A Phase 4 interventional study of Infliximab and immunosuppressives and Infliximab in Crohn Disease, Infliximab and Immunosuppression, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Children's Hospital of Fudan University · Phase 4, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 128 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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, the immunomodulatory agent was azathioprine 1-2mg/kg per day or methotrexate 10-25 mg/m2 week
Also known as: IFX, IMMs, AZA, MTX
the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks
Also known as: IFX
clinical remission
The clinical remission rate at week 54
Time frame: week 54
endoscopic remission
The endoscopic remission rate at week 54
Time frame: week 54
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.
Time frame: week0, week2, week6, week14, week22, week30, week38, week46, week54
infliximab concentration
The infliximab (IFX) concentration and anti-infliximab antibodies (ATI) were measured before the infusion of week 14, 38.
Time frame: week 14, 38
adverse events
The rate of the potential adverse events were monitored during the intervention.
Time frame: within one year
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Children's Hospital of Fudan University