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Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis
Sponsor: Assistance Publique Hopitaux De Marseille
Summary
This phase IV, multicenter, open-label randomized controlled trial will evaluate whether a JAK inhibitor discontinuation strategy is superior to standard maintenance therapy in adult patients with ulcerative colitis who are in sustained deep remission. A total of 224 patients treated with tofacitinib, upadacitinib, or filgotinib will be randomized to either treatment withdrawal or continuation of maintenance therapy and followed for 104 weeks. The primary objective is to compare safety, efficacy, and patient satisfaction at Week 52, while secondary objectives include assessment of remission maintenance, quality of life, treatment exposure, endoscopic outcomes, and relapse rates
Official title: Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
224
Start Date
2027-01
Completion Date
2031-01
Last Updated
2026-07-22
Healthy Volunteers
No
Conditions
Interventions
treatment withdrawal
the patients will stop their treatment, as long as possible until symptom reappearance, if any
Locations (22)
CHU Amiens-Picardie
Amiens, France
Centre Hospitalier d'Avignon
Avignon, France
CHRU Besançon
Besançon, France
CHU Bordeaux
Bordeaux, France
CHU Clermont Ferrand
Clermont-Ferrand, France
Chu Lille
Lille, France
HCL
Lyon, France
AP-HM hopital Nord
Marseille, France
CHU Montpellier
Montpellier, France
CHRU Nancy
Nancy, France
CHU Nantes
Nantes, France
CHU Nice
Nice, France
CHU Nîmes
Nîmes, France
Hôpital Beaujon
Paris, France
Hôpital Bicêtre
Paris, France
Hôpital Henri-Mondor
Paris, France
Institut des MICI
Paris, France
Chu Rennes
Rennes, France
CHU Rouen
Rouen, France
CHU St Etienne
Saint-Etienne, France
Chits Toulon
Toulon, France
CHU Toulouse
Toulouse, France