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NOT YET RECRUITING
NCT07718529
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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