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The purpose of this study is to assess the clinical response to IL-6 inhibition defined as Low Disease Activity (DAS44) <2.4) at the follow-up visit at 12 months and the correlation between the biomarkers and treatment response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Other | Biomarkers Measures At the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarkers Measures | Other | At the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score (DAS-44) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Simplified Disease Activity Index (SDAI);Biomarkers Measures | SDAI at 3-6-12-18 months | |
| Biomarkers Measures | Evaluation by ELISA of the levels of the following biomarkers: IL-8, MCP-1, Chemerin, IL-1α, IL-1β, IL-17, IL-23, TGFβ1, IL-10, BAFF.in the plasma: |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Lapadula, Prof. | Contact | +39 080 5478866 | info@oegisea.it |
| Name | Affiliation | Role |
|---|---|---|
| Gianfranco Ferraccioli, Prof. | Dipartimento di Reumatologia, Università Cattolica del Sacro Cuore, Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università Cattolica del Sacro Cuore | Recruiting | Roma | Italy |
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| Biomarkers Measures at 3-6-12-18 months |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D007266 | Inhibition, Psychological |
| 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 |
| D001519 | Behavior |
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