Clinical trial NCT05906576: Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
Official title: Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Crohn Disease
Lead sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age ranged 6 to 17 years (both inclusive), no gender limitation.
2. 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).
3. 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.
4. The patient received infliximab for the first time.

Exclusion Criteria:

1. 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.
2. Those who accept other anti-TNF-α any biological drugs or any other biologicals.
3. Patients who plan to receive live vaccine within 3 months before signing the informed consent or during the treatment period
4. Those who have been or being enrolled in other clinical studies within 3 months prior to signing ICF
5. The investigator judges the subject inappropriate to be included in this study.

Primary outcomes:
measure: Clinical response rate at 14 weeks
timeFrame: up to 14 weeks
Secondary outcomes:
measure: Clinical remission rate at week 14 and 54
timeFrame: up to 54 weeks
measure: Endoscopic response rate at week 14 and 54
timeFrame: up to 54 weeks
measure: Mucosal healing rate at week 14 and 54
timeFrame: up to 54 weeks
measure: 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
timeFrame: up to 54 weeks
measure: Changes from baseline in serum C-reactive protein at week 14 and 54
timeFrame: up to 54 weeks
measure: Changes from baseline in erythrocyte sedimentation rate at week 14 and 54
timeFrame: up to 54 weeks
measure: Changes from baseline in the rate of delayed development of adolescents at 14 and 54 weeks
timeFrame: up to 54 weeks
measure: ADA positive rate
timeFrame: up to 54 weeks
measure: Percentage of participants with Adverse Events
timeFrame: up to 102 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
Study officials:
affiliation: Beijing Children's Hospital
name: Wu Jie
role: PRINCIPAL_INVESTIGATOR
References: