Evaluation of Type I IFN Level and Disease Activity in SLE Patients
- Conditions
- Elevated Level of IFN Type I in SLE Patients
- Interventions
- Other: study of IFNGS expression biomarkers
- Registration Number
- NCT05446428
- Lead Sponsor
- V.A. Nasonova Research Institute of Rheumatology, Moscow
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Any SLE Disease Activity study of IFNGS expression biomarkers - Moderate to severe SLE Disease Activity study of IFNGS expression biomarkers -
- Primary Outcome Measures
Name Time Method Pathogenetic, clinical and prognostic significance of IFN stimulated genes expression - IFNGS biomarkers in SLE patients Sept 1 2022 - Nov 1 2022 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.
- Secondary Outcome Measures
Name Time Method Rate of IFN stimulated genes Nov 1 2022 - Oct 31 2024 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.
IFN stimulated genes hyper-expression and serum biomarkers level Nov 1 2022 - Oct 31 2024 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.
IFNGS Nov 1 2022 - Oct 31 2024 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.