De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease

BACKGROUND/RATIONALE: Treatment outcomes of patients with inflammatory bowel disease (IBD) have improved enormously during the past decade due to the use of anti-tumour necrosis factor (anti-TNF) therapy. As a result, 67 to 91% of paediatric patients and 66% of adult patients is still in sustained remission two years after the initiation of anti-TNF therapy. Prolonged use of anti-TNFs comes with disadvantages such as dose dependent susceptibility to infections and dermatological adverse effects. Preliminary, mostly uncontrolled studies suggest that dose reduction by dosing interval lengthening is a realistic option in a relevant proportion of patients with IBD, provided that intensive follow-up is applied. OBJECTIVE: To evaluate whether a faecal calprotectin (FC) guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD, compared with an unchanged dosing interval.

NCT Number	NCT04646187
Lead Sponsor	University Medical Center Groningen Collaborators: European Crohn´s and Colitis Organisation, Bühlmann Laboratories AG
Conditions	Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
Enrollment	148 participants
Start Date	2021-03-11
Primary Completion	2026-03 (estimated)
Study Completion	2026-03 (estimated)
Updated on ClinicalTrials.gov	2025-01-06