Combined Immunosuppression for Pediatric Crohn's Disease

Phase 4

Recruiting

• Conditions: Immunosuppression; Infliximab; Crohn Disease; Children, Only
• Interventions: Drug: Infliximab and immunosuppressives; Drug: Infliximab

• Registration Number: NCT05043870
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-05
• Study First Posted: 2021-09-14
• Study Start: 2022-10-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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, 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
5. The patient or legal guardian sign the informed consent documents

Exclusion Criteria

1. history of biological agents targeting at tumor necrosis factor (TNF)
2. Crohn's Disease-related surgery
3. infections
4. tumors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
infliximab and immunosuppressives therapy	Infliximab and immunosuppressives	the infusion of infliximab (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
infliximab therapy	Infliximab	the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks

Primary Outcome Measures

Name	Time	Method
endoscopic remission	week 54	The endoscopic remission rate at week 54
clinical remission	week 54	The clinical remission rate at week 54

Secondary Outcome Measures

Name	Time	Method
Pediatric Crohn's disease Activity Index score	week0, week2, week6, week14, week22, week30, week38, week46, week54	The Pediatric Crohn's disease Activity Index (PCDAI) was assessed at each infusion point. PCDAI score ranges from 0 to 100, the higher means the worse outcome.

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China