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
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.
Steroid use ≤ 6 months prior to enrolment.
Currently treated by steroid, immunosuppressive agents or biologics.
Pregnancy or planned pregnancy during the study.
Breastfeeding.
Parallel
treatment withdrawal
Drugthe patients will stop their treatment, as long as possible until symptom reappearance, if any
The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up.
treatment safety, during the first 52 weeks of the follow-up.
The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up.
treatment efficacy, during the first 52 weeks of the follow-up.
The primary endpoint of this study will be a composite criterion of treatment safety, efficacy, and patient satisfaction during the first 52 weeks of the follow-up.
patient satisfaction during the first 52 weeks of the follow-up.
Safety: occurrence of herpes zoster, infection, cardiovascular event, biochemical parameter, malignancies, adverse event leading to discontinuation, and all adverse events (serious or not) during the whole follow-up.
Remission rate at the end the first 52 weeks of the follow-up
Assess the treatment success of this innovative therapeutic strategy at the end of the first 52 weeks of the follow-up and after 104 weeks of follow-up.
Partial Mayo score at each visit of the entire follow-up
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This trial is not recruiting at the moment. You can still explore other options:
