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ENROLLING BY INVITATION
NCT04646187
PHASE4

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

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

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

BIOLOGICAL

Infliximab

Dosing interval lengthening from 8 to 12 weeks

BIOLOGICAL

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