NCT05043870

Combined Immunosuppression for Pediatric Crohn's Disease

Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Crohn Disease
• Infliximab
• Immunosuppression
• Children, Only

Interventions

Type	Name	Description
DRUG	Infliximab and immunosuppressives	the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks, the immunomodulatory agent was azathioprine 1-2mg/kg per day or methotrexate 10-25 mg/m2 week
DRUG	Infliximab	the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks

Timeline

• Start date: 2022-10-10
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2021-09-14
• Last updated: 2026-03-19

Locations

1 site across 1 country: China