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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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Elevated level of IFN type I in SLE patients associated with certain serum biomarkers (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α, TNF-RII, BAFF, APRIL), clinical and laboratory manifestations, activity and duration pf the disease and SLE patients quality of life. Standard immunosuppressive and anti-B-cell therapy can reduce the IFN type I and associated biomarkers levels in patients with high and moderate disease activity (SLEDAI-2К ≥6).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Any SLE Disease Activity |
| ||
| Moderate to severe SLE Disease Activity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| study of IFNGS expression biomarkers | Other | Blood tests for serum biomarkers, autoantibodies, cytokine profile etc. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pathogenetic, clinical and prognostic significance of IFN stimulated genes expression - IFNGS biomarkers in SLE patients | Pathogenetic, clinical and prognostic significance of IFN stimulated genes expression - IFNGS biomarkers (IFI44L, MX1, IFIT 1, RSAD2, EPSTI1), serum biomarkers (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α), TNF-α receptors type II (TNF-RII), В-cell activation factors (BAFF, APRIL) in SLE patients. | Sept 1 2022 - Nov 1 2022 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of IFN stimulated genes | Rate of IFN stimulated genes hyper-expression, serum biomarkers level (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α), TNF-α receptors type II level (TNF-RII), В-cell activation factors level (BAFF, APRIL) in SLE patient's blood. | Nov 1 2022 - Oct 31 2024 |
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Inclusion Criteria:
Exclusion Criteria:
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70 adult patients with SLE who receive inpatient or outpatient саre from 01.06.2022 (1 stage) 30 of them with moderate to severe disease activity (SLEDAI 2К ≥6) will be included in prospective observation (2 stage 01.06.2022-25.12.2023)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tatiana Popkova, MD | Contact | +79859988552 | popkovatv@mail.ru | |
| Tatiana Panafidina, MD | Contact | panafidina@inbox.ru |
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| IFN stimulated genes hyper-expression and serum biomarkers level | IFN stimulated genes hyper-expression and serum biomarkers level (galectin -1,-3,-9; cytokine profile - 20 plex panel - GM-CSF, IFN-γ, IL-2, -4,-5,-6,-7,-8,-10,-13,-15,-17,-18, IP-10. MCP-1, MIG, MIP-1α, MIP-1β, RANTES, TNF-α), TNF-α receptors type II level (TNF-RII), В-cell activation factors level (BAFF, APRIL) associated with SLE clinical and laboratory manifestations (such as muco-cutaneous, joints, renal, hematological, immunological et ctr.), disease activity (assessed with SLEDAI-2k) and duration, patients' quality of life. | Nov 1 2022 - Oct 31 2024 |
| IFNGS | IFNGS alone or as a part of complex poly-parametric indexes is a predictor of standard immunosuppressive and anti-B-cell therapy effectiveness in SLE and flares prevention. | Nov 1 2022 - Oct 31 2024 |