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NCT06687551RecruitingPhase 4

JAK Inhibitor Dose TAPering Strategy Study

JAK Inhibitor Dose TAPering Strategy Study in Low Disease Activity Rheumatoid Arthritis Patients

Source: ClinicalTrials.gov · Last updated 7 Aug 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
308 (estimated)
First submitted
29 Oct 2024
Start date
6 Jun 2025
Primary completion date
1 Apr 2029
Lead sponsor
University Hospital, Toulouse
NCT number
NCT06687551
EU CT number
2023-509788-25-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 308
  • From 6 Jun 2025 to the primary completion date, 1 Apr 2029
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • The 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire Amiens Picardie
Coordinator of this site? Confirm its status
Amiens Cedex 1FranceRecruiting
Centre hospitalier Universitaire de Bordeaux
Coordinator of this site? Confirm its status
BordeauxFranceRecruiting
Centre Hospitalier Regional Et Universitaire De Brest
Coordinator of this site? Confirm its status
Brest Cedex 2FranceRecruiting
Centre Hospitalier Regional Universitaire De Tours
Coordinator of this site? Confirm its status
Chambray Les ToursFranceRecruiting
University Hospital Of Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont Ferrand Cedex 1FranceRecruiting
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Le Kremlin-BicetreFranceRecruiting
Centre Hospitalier Le Mans
Coordinator of this site? Confirm its status
Le Mans Cedex 9FranceRecruiting
Centre Hospitalier Et Universitaire de Limoges
Coordinator of this site? Confirm its status
LimogesFranceRecruiting
Groupement Des Hopitaux De L'Institut Catholique De Lille
Coordinator of this site? Confirm its status
Lomme CedexFranceRecruiting
Assistance Publique Hôpitaux de Marseille
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
Centre Hospitalier Universitaire De Montpellier
Coordinator of this site? Confirm its status
Montpellier Cedex 5FranceRecruiting
Centre Hospitalier Universitaire de Nice
Coordinator of this site? Confirm its status
NiceFranceRecruiting
Centre Hospitalier Regional D'orleans
Coordinator of this site? Confirm its status
Orleans Cedex 2FranceRecruiting
Assistance Publique Hopitaux de Paris
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Paris Cedex 10FranceRecruiting
Assistance Publique Hopitaux De Paris
Coordinator of this site? Confirm its status
Paris Cedex 13FranceRecruiting
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Coordinator of this site? Confirm its status
Paris Cedex 14FranceRecruiting
Centre Hospitalier Universitaire Reims
Coordinator of this site? Confirm its status
ReimsFranceRecruiting
CHU De Rouen
Coordinator of this site? Confirm its status
Rouen CedexFranceRecruiting
Centre Hospitalier Universitaire de Saint Etienne
Coordinator of this site? Confirm its status
Saint-Priest-en-JarezFranceRecruiting
Les Hopitaux Universitaires De Strasbourg
Coordinator of this site? Confirm its status
Strasbourg Cedex 2FranceRecruiting
Centre Hospitalier Universitaire de Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
CHRU De Nancy
Coordinator of this site? Confirm its status
Vandoeuvre Les Nancy CedexFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.