NCT01083121

Surveillance of Humira Injection in Korean Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,779 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and observed in normal medical practice setting for not less than 3 months following first dose of Humira. Information on demographics, diagnosis and medical history, results of tuberculosis skin test, results of chest X-ray, Humira treatment information, concomitant medication, physician's global assessment for effectiveness, disease activity assessment for rheumatoid arthritis, disease activity assessment for Crohn's Disease, disease activity assessment for Psoriasis and adverse events will be recorded on case report forms.

Conditions

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Ankylosing Spondylitis
• Crohn's Disease
• Psoriasis

Timeline

• Start date: 2007-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-03-09
• Last updated: 2013-08-21
• Results posted: 2013-08-20

Locations

77 sites across 1 country: South Korea