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Studies

Interventional Recruiting Phase 4

NCT06687551 on ClinicalTrials.gov

JAK Inhibitor Dose TAPering Strategy Study

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

  • Sponsor: Hôpital Rangueil
  • Enrollment: 308 (Estimated)
  • Study start: 2025-06-06 (Actual)
  • Primary completion: 2029-04-01 (Estimated)
  • Study completion: 2029-04-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: This study will take the format of a prospective therapeutic research. The design will be a pragmatic multicentre open-label simple-blinded, non-inferiority randomised controlled trial with two parallel groups, ratio 1:1, comparing the two following groups: 1. JAK inhibitor dose-tapering strategy. 2. JAK inhibitor continuous therapy strategy.
  • Masking: Single (Investigator)
  • PrimaryPurpose: Treatment

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

Conditions

  • Rheumatoid Arthritis (RA

Intervention / Treatment

  • Drug: Baricitinib (LY3009104) 4 mg
  • Drug: filgotinib 200mg/day
  • Drug: Tofacitinib 5 mg twice daily
  • Drug: Upadacitinib 15 MG

Primary Outcome Measures

  • proportion of patients still receiving a JAK-inhibitor (12 post baseline)
    The primary outcome of this study will be the proportion of patients still receiving a JAK-inhibitor and being in CDAI low disease activity at 12 months. The size of the effect will be given in the form of the difference in proportion between the two treatment groups with a two-sided confidence interval at 95%. Non-inferiority will be assessed with this interval. Non-inferiority will be concluded if the lower limit of the 95% confidence interval does not exceed the non-inferiority margin of 10% of the difference in proportion.

Countries

France

Locations and Investigators

  • UH Toulouse, Toulouse, France (Recruiting)
    • ADELINE RUYSSEN WITRAND
  • CHU d'Amiens, Amiens, France (Recruiting)
    • Goeb
  • Hôpital Pellegrin, Bordeaux, France (Recruiting)
    • Richez
  • La Cavale Blanche, Brest, France (Recruiting)
    • Saraux
  • CHU de Clermont-Ferrand, Clermont-Ferrand, France (Recruiting)
    • Tournadre
  • CHU Le Mans, Le Mans, France (Recruiting)
    • Direz
  • Hôpital Saint Philibert, Lille, France (Recruiting)
    • Pascart
  • CHU Dupuytren 2, Limoges, France (Recruiting)
    • PASCALE Vergne-Salle, MD PHD
  • Hôpital Sainte Marguerite, Marseille, France (Recruiting)
    • Pham
  • Hôpital LAPEYRONIE, Montpellier, France (Recruiting)
    • JACQUES MOREL, MD PHD
  • CHRU de Nancy, Nancy, France (Recruiting)
    • Loeuille
  • Hôpital Pasteur 2, Nice, France (Recruiting)
    • CHRISTIAN ROUX, MD PHD
  • Nouvel Hôpital Orléans La Source, Orléans, France (Recruiting)
    • Salliot
  • GH Paris Saint-Joseph, Paris, France (Recruiting)
    • Hayem
  • Groupe hospitalier Pitié-Salpêtrière, Paris, France (Recruiting)
    • BRUNO FAUTREL
  • Hopital Cochin, Paris, France (Recruiting)
    • JEROME AVOUAC
  • Hopital Lariboisière, Paris, France (Recruiting)
    • PASCAL RICHETTE
  • Hopital Saint Antoine, Paris, France (Recruiting)
    • Berenbaum
  • Hôpital Bicêtre, Paris, France (Recruiting)
    • Mariette
  • Hopital Maison Blanche, Reims, France (Recruiting)
    • Salmon
  • CHU de Rouen, Rouen, France (Recruiting)
    • Vittecoq
  • Hopital Nord, Saint-Etienne, France (Recruiting)
    • Marotte
  • Hôpital Hautepierre, Strasbourg, France (Recruiting)
    • Gottenberg
  • CHU de Tours, Tours, France (Recruiting)
    • Goupille