Korean Post-marketing Surveillance for Orencia®

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: No Intervention (subjects were previously treated with Orencia®)

• 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)

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-23
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

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

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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

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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
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

Trial Locations

Locations (1)

Local Institution; 🇰🇷 Seoul, Korea, Republic of