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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 1 March 2021
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: Recruiting
URL:  https://clinicaltrials.gov/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
Address: 
Telephone: 050 3614151
Email: p.f.van.rheenen@umcg.nl
Affiliation: 
Name:     Patrick F van Rheenen, MD PhD
Address: 
Telephone:
Email:
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)



Age minimum: 12 Years
Age maximum: 25 Years
Gender: All
Health Condition(s) or Problem(s) studied
Colitis, Ulcerative
Crohn Disease
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)
Cumulative incidence of anti-TNF-associated respiratory infections and dermatological adverse effects at 48 weeks follow-up [Time Frame: 48 weeks]
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]
Identification of predictors of successful de-escalation. [Time Frame: 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]
Time to get out-of-range fecal calprotectin results [Time Frame: up to 48 weeks]
Secondary ID(s)
2020-001811-26
202000261
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bühlmann Laboratories AG
European Crohn´s and Colitis Organisation
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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