Korean Post-marketing Surveillance for Orencia®

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01583244
First received: April 20, 2012
Last updated: July 30, 2012
Last verified: July 2012
  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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Adverse Events and Serious Adverse Events [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    * APR = acute phase reactants


Estimated Enrollment: 600
Study Start Date: July 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 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

  Eligibility

Genders Eligible for Study:   Both
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

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
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 ClinicalTrials.gov identifier: NCT01583244

Contacts
Contact: For Site information please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

Locations
Korea, Republic of
Local Institution Not yet recruiting
Chonju, Chonbuk, Korea, Republic of, 561-712
Contact: , Site 014         
Local Institution Not yet recruiting
Cheonan, Chungcheongnam-do, Korea, Republic of, 330-715
Contact: , Site 013         
Local Institution Not yet recruiting
Cheonan, Chungcheongnam-do, Korea, Republic of, 330-721
Contact: , Site 016         
Local Institution Not yet recruiting
Goyang, Gyeonggi-do, Korea, Republic of, 411-706
Contact: , Site 021         
Local Institution Not yet recruiting
Guri, Gyeonggi-do, Korea, Republic of, 471-701
Contact: , Site 004         
Local Institution Not yet recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 443-721
Contact: , Site 023         
Local Institution Not yet recruiting
Busan, Korea, Republic of, 602-812
Contact: , Site 006         
Local Institution Not yet recruiting
Busan, Korea, Republic of, 614-735
Contact: , Site 009         
Local Institution Not yet recruiting
Daejeon, Korea, Republic of, 302-799
Contact: , Site 017         
Local Institution Not yet recruiting
Gwangju, Korea, Republic of, 501-717
Contact: , Site 015         
Local Institution Not yet recruiting
Pusan, Korea, Republic of, 602-739
Contact: , Site 007         
Local Institution Not yet recruiting
Pusan, Korea, Republic of, 608-838
Contact: , Site 008         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 135-710
Contact: , Site 012         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 134-727
Contact: , Site 011         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 130-872
Contact: , Site 019         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 130-872
Contact: , Site 020         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 130-872
Contact: , Site 018         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 137-701
Contact: , Site 022         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 133-792
Contact: , Site 005         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 139-872
Contact: , Site 003         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 110-744
Contact: , Site 002         
Local Institution Recruiting
Seoul, Korea, Republic of, 110-744
Contact: , Site 001         
Local Institution Not yet recruiting
Ulsan, Korea, Republic of, 682-714
Contact: , Site 010         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01583244     History of Changes
Other Study ID Numbers: IM101-300
Study First Received: April 20, 2012
Last Updated: July 30, 2012
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 23, 2014