A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease

Johnson & Johnson (J&J)

Status: Completed

Conditions: Crohn Disease

Treatments: Drug: Infliximab

Study type: Observational

Funder types: Industry

Identifiers

NCT04312659

C0168CRD4020 (Other Identifier)

CR108748

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 1 patient group

Infliximab

Description:

Participants with pediatric Crohn's disease (CD) who were treated with Infliximab (IFX) and signed the Informed Consent Form (ICF) for the study will be enrolled case by case. Each participants will be followed up for at least 30 weeks. After 30 weeks, participants continuing IFX treatment will be followed up, with a maximum follow-up period of 102 weeks. The primary data source will be participants medical records for all data entered into the CRF.

Treatment:

Drug: Infliximab