Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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

Eligibility criteria

Qualifiers

Diagnosis of UC from at least 6 months according to clinical, endoscopic, histological and/or radiological criteria.

Male or female age ≥ 18 years

Currently treated by JAK inhibitor (tofacitinib, upadacitinib or filgotinib) for more than 12 months.

Currently at a stable dose of tofacitinib (5mg or 10mg twice a day), upadacitinib (15mg or 30mg per day) or filgotinib (200mg per day) for 6 months.

Disqualifiers

Steroid use ≤ 6 months prior to enrolment.

Currently treated by steroid, immunosuppressive agents or biologics.

Pregnancy or planned pregnancy during the study.

Breastfeeding.

Trial design

Treatments tested in this trial

  • treatment withdrawal

Treatment groups

224 Participants
are divided into 2 treatment groups