JAK inhibitor tapering strategy in rheumatoid arthritis patients with low disease activity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, phase 4 study explores the feasibility of tapering JAK inhibitors in adults with rheumatoid arthritis who have maintained low disease activity. Participants are randomized to either a dose-tapering strategy or continue on the full-dose therapy, with follow-up visits every three months and symptom diaries to capture outcomes. Eligible patients have been on a JAK inhibitor for at least six months and are in low disease activity (CDAI ≤ 10) with stable treatment regimens. The trial will assess safety, disease control, and potential reductions in adverse events or costs associated with down-titration. Multiple JAK inhibitors are included, and enrollment is centered at institutions in Toulouse, Amiens, and Bordeaux.

Why it matters

Who can join: the full rules

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.

Where it's running

• UH Toulouse
  Toulouse, Occitanie, France Recruiting
• CHU d'Amiens
  Amiens, France Recruiting
• Hôpital Pellegrin
  Bordeaux, France Recruiting
• La Cavale Blanche
  Brest, France Recruiting
• CHU de Clermont-Ferrand
  Clermont-Ferrand, France Recruiting
• CHU Le Mans
  Le Mans, France Recruiting

Study contacts

• Study coordinator: Adeline RUYSSEN-WITRAND, MD
• Email: ruyssen-witrand.a@chu-toulouse.fr
• Phone: 05 61 77 56 26

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.