A Multi-Center Registry Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease

CR108748

The main purpose of this study is to record the use of Infliximab (IFX) in the treatment of Chinese children with Crohn's disease (CD) in routine clinical practice and to summarize the clinical efficacy and safety of IFX in the treatment of pediatric CD.

2020-07-15

2023-09-12

2023-09-12

Completed

38

Inclusion Criteria: * Must have a confirmed diagnosis of Crohn's disease * Must sign, and their legal guardians/legally-acceptable representative where applicable must sign, a participation agreement/ICF allowing data collection and source data verification in accordance with local requirements * First-time received IFX treatment Exclusion Criteria: * History of medical contraindications for Infliximab (IFX), example. serious infections, active tuberculosis (TB), lymphoma and other malignancies, moderate to severe heart failure, hypersensitivity to inactive components of the product or to any murine proteins * Previous exposure to Infliximab or any other biologics * Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the start of the study or the first data collection time point * Currently enrolled in an investigational study * Have other Crohn's-like disease that are associated with mono-genetic immune disorders

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 38, 'type': 'ACTUAL'}}

2023-10-12