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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT06687551
Eligibility Criteria:
The inclusion criteria will be
1. Aged ≥ 18 years at baseline.
2. Rheumatoid arthritis defined by the ACR/EULAR criteria.
3. Treated with a JAK inhibitor, full dose for at least 6 months.
4. The JAK inhibitor is prescribed as monotherapy or combined with a csDMARD with a stable dosage for at least 3 months before inclusion.
5. Being in LDA (CDAI≤10) for at least 6 months.
6. With a CRP level below the laboratory standard within the month before the inclusion visit.
7. Women of childbearing potential (WCBP) must have a negative pregnancy test before starting study
The non-inclusion criteria will be:
1. Concomitant disease needing to be treated by the JAK inhibitor at full-dose (for example inflammatory bowel disease).
2. Patient with a history of JAK-inhibitor dose reduction/spacing before enrollment in the study with the JAK-inhibitor currently being taken.
3. Evidence of flare-up within the last 6 months prior to the inclusion.
4. Patient who received glucocorticoids \> 5mg/day in the 3 months prior the inclusion because of the disease activity of the RA.
5. Patient requiring corticoid joint injections in the 3 months prior to inclusion or with scheduled joint injections, to control disease activity.
6. Patient at risk for complication according to the ANSM (60) (current or past smokers, patients at risk of VTE, cancer or major cardiovascular problems, aged ≥ 65 years) at baseline AND currently taking baricitinib or filgotinib.
7. Patient taking associated bDMARD (including anti-TNF, anti-IL6, anti-CD20, abatacept, anti-IL17, anti-IL12/23, anti-IL23, anti-IL1, anti-BAFF, anti-IL5 pathways).
8. Patient taking immunotherapy for neoplasia.
9. Surgery scheduled in the next 12 months.
10. Fibromyalgia according to the physician's opinion.
11. Anticipated poor compliance with the strategy.
12. Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.
13. Alcohol and/or drug misuse as determined by the investigator.
14. Pregnancy or breastfeeding.
15. Non-affiliation to the French Social Security System.
16. Patient unwilling to sign the informed consent form.
17. Patient under legal protection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06687551
Study Brief:
Protocol Section:
NCT06687551