Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Time Perspective: Prospective / Retrospective(On-treatment)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with active rheumatoid arthritis | Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention (subjects were previously treated with Orencia®) | Drug | No Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events occurrence | 30 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events and Serious Adverse Events | 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 |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Or
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Seoul | 110-756 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30484084 | Derived | Lee JS, Ahmad H, Shim SC, Bae SC, Song YW, Lee EY. High Proportion of Subjective Component to the Disease Activity Score is Associated with Favorable Response to Abatacept in Rheumatoid Arthritis. Patient. 2019 Jun;12(3):319-326. doi: 10.1007/s40271-018-0347-z. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
Not provided
Not provided
Not provided
Not provided
Not provided
* APR = acute phase reactants |
| 24 weeks of registration |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |