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Korean Post-marketing Surveillance for Orencia®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01583244
First Posted: April 23, 2012
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583244


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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01583244     History of Changes
Other Study ID Numbers: IM101-300
First Submitted: April 20, 2012
First Posted: April 23, 2012
Last Update Posted: May 12, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents