NCT04646187RecruitingPhase 4
FREE-study
FREE-study; De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate whether an 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 148 (estimated)
- First submitted
- 29 Aug 2024
- Start date
- 19 Sept 2024
- Lead sponsor
- Universitair Medisch Centrum Groningen
- EU CT number
- 2024-516277-68-00
- EudraCT number
- 2020-001811-26
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 148
- 7 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with corticosteroids (prednisone or budesonide)
Other illness
- Perianal fistula
Other
- 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
Who the study is looking for
- 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
Age in the registry: 12 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Centre Hospitalier Regional de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Recruiting |
| Rijnstate Ziekenhuis Stichting Coordinator of this site? Confirm its status | Arnhem | Netherlands | Recruiting |
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.