Trials / Completed
CompletedNCT02141984
Surveillance of Humira in Korean JIA Patients
Post-Marketing Surveillance of Humira Injection in Korean JIA Patients Under the New-Drug Re-examination
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 28 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2016-04-01
- Completion
- 2016-04-01
- First posted
- 2014-05-20
- Last updated
- 2017-06-23
- Results posted
- 2017-06-23
Source: ClinicalTrials.gov record NCT02141984. Inclusion in this directory is not an endorsement.