Korean Post-marketing Surveillance for Orencia®

May 10, 2016 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Time Perspective: Prospective / Retrospective(On-treatment)

Study Type

Observational

Enrollment (Actual)

701

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with active rheumatoid arthritis
Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis
Drug: No Intervention (subjects were previously treated with Orencia®)
No Intervention
Other Names:
  • Abatacept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events occurrence
Time Frame: 30 days after last dose of study drug
30 days after last dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events and Serious Adverse Events
Time Frame: 30 days after last dose of study drug
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
Time Frame: 24 weeks of registration
* APR = acute phase reactants
24 weeks of registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

April 20, 2012

First Posted (Estimate)

April 23, 2012

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-300

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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