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OpenTrials
Completed

NCT Number: NCT01583244

Korean Post-marketing Surveillance for Orencia®

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Seoul, 110-756, South Korea

About this study

Time Perspective: Prospective / Retrospective(On-treatment)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Intervention (subjects were previously treated with Orencia®)

Drug

No Intervention

Other names: Abatacept

Primary outcomes

  1. Adverse events occurrence

    Time frame: 30 days after last dose of study drug

Secondary outcomes

  1. Number of Adverse Events and Serious Adverse Events

    Time frame: 30 days after last dose of study drug

  2. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Apr 23, 2012
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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