Combined Immunosuppression for Pediatric Crohn's Disease
Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease
1 other identifier
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2022
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2021
CompletedFirst Posted
Study publicly available on registry
September 14, 2021
CompletedStudy Start
First participant enrolled
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 19, 2026
March 1, 2026
4.1 years
September 2, 2021
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
clinical remission
The clinical remission rate at week 54
week 54
endoscopic remission
The endoscopic remission rate at week 54
week 54
Secondary Outcomes (1)
Pediatric Crohn's disease Activity Index score
week0, week2, week6, week14, week22, week30, week38, week46, week54
Other Outcomes (2)
infliximab concentration
week 14, 38
adverse events
within one year
Study Arms (2)
infliximab and immunosuppressives therapy
EXPERIMENTALthe 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
ACTIVE COMPARATORthe infusion of infliximab (IFX) (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks
Interventions
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
the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- history of biological agents targeting at tumor necrosis factor (TNF)
- Crohn's Disease-related surgery
- infections
- tumors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ying Huang
Children's Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of department of gastroenterology
Study Record Dates
First Submitted
September 2, 2021
First Posted
September 14, 2021
Study Start
October 10, 2022
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 19, 2026
Record last verified: 2026-03