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
- Gent and Liège, BelgiumSee the 3 sites
- Phase
- Phase 4
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 Belgium
- Universitair Ziekenhuis GentGent, BelgiumTaking people
- Centre Hospitalier Regional de la CitadelleLiège, BelgiumTaking people
- Centre Hospitalier Universitaire de LiègeLiège, BelgiumTaking 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?
Trial 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.