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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 January 2025
• Main ID: NCT04646187
• Date of registration: 20/11/2020
• Prospective Registration: Yes
• Primary sponsor: University Medical Center Groningen
• Public title: De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease FREE
• Scientific title: De-escalation of Anti-TNF Therapy in Adolescents and Young Adults With IBD With Tight Faecal Calprotectin and Trough Level Monitoring
• Date of first enrolment: March 11, 2021
• Target sample size: 148
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/ct2/show/NCT04646187
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Belgium, Netherlands, Spain

Contacts

• Name: Patrick F van Rheenen, MD PhD
• Affiliation: University Medical Center Groningen

Key inclusion & exclusion 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


Age minimum: 12 Years
Age maximum: 25 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Colitis, Ulcerative

Inflammatory Bowel Diseases

Intervention(s)

Biological: Adalimumab

Biological: Infliximab

Primary Outcome(s)

cumulative incidence of out-of-range fecal calprotectin results at 48 weeks follow-up [Time Frame: 48 weeks]

Secondary Outcome(s)

Evolution of FC and anti-TNF trough levels in the first 16 weeks after reverting to previous dosing interval [Time Frame: Up to 48+16 weeks]

Time to get out-of-range fecal calprotectin results [Time Frame: up to 48 weeks]

Proportion of patients developing loss-of-response in the first 16 weeks after reverting to the previous dosing interval [Time Frame: Up to 48+16 weeks]

Cumulative incidence of anti-TNF-associated respiratory infections and dermatological adverse effects at 48 weeks follow-up [Time Frame: 48 weeks]

Identification of predictors of successful de-escalation. [Time Frame: 48 weeks]

Secondary ID(s)

202000261

2020-001811-26

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European Crohn´s and Colitis Organisation

Bühlmann Laboratories AG