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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
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The purpose of this study is to know the level of expression and activation state of different transcription factors of the STAT family (STAT1, STAT3, STAT5A, STAT5B, STAT6) in the hematopoietic cells from tocilizumab treated patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab treated patients | Rheumatoid arthritis patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in the levels of phosphorylation of STAT proteins on peripheral blood leukocytes | The levels of phosphorylation of STATs on different subsets of leukocytes will be assessed by flow cytometry at baseline (before Tocilizumab administration) and at the indicated time (6m) after initiation of treatment. Results will be expressed as Mean of Fluorescence Intensity. To perform the analysis the investigators will use conjugated monoclonal antibodies against STAT1, STAT3, STAT5 and STAT6 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Main change in plasma level of IL-2, IL-4, IL-6, IL-10, IL-17, TNFα, IFNα, IFNγ,MCP-1 and IL-1 | Baseline, at month 6 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
Intraarticular (IA) corticosteroids within 8 weeks prior to screening. Intramuscular (IM) or IV corticosteroids within 12 weeks prior to screening.
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Patients with RA who are going to commence treatment with Ro-Actemra® (Tocilizumab). All patients initiating treatment will be considered for the study if they fulfill all inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Vidal, PhD | Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Barcelona | 08025 | Spain |
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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 |