De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring

Phase 4

Recruiting

Conditions: Crohn's disease
ulcerative colitis
10017969
10003816

Registration Number: NL-OMON52654

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

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
NL73966.042.20 / FREE-study (v3.6)
17 of 47
confirmed endoscopic remission within 2 months before study entry (i.e. simple
endoscopic score for Crohn*s disease (SES-CD) <3 points; ulcerative colitis
endoscopic index of severity (UCEIS) <=1 point or Mayo endoscopic subscore <=1
point)
- 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
- Any inflammatory comorbidity, such as rheumatoid arthritis
- Current treatment with corticosteroids (prednisone or budesonide)
- Current pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The cumulative incidence of out-of-range FC results at 48 weeks follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(1) time to get out-of-range FC results<br /><br>(2) cumulative incidence of anti-TNF-associated respiratory infections and<br /><br>dermatological adverse effects at 48 weeks follow-up<br /><br>(3) evolution of FC and anti-TNF trough levels in the first 16 weeks after<br /><br>reverting to previous dosing interval<br /><br>(4) proportion of patients developing loss-of-response in the first 16 weeks<br /><br>after reverting to the previous dosing interval<br /><br>(5) identification of predictors of successful de-escalation.</p><br>