De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease (FREE)
Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring Infliximab, Adalimumab, Tumor Necrosis Factor-alpha, Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
Eligibility Criteria
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
Sites / Locations
- Universitair Ziekenhuis Gent
- Centre hospitalier universitaire de Liège
- Rijnstate Hospital
- Catharina Hospital Eindhoven
- University Medical Center GroningenRecruiting
- Zuyderland Medical Center
- Hospital Universitari de Bellvitge
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention group
Control 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.
Unchanged dosing interval. Consists of two groups: Patients randomised to the control group and patients allocated to the control group based on preference.