CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 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/NCT02141984
NCT02141984N/ACompleted

Post-Marketing Surveillance of Humira Injection in Korean JIA Patients Under the New-Drug Re-examination

AbbVie·observational·Posted May 20, 2014·Updated Jun 23, 2017

In Brief

An observational study for Polyarticular Juvenile Idiopathic Arthritis. Completed, enrolled 28 participants.

Detailed Summary

Approximately 600 pediatric patients prescribed Humira Injection in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, underlying diseases and complications especially in regard to purified protein derivative (PPD) skin test, and chest X-ray. At routine visits for Humira Injection administration, which will occur according to usual medical practice, concomitant medication information and adverse events information will be collected for up to 70 days after the last administration of Humira.

Study Details

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

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 20, 2014
Enrollment StartMay 1, 2014
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.1 years ago