Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
Age ranged 6 to 17 years (both inclusive), no gender limitation.
A clear diagnosis was made in children with moderate to severe active stage (PCDAI≥30) Crohn's disease refer to the expert consensus on the diagnosis and treatment of inflammatory bowel disease in children (2019 edition).
Patients and/or their guardians must sign ICF, and the research agreement/ICF for data collection and data verification shall comply with local laws and regulations.
The patient received infliximab for the first time.
Patients with contraindications to infliximab use (such as severe infection, active tuberculosis, lymphoma or other malignancies), moderate to severe heart failure, and allergies to other murine proteins, infliximab or any component of this product.
Those who accept other anti-TNF-α any biological drugs or any other biologicals.
Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period
Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF
Single group
Infliximab
DrugInfliximab in the treatment of Crohn's disease in children
Clinical response rate at 14 weeks
Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points
Clinical remission rate at week 14 and 54
Clinical remission: PCDAI≤10
Endoscopic response rate at week 14 and 54
Endoscopic response: SES-CD decreased ≥ 50%
Mucosal healing rate at week 14 and 54
Mucosal healing: SES-CD 0-2
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.
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