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JAK inhibitor dose TAPering strategy study in low disease activity rheumatoid arthritis patients.
EU CTIS ID: 2023-509788-25-00
What this study is testing
to compare a dose-tapering strategy versus therapy continuation in rheumatoid arthritis patients in low disease activity treated with JAK inhibitors on the risk of losing low disease activity despite rescue therapy at 12 months
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Aged ≥ 18 years at baseline
- Rheumatoid arthritis defined by the ACR/EULAR criteria.
- Treated with a JAK inhibitor, full dose for at least 6 months.
- The JAK inhibitor is prescribed as monotherapy or combined with a csDMARD with a stable dosage for at least 3 months before inclusion.
- Being in LDA (CDAI≤10) for at least 6 months.
- With a CRP level below the laboratory standard within the month before the inclusion visit.
You likely can't join if
- Concomitant disease needing to be treated by the JAK inhibitor at full-dose (for example inflammatory bowel disease).
- Fibromyalgia according to the physician’s opinion.
- Anticipated poor compliance with the strategy.
- Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.
- Alcohol and/or drug misuse as determined by the investigator.
- Pregnancy or breastfeeding.
See the full eligibility criteria
- Aged ≥ 18 years at baseline
- Rheumatoid arthritis defined by the ACR/EULAR criteria.
- Treated with a JAK inhibitor, full dose for at least 6 months.
- The JAK inhibitor is prescribed as monotherapy or combined with a csDMARD with a stable dosage for at least 3 months before inclusion.
- Being in LDA (CDAI≤10) for at least 6 months.
- With a CRP level below the laboratory standard within the month before the inclusion visit.
- Women of childbearing potential (WCBP) must have a negative pregnancy test before starting study
- Concomitant disease needing to be treated by the JAK inhibitor at full-dose (for example inflammatory bowel disease).
- Fibromyalgia according to the physician’s opinion.
- Anticipated poor compliance with the strategy.
- Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.
- Alcohol and/or drug misuse as determined by the investigator.
- Pregnancy or breastfeeding.
- Non-affiliation to the French Social Security System.
- Patient unwilling to sign the informed consent form
- Patient under legal protection.
- Patient with a history of JAK-inhibitor dose reduction/spacing before enrollment in the study with the JAK-inhibitor currently being taken.
- Evidence of flare-up within the last 6 months prior to the inclusion.
- Patient who received glucocorticoids > 5mg/day in the 3 months prior the inclusion because of the disease activity of the RA.
- Patient requiring corticoid joint injections in the 3 months prior to inclusion or with scheduled joint injections, to control disease activity.
- Patient at risk for complication according to the ANSM (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.
- 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).
- Patient taking immunotherapy for neoplasia.
- Surgery scheduled in the next 12 months.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.