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| Name | Class |
|---|---|
| Epigenesys LLC | UNKNOWN |
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• Given the cost and risk associated with biologic disease modifying anti-rheumatic drugs (bDMARDs), selection of the optimal medication is imperative. Current attempts to identify genetic factors that predict bDMARD response and effectiveness in rheumatoid arthritis patients have been inconclusive. Furthermore the presence of epigenetic signatures in rheumatoid arthritis patients has not been established. This protocol is the first step to identifying the practicality and feasibility of epigenetic testing to aid in diagnosis and/or medication selection in rheumatoid arthritis patients. Subsequent research into such epigenetic changes may be indicative of bDMARD response and/or safety. If such epigenetic signatures (EGS) exist the business need for such tests will thus be supported.
Two groups of patients will be assessed for the presence unique epigenetic signatures. The test group, having a bonafide diagnosis of rheumatoid arthritis (RA) and a control group of subjects who does not fulfill the American College of Rheumatology's classification criteria for RA. A buccal cell sample and blood draw will be sequenced and analyzed from each subject in each group for the presence of epigenetic signatures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Newly diagnosed female patients with rheumatoid arthritis who have not previously used a disease modifying anti-rheumatic drug. | ||
| Control | Female patients not having a diagnosis of rheumatoid arthritis and who have not previously used a disease modifying anti-rheumatic drug. |
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| Measure | Description | Time Frame |
|---|---|---|
| Counts of patients with epigenetic signatures. | The identification of a statistically significant number of RA patients having a consistent epigenetic signature | 1 day |
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Test patient Inclusion Criteria:
Control patient Inclusion Criteria:
Exclusion Criteria:
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The study population is at-risk patients for chronic auto-immune and rheumatic disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gary L Craig, MD | Contact | 5098386500 | gcraig@arthritisnw.com | |
| Keith Knapp, PhD | Contact | 5098386500 | kknapp@arthritisnw.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis Northwest | Recruiting | Spokane | Washington | 99208 | United States |
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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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Specimens Collected:
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |