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NCT Number: NCT05043870

Combined Immunosuppression 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.

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Key information

Conditions

Crohn Disease Children, Only Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immunosuppression Inflammatory Bowel Diseases Infliximab Intestinal Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location status: Recruiting

Location contact

Lin Wang, Doctor

CONTACT

[email protected]

13817510412

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 6-18 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

Exclusion criteria

  • history of biological agents targeting at tumor necrosis factor (TNF)
  • Crohn's Disease-related surgery
  • infections
  • tumors

Treatment and study plan

Infliximab and immunosuppressives

Drug

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

Infliximab

Drug

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

Other names: IFX

Primary outcomes

  1. clinical remission

    Time frame: week 54

    The clinical remission rate at week 54

  2. endoscopic remission

    Time frame: week 54

    The endoscopic remission rate at week 54

Secondary outcomes

  1. Pediatric Crohn's disease Activity Index score

    Time frame: 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.

Other outcomes

  1. infliximab concentration

    Time frame: week 14, 38

    The infliximab (IFX) concentration and anti-infliximab antibodies (ATI) were measured before the infusion of week 14, 38.

  2. adverse events

    Time frame: within one year

    The rate of the potential adverse events were monitored during the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Wang

CONTACT

[email protected]

+8613817510412

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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