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Database analysis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA patients treated by Orencia | RA patients treated by Orencia according to usual practice from June 1st 2007 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orencia | Drug | No Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with first clinically significant Disease Activity Score (DAS) change | Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≥ 1.2 DAS28 will be measured every 6 months during 5 years | Up to 5 Years |
| Number of patients with first response to treatment [according to definition of European League Against Rheumatism (EULAR) response criteria] | EULAR response will be measured every 6 months during 5 years | Up to 5 Years |
| Number of patients with first Low Disease Activity State (LDAS) | Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation ≤ 3.2 DAS28 will be measured every 6 months during 5 years | Up to 5 Years |
| Number of patients with first Remission state | Change from DAS28 [C - reactive protein (CRP) and erythrocyte sedimentation rate (ESR)] measured at treatment initiation <2.6 DAS28 will be measured every 6 months during 5 years | Up to 5 Years |
| Number of patients disease progression with prior improvement | Up to 5 Years | |
| Number of patients disease progression with no prior improvement | Up to 5 Years | |
| Number of patients with modification of Orencia administration condition | Up to 5 Years |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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Patients included in SFR's ORA Registry
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Number of patients discontinued and switched from Orencia | Up to 5 Years |
| Incidence rate of any type of Adverse events related to Orencia | Up to 5 Years |
| Number of patients with specific predefined events | Predefined events are severe infection, thromboembolic events, cancer, lymphoma, other autoimmune disease, cutaneous disorder, significant or persistent disability, death | Up to 5 Years |
| Response over the time will be assessed over 5 years on EULAR response, LDAS | Up to 5 years |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
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