Korean Post-marketing Surveillance for Orencia®

Bristol-Myers Squibb701 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

701

Conditions

Rheumatoid Arthritis

Interventions

No Intervention (subjects were previously treated with Orencia®)DRUG

No Intervention

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Seoul, South Korea

Outcomes

Primary Outcomes

Adverse events occurrence

Time frame: 30 days after last dose of study drug

Secondary Outcomes

Number of Adverse Events and Serious Adverse Events

Time frame: 30 days after last dose of study drug

Efficacy of Orencia® measured by swollen joint counts and tender joint counts in the subject treated with the surveillance drug, patient-assessed pain, APR, patient-assessed global health, physician-assessed global disease activity

\* APR = acute phase reactants

Time frame: 24 weeks of registration

Data from ClinicalTrials.gov

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