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

Recruiting

• Conditions: Crohn's Disease; Inflammatory Bowel Disease; 10017969

• Registration Number: NL-OMON54559
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 252

Inclusion Criteria

- Luminal CD as indication for anti-TNF therapy
- Clinical remission (HBI < 5)
- Duration of anti-TNF treatment >= 12 months and a stable dose >= 3 months
- Relapse risk < 33.3% after cessation of anti-TNF as predicted by the
diagnostic tool (*low risk*)

Exclusion Criteria

- Ulcerative colitis or IBD-unclassified.
- Co-morbidities that are a contraindication for (dis)continuing anti-TNF
therapy (such as rheumatic diseases or perianal fistula)
- Corticosteroid use 6 months prior to inclusion
- Malignancy (< 5 years prior to start of the study)
- Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is a documented relapse of CD or CD complications that<br /><br>necessitates (re)introduction of biologicals, corticosteroids,<br /><br>immunosuppressants, antibiotics, or surgery for Crohn*s Disease complications.<br /><br>A documented relapse of CD is defined as a clinical relapse (HBI >= 5) in<br /><br>combination with faecal calprotectin > 250 µg/g and/or endoscopic ulcerations. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Maintenance of remission; time to relapse; sustained low-risk for relapse;<br /><br>quality of Life: IBD-Q and EQ-5D; work productivity; total costs: drug costs,<br /><br>other health care costs (iMCQ) and productivity loss (iPCQ); costeffectiveness<br /><br>analysis after 1 and 2 years.</p><br>