Korean Post-marketing Surveillance for Orencia®

Korean Post-marketing Surveillance for Orencia®

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Orencia® so that the regulatory authority can manage the marketing approval properly.

Time Perspective: Prospective / Retrospective(On-treatment)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Patients must be diagnosed with: Adult Rheumatoid arthritis (RA): adult patients with moderate-to-severe active RA

Or

• Juvenile idiopathic RA: juvenile patients aged 6 years and older with moderate-to-severe active RA

Exclusion Criteria:

• Children aged <6 years
• Pregnant or lactating women
• Patients who are participating in another study
• Patients known to be hypersensitive to the active component of the surveillance drug or any other component of the surveillance drug
• Patients who had a positive tuberculosis screening test but were not treated with standard therapy before participating in the study
• Patients who have a positive hepatitis virus test
• Patients who were given a live vaccine concurrently with the surveillance drug or are expected to be given a live vaccine again within 3 months after discontinuation of the surveillance drug