Combined Immunosuppression for Pediatric Crohn's Disease

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05043870

Enrollment

128

Registered

2021-09-14

Start date

2022-10-10

Completion date

2026-12-31

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Only, Crohn Disease, Immunosuppression, Infliximab

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.

Interventions

DRUGInfliximab 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

DRUGInfliximab

the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
clinical remission	week 54	The clinical remission rate at week 54
endoscopic remission	week 54	The endoscopic remission rate at week 54

Secondary

Measure	Time frame	Description
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.

Countries

China

Contacts

CONTACTLin Wang

wanglin546974055@163.com+8613817510412

STUDY_DIRECTORYing Huang

Children's Hospital of Fudan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026