Diagnostic tool to safely CEASE anti-TNF therapy in Crohn’s disease: a center-specific, stepped wedge Randomized Controlled Trial

Amsterdam UMC, location AMC and Erasmus MC0 个研究点目标入组 190 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•1.Anti-TNF therapy =12 months
•2.For low risk: Relapse risk < 33.3% after cessation of anti-TNF as predicted by the CEASE tool (‘low risk’, see Appendix 2).
•3.Age = 16 years.
•4.Ability and willingness to give informed consent.
•5.Luminal CD as indication for anti-TNF therapy.
•6.Duration of anti-TNF treatment = 12 months and a stable dose = 3 months.
•7.Concomitant therapy with an immunosuppressant is allowed (stable dose = 3 months) and will be continued after withdrawal of anti-TNF medication during the study period.

•1.Ulcerative colitis or IBD-unclassified
•2.Co-morbidities that are a contraindication for (dis)continuing anti-TNF therapy
•3.Corticosteroid use for luminal CD 6 months prior to inclusion
•4.Ongoing pregnancy or planned pregnancy for the duration of the study
•5.In the opinion of the investigator, the participant is incapable of understanding and complying with protocol requirements.

发起方

Amsterdam UMC, location AMC and Erasmus MC