Post-Marketing Surveillance of Humira in Korean Pediatric Crohn's Disease (CD) Patients Under the "New-Drug Re-examination"

AbbVie

Status: Completed

Conditions: Pediatric Crohn's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02578238

P15-619

Details and patient eligibility

About

This study is a non-interventional, observational study of Humira® in the treatment of pediatric CD as per the New Drug Re-examination Guideline in Korea. This study will be conducted in institutions which provide a written agreement to AbbVie Korea, and where the use of Humira® for pediatric CD is following their normal medical practice setting. Pediatric patients who are prescribed Humira® as per physician's medical judgment in accordance with the approved Korean local label will be enrolled in the study. As this is a post marketing surveillance, AbbVie is NOT involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.

Enrollment: 143 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients with CD who are prescribed Humira in accordance with the Korean label for Humira authorization (labeling)
• Patients who have given written authorization to use their personal health data for the purposes of this study.

Exclusion criteria

• Any contraindications to Humira as listed on the approved product market authorization (labeling)
• Patients who is participating on other clinical trials.

Trial design

143 participants in 1 patient group

Participants With Pediatric CD

Description:

Participants with pediatric CD who have been prescribed Humira® (adalimumab) by the treating physician.