CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 143 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02578238
NCT02578238N/ACompleted

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

AbbVie·observational·Posted Oct 16, 2015·Updated Dec 19, 2018

In Brief

An observational study for Pediatric Crohn's Disease. Completed, enrolled 143 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 16, 2015
Enrollment StartSep 24, 2015
Primary CompletionMay 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.7 years ago