Combined Immunosuppression for Pediatric Crohn's Disease
Recruiting · NCT05043870 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Hospital of Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
InfliximabInfliximab and immunosuppressives
What this trial is about
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.
Who can take part
Age range
6 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- history of biological agents targeting at tumor necrosis factor (TNF)
- Crohn's Disease-related surgery
- infections
- tumors
Where it is running
1 location listed.
- Children's Hospital of Fudan University - Shanghai, Shanghai Municipality, China