Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
- Registration Number
- NCT05906576
- Lead Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- Brief Summary
Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- The investigator judges the subject inappropriate to be included in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Infliximab Infliximab Infliximab for the treatment of Crohn's disease in children
- Primary Outcome Measures
Name Time Method Clinical response rate at 14 weeks up to 14 weeks Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points
- Secondary Outcome Measures
Name Time Method 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 up to 54 weeks 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.
Endoscopic response rate at week 14 and 54 up to 54 weeks Endoscopic response: SES-CD decreased ≥ 50%
Changes from baseline in serum C-reactive protein at week 14 and 54 up to 54 weeks Changes from baseline in serum C-reactive protein at week 14 and 54
Changes from baseline in erythrocyte sedimentation rate at week 14 and 54 up to 54 weeks Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
ADA positive rate up to 54 weeks ADA positive rate at week 14 and 54
Percentage of participants with Adverse Events up to 102 weeks Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study
Mucosal healing rate at week 14 and 54 up to 54 weeks Mucosal healing: SES-CD 0-2
Clinical remission rate at week 14 and 54 up to 54 weeks Clinical remission: PCDAI≤10
Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks up to 54 weeks Delayed development: Female children over 13 years old and male children over 14 years old are in the Tanner stage I
Trial Locations
- Locations (1)
Beijing Children's Hospital, Capital Medical University
🇨🇳Beijing, China