Korean Post-marketing Surveillance for Orencia®
1 other identifier
observational
701
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 20, 2012
CompletedFirst Posted
Study publicly available on registry
April 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMay 12, 2016
March 1, 2016
5.9 years
April 20, 2012
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events occurrence
30 days after last dose of study drug
Secondary Outcomes (2)
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
Study Arms (1)
Patients with active rheumatoid arthritis
Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis
Interventions
No Intervention
Eligibility Criteria
Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Seoul, 110-756, South Korea
Related Publications (1)
Lee JS, Ahmad H, Shim SC, Bae SC, Song YW, Lee EY. High Proportion of Subjective Component to the Disease Activity Score is Associated with Favorable Response to Abatacept in Rheumatoid Arthritis. Patient. 2019 Jun;12(3):319-326. doi: 10.1007/s40271-018-0347-z.
PMID: 30484084DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2012
First Posted
April 23, 2012
Study Start
March 1, 2010
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
May 12, 2016
Record last verified: 2016-03