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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Elevated Level of IFN Type I in SLE Patients
• Intervention / Treatment: Other: study of IFNGS expression biomarkers

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Tatiana Popkova, MD; Phone Number: +79859988552; Email: popkovatv@mail.ru
• Study Contact Backup: Name: Tatiana Panafidina, MD; Email: panafidina@inbox.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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)

Description

Inclusion Criteria:

1. Age 18-60 years old
2. Patients with SLE (SLICC/ACR 2012) confirmed by rheumatologist
3. Provided written informed consent before any study-related procedures are performed.
4. Ability to attend scheduled visits
5. 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:

1. Participation in any other clinical study
2. Pregnancy or pregnancy planning in next 12 months, lactation
3. Acute infectious disease or relapse of chronic infectious disease.
4. Receiving any of biologic agent or Janus-kinases inhibitors during 24 months prior to screening.
5. Active severe or unstable neuropsychiatric SLE manifestations (convulsion, psychosis, delirium, hallucinations, coma, transverse myelitis).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: V.A. Nasonova Research Institute of Rheumatology, Moscow
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: D3461L00006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No