Combined Immunosuppression for Pediatric Crohn's Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Immunosuppression; Children, Only; Infliximab
• Intervention / Treatment: Drug: Infliximab and immunosuppressives; Drug: Infliximab

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lin Wang; Phone Number: +8613817510412; Email: wanglin546974055@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201102
      • Recruiting
      • Children's Hospital of Fudan University
      • Contact: Lin Wang, Doctor; Phone Number: 13817510412; Email: wanglin546974055@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: infliximab and immunosuppressives therapy; 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	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; Other Names: IFX, IMMs, AZA, MTX
Active Comparator: infliximab therapy; the infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks	Drug: Infliximab; the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks; Other Names: IFX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical remission	The clinical remission rate at week 54	week 54
endoscopic remission	The endoscopic remission rate at week 54	week 54

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Crohn's disease Activity Index score	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.	week0, week2, week6, week14, week22, week30, week38, week46, week54

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
infliximab concentration	The infliximab (IFX) concentration and anti-infliximab antibodies (ATI) were measured before the infusion of week 14, 38.	week 14, 38
adverse events	The rate of the potential adverse events were monitored during the intervention.	within one year

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Director: Ying Huang, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: September 5, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Immunologic Factors; Physiological Effects of Drugs; Amino Acids, Peptides, and Proteins; Proteins; Pharmacologic Actions; Chemical Actions and Uses; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Infliximab; Immunosuppressive Agents
• Other Study ID Numbers: Combined therapy in CD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No