Evaluation of Type I IFN Level and Disease Activity in SLE Patients

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of Type I IFN Level and Disease Activity in SLE Patients

Conditions
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Elevated Level of IFN Type I in SLE Patients

Intervention / Treatment
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* Other: study of IFNGS expression biomarkers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-60 years old Patients with SLE (SLICC/ACR 2012) confirmed by rheumatologist Provided written informed consent before any study-related procedures are performed. Ability to attend scheduled visits No positive changes in the course of standard of care SLE therapy (glucocorticoids in stable doses, hydroxychloroquine and/or immunosuppressant therapy) at least 30 days before screening. Exclusion Criteria: Participation in any other clinical study Pregnancy or pregnancy planning in next 12 months, lactation Acute infectious disease or relapse of chronic infectious disease. Receiving any of biologic agent or Janus-kinases inhibitors during 24 months prior to screening. Active severe or unstable neuropsychiatric SLE manifestations (convulsion, psychosis, delirium, hallucinations, coma, transverse myelitis).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Any SLE Disease Activity<br> | Other: study of IFNGS expression biomarkers<br>* Blood tests for serum biomarkers, autoantibodies, cytokine profile etc.<br>|
| Moderate to severe SLE Disease Activity<br> | Other: study of IFNGS expression biomarkers<br>* Blood tests for serum biomarkers, autoantibodies, cytokine profile etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |