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

Study acronym: FREE
StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 6, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Mar 2025 to Mar 2026 Study sites: 8 to 7v7 Show 1 more changeShow less
    • Study sites: 8 to 7
  2. Primary and study completion dates: Jun 2023 to Mar 2025 Trial status: Recruiting to Enrolling by Invitation · Study sites: 7 to 8v6 Show 2 more changesShow less
    • Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 7 to 8
  3. Primary and study completion dates: Apr 2022 to Jun 2023 Study sites: 4 to 7 · Eligibility criteria expanded, about 2 wordsv5 Show 2 more changesShow less
    • Study sites: 4 to 7
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv4
  5. Start date: Jan 18, 2021 to Mar 11, 2021 Eligibility criteria expanded, about 17 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 2020 to Jan 18, 2021 · Site details revised at 4 of 4 sitesv2 Show 2 more changesShow less
    • Start date: Dec 2020 to Jan 18, 2021
    • Site details revised at 4 of 4 sites
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov