Clinical trial · Interventional
De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease
De-escalation of Anti-TNF Therapy in Adolescents and Young Adults With IBD With Tight Faecal Calprotectin and Trough Level Monitoring
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colitis, Ulcerative | — | UNRESOLVED | — |
| Crohn Disease | — | UNRESOLVED | — |
| Inflammatory Bowel Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adalimumab | Biological | — | UNRESOLVED |
| Infliximab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- 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.
- interventionNames
- Biological: Infliximab
- Biological: Adalimumab
- type
- NO_INTERVENTION
- label
- Control group
- description
- Unchanged dosing interval. Consists of two groups: Patients randomised to the control group and patients allocated to the control group based on preference.
Primary outcomes (1)
- measure
- cumulative incidence of out-of-range fecal calprotectin results at 48 weeks follow-up
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 12-25 years * Diagnosed with luminal Crohn's disease or ulcerative colitis * Treated with either 8-weekly infliximab or 2-weekly adalimumab * Current anti-TNF agent as first ever anti-TNF agent or prior anti-TNF agent discontinued for reason other than primary non-response or secondary loss-of-response * No previous attempts to lengthen the dosing interval * Three consecutive faecal calprotectin (FC) results in the target range (i.e. \<250 μg/g for CD patients; \<150 μg/g for UC patients) in the previous 6 months or confirmed endoscopic remission within 2 months before study entry (i.e. simple endoscopic score for Crohn's disease (SES-CD) \<3 points for CD patients; ulcerative colitis endoscopic index of severity (UCEIS) ≤1 point for UC patients) * Absence of symptoms associated with active IBD (judged by the local IBD-team) * Written informed consent granted Exclusion Criteria: * Perianal fistula * Presence of ileostomy or ileoanal pouch (as FC cut-off is not validated for small bowel faeces) * Any inflammatory comorbidity, such as rheumatoid arthritis * Current treatment with corticosteroids (prednisone or budesonide) * Current pregnancy
References
Publications (2)
- DERIVEDBouhuys M, Wessels MMS, de Vries W, Lambeck AJA, Touw DJ, van Rheenen PF. Lateral flow test versus enzyme-linked immunosorbent assay to measure infliximab trough concentrations: A head-to-head comparison. J Pediatr Gastroenterol Nutr. 2024 Dec;79(6):1134-1141. doi: 10.1002/jpn3.12372. Epub 2024 Oct 10. PMID 39390697
- DERIVEDBouhuys M, Lexmond WS, Dijkstra G, Lobaton T, Louis E, van Biervliet S, Groen H, Guardiola J, Rheenen PV. Efficacy of anti-TNF dosing interval lengthening in adolescents and young adults with inflammatory bowel disease in sustained remission (FREE-study): protocol for a partially randomised patient preference trial. BMJ Open. 2021 Nov 3;11(11):e054154. doi: 10.1136/bmjopen-2021-054154. PMID 34732500