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

Sponsor
University Medical Center Groningen
Study ID
NCT04646187
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Infliximab — BIOLOGICAL
    Dosing interval lengthening from 8 to 12 weeks
  • Adalimumab — BIOLOGICAL
    Dosing interval lengthening from 2 to 3 weeks

Study Details

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.

Key Dates

Start date
Mar 11, 2021
Status verified
Jan 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group
    In patients treated with adalimumab, the dosing interval will be lengthened from 2 to 3 weeks. In patients treated with infliximab, the dosing interval will be lengthened from 8 to 12 weeks. Consists of two groups: Patients randomised to the intervention group and patients allocated to the intervention group based on preference.
  • No Intervention: Control group
    Unchanged dosing interval. Consists of two groups: Patients randomised to the control group and patients allocated to the control group based on preference.

Primary Outcome Measure

cumulative incidence of out-of-range fecal calprotectin results at 48 weeks follow-up [ Time Frame: 48 weeks ]

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