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

Sponsor

V.A. Nasonova Research Institute of Rheumatology, Moscow (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05446428

Collaborator

AstraZeneca (Industry)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Elevated Level of IFN Type I in SLE Patients	Other: study of IFNGS expression biomarkers

Study Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Any SLE Disease Activity	Other: study of IFNGS expression biomarkers Blood tests for serum biomarkers, autoantibodies, cytokine profile etc.
Moderate to severe SLE Disease Activity	Other: study of IFNGS expression biomarkers Blood tests for serum biomarkers, autoantibodies, cytokine profile etc.

Arm

Intervention/Treatment

Any SLE Disease Activity

Other: study of IFNGS expression biomarkers

Blood tests for serum biomarkers, autoantibodies, cytokine profile etc.

Moderate to severe SLE Disease Activity

Other: study of IFNGS expression biomarkers

Blood tests for serum biomarkers, autoantibodies, cytokine profile etc.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

V.A. Nasonova Research Institute of Rheumatology, Moscow
AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Popkova Tatiana, MD PhD Professor, V.A. Nasonova Research Institute of Rheumatology, Moscow

ClinicalTrials.gov Identifier:

NCT05446428

Other Study ID Numbers:

D3461L00006

First Posted:

Jul 6, 2022

Last Update Posted:

Jul 6, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Jul 6, 2022