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De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease
Sponsor: University Medical Center Groningen
Summary
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.
Official title: De-escalation of Anti-TNF Therapy in Adolescents and Young Adults With IBD With Tight Faecal Calprotectin and Trough Level Monitoring
Key Details
Gender
All
Age Range
12 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
148
Start Date
2021-03-11
Completion Date
2026-03
Last Updated
2025-01-06
Healthy Volunteers
No
Interventions
Infliximab
Dosing interval lengthening from 8 to 12 weeks
Adalimumab
Dosing interval lengthening from 2 to 3 weeks
Locations (7)
Universitair Ziekenhuis Gent
Ghent, Belgium
Centre hospitalier universitaire de Liège
Liège, Belgium
Centre hospitalier régional de la Citadelle
Liège, Belgium
Rijnstate Hospital
Arnhem, Netherlands
Catharina Hospital Eindhoven
Eindhoven, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain