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| Name | Class |
|---|---|
| Perseid Therapeutics LLC | UNKNOWN |
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The purpose of this study is to characterize CD86 receptor occupancy in subjects with rheumatoid arthritis (RA) receiving abatacept.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with RA initiating abatacept treatment regimen | Subjects naïve to both abatacept and belatacept |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abatacept | Drug | Intravenous Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| CD86 Receptor Occupancy | Day 1, Weeks 2, 4, 8, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| CD80 Receptor Occupancy | Day 1, Weeks 2, 4, 8, and 12 | |
| Abatacept serum concentration | Day 1, Weeks 2, 4, 8 and 12 | |
| Change from Day 1 to Week 12 in Subject's Global Assessment of Arthritis |
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Inclusion Criteria:
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Subjects with Rheumatoid Arthritis
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development | Study Director |
| Principal Investigator | Metroplex Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Arthritis Research of Florida |
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whole blood, serum
| Day 1 and Week 12 |
| Change from Day 1 to Week 12 in Physician's Global Assessment of Arthritis | Day 1 and Week 12 |
| Safety assessed by adverse event reporting including Physical Examination findings | Day 1 through Week 12 post-infusion |
| Palm Harbor |
| Florida |
| 34684 |
| United States |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | United States |
| North Shore - Long Island Jewish Health System | Lake Success | New York | 11042 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Low County Rheumatology | North Charleston | South Carolina | 29406 | United States |
| Metroplex Clinical Research Center | Dallas | Texas | 75231 | United States |
| 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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