A Prediction Model to Safely CEASE Anti-TNF Therapy in Patients with Crohn's Disease

Conditions: Crohn's Disease

Registration Number: NL-OMON25895

Lead Sponsor: Amsterdam UMC, location AMC and Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 190

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is a documented relapse of CD or CD complications, which necessitates medical or surgical intervention. <br><br>A relapse of luminal CD is defined as: <br>-Clinical relapse; HBI = 5, on two consecutive measurements, with two weeks between both measurements, AND<br>-Biochemical relapse; FCP = 250 µg/g on two consecutive measurements, with two weeks between both measurements, OR<br>-Endoscopic relapse; ulcerations on endoscopy.<br><br>CD complications include the following:<br>-Active fistula <br>-Perianal abscess <br>-Extra-intestinal manifestations, including but not limited to pyoderma gangrenosum, erythema nodosum.

Secondary Outcome Measures

Name	Time	Method
-Maintenance of remission, defined as a HBI < 5, FCP < 250 µg/g until the end of the follow-up period.<br>-Signs of inflammation on endoscopy.<br>-Time to relapse<br>-Sustained low-risk for relapse according to the CEASE tool<br>-Quality of Life: IBD-Q and EQ-5D-5L<br>-Patient reported outcome: PRO2<br>-Total costs: drug costs, other health care costs (iMCQ), work productivity and produc-tivity loss (iPCQ).<br>