RecruitingPhase 4

Combined Immunosuppression for Pediatric Crohn's Disease

China128 participantsStarted 2022-10-10

Plain-language 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.

Who can participate

Age range6 Years – 18 Years

SexALL

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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

What they're measuring

clinical remission

Timeframe: week 54

endoscopic remission

Timeframe: week 54

Trial details

NCT IDNCT05043870

SponsorChildren's Hospital of Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-31

Contact for this trial

Lin Wang

+8613817510412 wanglin546974055@163.com

View on ClinicalTrials.gov More Crohn Disease trials