Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients

Study Overview
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Brief Summary
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Post-marketing registration of Infliximab for injection in Chinese pediatric Crohn's disease patients.

Detailed Description
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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.

Official Title
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Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: Infliximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infliximab<br>Infliximab for the treatment of Crohn's disease in children | Drug: Infliximab<br>* Infliximab in the treatment of Crohn's disease in children<br>* Other names: CMAB008;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate at 14 weeks | Clinical response: PCDAI decreased ≥15 points and total PCDAI≤ 30 points | up to 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission rate at week 14 and 54 | Clinical remission: PCDAI≤10 | up to 54 weeks | 
| Endoscopic response rate at week 14 and 54 | Endoscopic response: SES-CD decreased ≥ 50% | up to 54 weeks | 
| Mucosal healing rate at week 14 and 54 | Mucosal healing: SES-CD 0-2 | 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. | 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 | 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 | up to 54 weeks | 
| Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks | Delayed development: Female children over 13 years old and male children over 14 years old are in the Tanner stage I | up to 54 weeks | 
| ADA positive rate | ADA positive rate at week 14 and 54 | 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 | up to 102 weeks |