Korean Post-marketing Surveillance for Orencia®

Rheumatoid Arthritis Clinical Trial

Official title:

Korean Post-marketing Surveillance for Orencia®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583244
• Other study ID #: IM101-300
• Status: Completed
• Phase: N/A
• First received: April 20, 2012
• Last updated: March 8, 2016
• Start date: March 2010
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

Time Perspective: Prospective / Retrospective(On-treatment)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 701
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Local Institution	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events occurrence		30 days after last dose of study drug	Yes
Secondary	Number of Adverse Events and Serious Adverse Events		30 days after last dose of study drug	Yes
Secondary	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	24 weeks of registration	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form