Korean Post-marketing Surveillance for Orencia®

Bristol-Myers Squibb1 site in 1 country701 target enrollmentMarch 2010

ConditionsRheumatoid Arthritis

InterventionsNo Intervention (subjects were previously treated with Orencia®)

DrugsNo Intervention (subjects were previously treated with Orencia®)

Overview

Phase: Not Applicable
Intervention: No Intervention (subjects were previously treated with Orencia®)
Conditions: Rheumatoid Arthritis
Sponsor: Bristol-Myers Squibb
Enrollment: 701
Locations: 1
Primary Endpoint: Adverse events occurrence
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

Time Perspective: Prospective / Retrospective(On-treatment)

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

February 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Arms & Interventions

Patients with active rheumatoid arthritis

Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis

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

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(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(24 weeks of registration)