Korean Post-marketing Surveillance for Orencia®
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT01583244
- Lead Sponsor
- Bristol-Myers Squibb
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 701
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with active rheumatoid arthritis No Intervention (subjects were previously treated with Orencia®) Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis
- Primary Outcome Measures
Name Time Method Adverse events occurrence 30 days after last dose of study drug
- Secondary Outcome Measures
Name Time Method 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 \* APR = acute phase reactants
Number of Adverse Events and Serious Adverse Events 30 days after last dose of study drug
Trial Locations
- Locations (1)
Local Institution
🇰🇷Seoul, Korea, Republic of
Local Institution🇰🇷Seoul, Korea, Republic of