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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT05305066
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years;
* Arthritis that fulfills the 2010 ACR/EULAR classification criteria for RA;
* Failure to standard conventional synthetic DMARDs and eligible for second-line b/tsDMARDs (Sub-study 1) or failure to at least one TNF inhibitor and eligible for third-line b/tsDMARDs (Sub-study 2).
Exclusion Criteria:
* Prior b/tsDMARDs for Sub-study 1 or prior b/tsDMARDs other than TNF inhibitors for Sub-study 2;
* Contraindication to b/tsDMARD therapy, such as active infection or untreated latent TB, current malignancy, severe organ dysfunction, history of VTE (unless anticoagulated), high risk of cardiovascular disease, pregnancy/lactation;
* Overlap with another inflammatory disease requiring specific immunosuppressive therapy, such as lupus nephritis;
* Unable to provide consent or complete forms (alone or with assistance) in English or French
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05305066
Study Brief:
Protocol Section:
NCT05305066