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The primary goal of this study is to assess a cfDNA-based blood test using genetic, transcriptomic and/or epigenetic information to help doctors predict the best treatment options for rheumatoid arthritis (RA) patients with inadequate response or intolerance to previous therapies.
PRIMA - 102 aims to predict response to bDMARD or tsDMARD therapy through analysis of cfDNA in blood. PRIMA - 102 will enroll participants with inadequate response or intolerance to previous therapies. Participants will undergo screening and baseline visits, followed by the initiation of new bDMARD or tsDMARD therapy per standard of care. The study will evaluate treatment response and disease activity at a 12-week follow-up visit. Blood will be drawn and Clinical Outcome Assessments performed at baseline and at the 12-week follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults diagnosed with RA | Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Prediction | This study aims to identify cfDNA signatures that predict response to specific bDMARD or tsDMARD therapies for RA treatment. | Approximately 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aqtual Study Support | Contact | 341-208-8569 | studysupport@aqtual.com |
| Name | Affiliation | Role |
|---|---|---|
| Diana Abdueva | CEO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis and Osteoporosis Consultants of the Carolinas | Recruiting | Charlotte | North Carolina | 28207 | United States |
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Whole Blood & processed plasma
| 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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