JAK Inhibitor Dose TAPering Strategy Study
Recruiting · NCT06687551 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Toulouse
View the official record on ClinicalTrials.gov →Interventions studied
Baricitinib (LY3009104) 4 mgTofacitinib 5 mg twice dailyUpadacitinib 15 MGfilgotinib 200mg/day
What this trial is about
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
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- will be
- 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
- The non-inclusion criteria will be:
- Concomitant disease needing to be treated by the JAK inhibitor at full-dose (for example inflammatory bowel disease).
- 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 (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.
- 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.
- 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.
Where it is running
24 locations listed.
- CHU d'Amiens - Amiens, France
- Hôpital Pellegrin - Bordeaux, France
- La Cavale Blanche - Brest, France
- CHU de Clermont-Ferrand - Clermont-Ferrand, France
- CHU Le Mans - Le Mans, France
- Hôpital Saint Philibert - Lille, France
- CHU Dupuytren 2 - Limoges, France
- Hôpital Sainte Marguerite - Marseille, France
- Hôpital LAPEYRONIE - Montpellier, France
- CHRU de Nancy - Nancy, France
- Hôpital Pasteur 2 - Nice, France
- Nouvel Hôpital Orléans La Source - Orléans, France
- GH Paris Saint-Joseph - Paris, France
- Groupe hospitalier Pitié-Salpêtrière - Paris, France
- Hopital Cochin - Paris, France
- Hopital Lariboisière - Paris, France
- Hopital Saint Antoine - Paris, France
- Hôpital Bicêtre - Paris, France
- Hopital Maison Blanche - Reims, France
- CHU de Rouen - Rouen, France
- Hopital Nord - Saint-Etienne, France
- Hôpital Hautepierre - Strasbourg, France
- CHU de Tours - Tours, France
- UH Toulouse - Toulouse, Occitanie, France