NCT02578238

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

Post-Marketing Surveillance of Humira in Korean Pediatric CD Patients Under the "New-Drug Re-examination"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 143 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pediatric Crohn's Disease

Timeline

• Start date: 2015-09-24
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2015-10-16
• Last updated: 2018-12-19
• Results posted: 2018-12-19