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

C008CDIV

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

2023-09-21

2026-11-01

2027-02-01

Recruiting

Early phase I

30

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2024-04-11