Rheumatoid Arthritis
Conditions
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)
Interventions
DRUGNo Intervention (subjects were previously treated with Orencia®)
No Intervention
Sponsors
Bristol-Myers Squibb
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events occurrence | 30 days after last dose of study drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | \* APR = acute phase reactants |
Countries
South Korea
Outcome results
None listed