Korean Post-marketing Surveillance for Orencia®
This study is currently recruiting participants.
Verified July 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
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
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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:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Abatacept
U.S. FDA Resources
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
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 June 18, 2013