Combined Immunosuppression for Pediatric Crohn's Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-18
SponsorChildren's Hospital of Fudan University
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
history of biological agents targeting at tumor necrosis factor (TNF)
Crohn's Disease-related surgery
infections
tumors
Trial design
Treatments tested in this trial
- Infliximab and immunosuppressives
- Infliximab
Treatment groups
128 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov