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

NCT04646187 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-01-06

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases
  • Crohn Disease
  • Colitis, Ulcerative

Interventions

BIOLOGICAL

Infliximab

Dosing interval lengthening from 8 to 12 weeks

BIOLOGICAL

Adalimumab

Dosing interval lengthening from 2 to 3 weeks

Sponsors & Collaborators

  • European Crohn´s and Colitis Organisation

    collaborator UNKNOWN

  • Bühlmann Laboratories AG

    collaborator INDUSTRY

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Patrick F van Rheenen, MD PhD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-11
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Belgium
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04646187 on ClinicalTrials.gov