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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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 Summary of Product Characteristics (SmPC) 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.

Detailed Summary:
Sponsor: AbbVie

Current Primary Outcome: Number of subjects with adverse events [ Time Frame: From Day 0 (informed consent) to up to 70 days following the last administration of Humira® ]

Adverse event information is collected to assess prevalence of safety.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: AbbVie

Dates:
Date Received: October 15, 2015
Date Started: September 2015
Date Completion: May 2017
Last Updated: February 2, 2017
Last Verified: February 2017