Compares infliximab alone or with immunosuppressive drugs in children with Crohn's disease
Tests infliximab alone or combined with immunosuppressives in children with Crohn's disease.
Plain-language title generated from the registry record
Registry title: Combined Immunosuppression for Pediatric Crohn's Disease
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 18 years old?
Source: NCT05043870, who can take part
Where in China
- Children's Hospital Of Fudan UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Children's Hospital of Fudan University
- Trial code
- NCT05043870
- Record updated
- 19 March 2026
- Original description
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.Read full original descriptionShow less
Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease
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.
Inclusion: 6-18 years old; diagnosis of Crohn's Disease; Pediatric Crohn's disease Activity Index (PCDAI)>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) >10 before treatment; receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatric Crohn's disease Activity Index (PCDAI)>10 or The Simple Endoscopic Score for Crohn Disease (SES-CD)≥3 after exclusive enteral nutrition or corticosteroids; The patient or legal guardian sign the informed consent documents.
Exclusion: history of biological agents targeting at tumor necrosis factor (TNF); Crohn's Disease-related surgery; infections; tumors.