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
Inclusion Criteria:
Exclusion Criteria:
amandine.rolland@ap-hm.fr+33 04 91 38 12 45 ext. +33
Amiens, France
fumery.mathurin@chu-amiens.fr+330322088849
benezech.alban@ch-avignon.fr+330432753409
lvuitton@chu-besancon.fr+330381218683
pauline.riviere@chu-bordeaux.fr+330557656094
a_buisson@chu-clermontferrand.fr+330473750598
maria.nachury@chru-lille.fr+330320444714
lucas.guillo@ap-hm.fr+330491968737
r-altwegg@chu-montpellier.fr+330467337064
b.caron@chru-nancy.fr
arnaud.bourreille@chu-nantes.fr+330240083152
nicolau.a@chu-nice.fr+330492036168
Ludovic.CAILLO@chu-nimes.fr+330466683183
alexandre.nuzzo@aphp.fr+330140875668
aurelien.amiot@aphp.fr+330145213726
mathieu.uzzan@aphp.fr+330149812362
carmen.stefanescu@institutdesmici.fr+330141430573
Guillaume.BOUGUEN@chu-rennes.fr+330299284347
nicolas.richard@chu-rouen.fr+330232886634
xavier.roblin@chu-st-etienne.fr+330477828119
camille.sibertin-blanc@ch-toulon.fr+330494144163
Gilletta.c@chu-Toulouse.fr+330561323080
A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis
The Safety And Efficacy Of Maintenance Therapy With CP-690,550
TOFACITINIB vs TOFACITINIB WITH MESALAMINE IN ULCERATIVE COLITIS
Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission