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Korean Post-marketing Surveillance for Orencia®

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: April 20, 2012
Last updated: May 10, 2016
Last verified: March 2016
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.

Condition Intervention
Rheumatoid Arthritis
Drug: No Intervention (subjects were previously treated with Orencia®)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Korean Post-marketing Surveillance for Orencia®

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Adverse events occurrence [ Time Frame: 30 days after last dose of study drug ]

Secondary Outcome Measures:
  • Number of Adverse Events and Serious Adverse Events [ Time Frame: 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

Enrollment: 701
Study Start Date: March 2010
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Abatacept

Detailed Description:
Time Perspective: Prospective / Retrospective(On-treatment)

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis

For more information regarding BMS clinical trial participation, please visit

Inclusion Criteria:

  • 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01583244

Korea, Republic of
Local Institution
Seoul, Korea, Republic of, 110-756
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01583244     History of Changes
Other Study ID Numbers: IM101-300
Study First Received: April 20, 2012
Last Updated: May 10, 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 23, 2017