Combined Immunosuppression for Pediatric Crohn's Disease
Recruiting
Phase 4
Interventional Study
Crohn Disease
Infliximab
Immunosuppression
Children, Only
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 – 18
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 128 (estimated)
- Sponsor
- Children's Hospital of Fudan University · Other
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About This Trial
This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 6-18 years old
2. diagnosis of Crohn's Disease
3. Pediatric Crohn's disease Activity Index (PCDAI)\>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) \>10 before treatment
4. receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatri…
Contacts