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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
The purpose of this study is to examine the effectiveness and safety of the abatacept administration in biologic-naïve rheumatoid arthritis patients who have moderate disease activity despite treatments with conventional synthetic disease modified anti-rheumatic drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORENCIA with Exposure | ORENCIA with Exposure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORENCIA Subcutaneous Injection | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of achievement in low disease activity by simplified disease activity index (SDAI). | 52 Weeks | |
| Change in the percentage of disease activity category by simplified disease activity index(SDAI) | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
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Inclusion Criteria:
Patients with RA who meet the 2010 American College of Rheumatology / European League against Rheumatisms (ACR/EULAR) RA Classification Criteria
Patients with RA with a moderate disease activity (SDAI: > 11 and 26)
Biologic-naive patients with treatment history csDMARDs
Patients who meet the following criteria by hematological examination:
Patients who understand the investigator's explanation of study procedures and have given voluntary written consent to participate in this study
Patients initiated with abatacept at per their physician's therapeutic decision
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Minato-ku | Tokyo | 1070052 | Japan | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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Whole Blood
| Change in the percentage of disease activity category by clinical disease activity index(CDAI) | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in the percentage of disease activity category by disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR) | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in the percentage of disease activity category by disease activity score with 28 joint counts creactive protein (DAS28-CRP) | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in simplified disease activity index(SDAI) | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in clinical disease activity index(CDAI) | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR) | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in disease activity score with 28 joint counts Creactive protein (DAS28-CRP) | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in Anti-citrullinated protein antibodies (ACPA) | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in Rheumatoid factors (RF) | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Survival rate | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Hospitalization rate | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Number of occurrences of rheumatoid arthritis related surgery | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Persistence rate of Abatacept treatment | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Reasons for discontinuation of Abatacept treatment | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in Japanese Health Assessment Questionnaire | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in European Quality of Life 5 Dimension Questionnaire | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in Pain visual analog scale | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in General visual analog scale | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Change in PRO parameters defined in IORRA registry (JMAJ 2009 52 (1) 54-56) | 0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months |
| Minato-ku |
| Tokyo |
| 1070052 |
| Japan |
| 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 |