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Korean Post-marketing Surveillance for Orencia®

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ClinicalTrials.gov Identifier: NCT01583244
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
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.

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

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

Study Type : Observational
Actual Enrollment : 701 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Korean Post-marketing Surveillance for Orencia®
Study Start Date : March 2010
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept
U.S. FDA Resources

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 Name: Abatacept



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

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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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

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

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01583244     History of Changes
Other Study ID Numbers: IM101-300
First Posted: April 23, 2012    Key Record Dates
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