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Prospective, multi-center-observational study conducted within the US, collecting patient samples for research and development to train, test, and validate precision medicine classifiers. These molecular signature response classifiers (MSRC) aim to predict response status to JAK, T-cell, and IL-6 inhibitor therapies in patients with rheumatoid arthritis (RA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JAK/T-cell/IL-6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lab Collection Only | Other | 2 Paxgene and 1 SST tubes will be collected at 2 timepoints throughout the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of MSRC to predict the patients response | The rate of MSRC to predict the patients response status based on actual clinical disease activity measure at 6 months. Determine performance characteristics of the MSRC being developed, trained, and validated to predict a patient's response status to specific biologic or targeted therapies. | 6 months |
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Inclusion Criteria:
Patient is eighteen years of age, or older (≥18) at time of consent.
Patient must meet the criteria for RA as defined by the 2010ACR/EULAR classification at Visit 1 and documented by enrolling PI.
Patient has active RA, with moderate or high disease activity as confirmed by a CDAI score of >10 at Visit 1.
Patients must have a history of failure, contraindication, or intolerance to at least one csDMARD therapy.
Patient must be b/tsDMARD-naïve or TNFi-exposed prior to baseline visit only.
Patient must be initiating one of the following listed therapies (including biosimilars).
Concomitant treatments are permitted per standard of care and are not limited to the following:
a.csDMARD i.Methotrexate ii.Sulfasalazine iii.Leflunomide iv.Hydroxychloroquine b.Non-steroidal anti-inflammatory drugs c.Corticosteroids
Patient may participate in another observational study.
Patient is willing and able to complete the informed consent process and comply with all study procedures and visit schedule.
Exclusion Criteria:
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RA patients with moderate or high disease activity and are eligible for treatment with a JAK, T-cell, or IL-6 inhibitor therapy who are either naïve to biologic and targeted synthetic DMARDs or TNFi-exposed.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| April Cobb | Contact | 3363806400 | april.cobb@scipher.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medvin Clinical Research//Amicus Arthritis | Recruiting | Whittier | California | 90602 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Feb 22, 2024 | Apr 24, 2024 | Prot_ICF_000.pdf |
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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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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |