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

Mabpharm

Status and phase: Enrolling; Phase 4

Conditions: Crohn Disease

Treatments: Drug: Infliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05906576

C008CDIV

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Infliximab

Experimental group

Description:

Infliximab for the treatment of Crohn's disease in children

Treatment:

Drug: Infliximab