, or
* multiple sclerosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05516758
Study Brief:
Protocol Section:
NCT05516758