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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
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
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGclinical 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.