Testing Less Frequent Anti-TNF Doses in Young People With Inflammatory Bowel Disease
Tests spacing out infliximab or adalimumab doses in young people with Crohn disease or colitis.
Plain-language title generated from the registry record
Registry title: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease
Key facts
- Where
- L'hospitalet De Llobregat, SpainSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for young people aged 12 to 25 with Crohn's disease or ulcerative colitis who are in remission on an anti-TNF drug (infliximab or adalimumab). It tests whether the time between doses can be made longer.
- Age
- 12 to 25 years
- Sex
- All sexes can join.
- Disease stage
- Luminal Crohn's disease or ulcerative colitis, in remission: no symptoms of active IBD, and faecal calprotectin results in the target range or remission confirmed by endoscopy.
- Earlier treatment
- Treated with infliximab every 8 weeks or adalimumab every 2 weeks. It must be the first anti-TNF drug, or an earlier one was stopped for a reason other than no response or loss of response. No earlier attempt to lengthen the dosing interval.
- Biomarker or test result
- Three faecal calprotectin results in a row in the target range in the last 6 months: under 250 μg/g for Crohn's disease, under 150 μg/g for ulcerative colitis. Or remission confirmed by endoscopy in the last 2 months.
Main reasons for not taking part
- Perianal fistula
- Ileostomy or ileoanal pouch
- Another inflammatory illness, such as rheumatoid arthritis
- Current treatment with corticosteroids (prednisone or budesonide)
- Current pregnancy
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 25 years old?
Source: NCT04646187, who can take part
Where in Spain
- Bellvitge University HospitalL'hospitalet De Llobregat, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Medical Center Groningen
- Trial code
- NCT04646187EU 2024-516277-68-00
- Record updated
- 6 January 2025
- Original description
BACKGROUND/RATIONALE:Read full original descriptionShow less
De-escalation of Anti-TNF Therapy in Adolescents and Young Adults With IBD With Tight Faecal Calprotectin and Trough Level Monitoring
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.
Inclusion: 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: Current treatment with corticosteroids (prednisone or budesonide); 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 pregnancy.