Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
This is a prospective, multicenter registry study in Chinese pediatric Crohn's disease patients. A total of 30 subjects were planned to be enrolled and treated with Infliximab. Subjects were observed for 102 weeks after administration to evaluate the clinical efficacy and safety of infliximab in the treatment of children with Crohn's disease in a real diagnostic setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Infliximab in the treatment of Crohn's disease in children
Beijing Children's Hospital, Capital Medical University
Beijing, China
RECRUITINGClinical response rate at 14 weeks
Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points
Time frame: up to 14 weeks
Clinical remission rate at week 14 and 54
Clinical remission: PCDAI≤10
Time frame: up to 54 weeks
Endoscopic response rate at week 14 and 54
Endoscopic response: SES-CD decreased ≥ 50%
Time frame: up to 54 weeks
Mucosal healing rate at week 14 and 54
Mucosal healing: SES-CD 0-2
Time frame: up to 54 weeks
Changes from baseline in height-for-age z-score (HAZ), weight-for-age z-score (WAZ) and BMI-for-age z-score at week 14 and 54
The z-score is converted from anthropometric measurements based on the World Health Organization growth reference. The z-score including: height-for-age z-score (HAZ), weight-for-age z-score (WAZ) and BMI-for-age z-score.
Time frame: up to 54 weeks
Changes from baseline in serum C-reactive protein at week 14 and 54
Changes from baseline in serum C-reactive protein at week 14 and 54
Time frame: up to 54 weeks
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
Time frame: up to 54 weeks
Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks
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Delayed development: Female children over 13 years old and male children over 14 years old are in the Tanner stage I
Time frame: up to 54 weeks
ADA positive rate
ADA positive rate at week 14 and 54
Time frame: up to 54 weeks
Percentage of participants with Adverse Events
Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study
Time frame: up to 102 weeks