NCT06687551 JAK Inhibitor Dose TAPering Strategy Study
| NCT ID | NCT06687551 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Toulouse |
| Condition | Rheumatoid Arthritis (RA |
| Study Type | INTERVENTIONAL |
| Enrollment | 308 participants |
| Start Date | 2025-06-06 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 308 participants in total. It began in 2025-06-06 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to assess the feasibility of tapering JAK inhibitors in rheumatoid arthritis patients in low disease activity by comparing a group of patients tapering the JAK inhibitor dosage to a group of patients continuing the full-dose. Participants will: * Either take 1. JAK inhibitor dose-tapering strategy. 2. JAK inhibitor continuous therapy strategy. * Visit the clinic once every 3 months for checkups and tests * Keep a diary of their treatment intake and symptoms
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06687551 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Rheumatoid Arthritis (RA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06687551 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06687551 currently recruiting?
Yes, NCT06687551 is actively recruiting participants. Contact the research team at ruyssen-witrand.a@chu-toulouse.fr for enrollment information.
Where is the NCT06687551 trial being conducted?
This trial is being conducted at Toulouse, France, Amiens, France, Bordeaux, France, Brest, France and 11 additional locations.
Who is sponsoring the NCT06687551 clinical trial?
NCT06687551 is sponsored by University Hospital, Toulouse. The trial plans to enroll 308 participants.
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