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

V.A. Nasonova Research Institute of Rheumatology, Moscow

Status: Not yet enrolling

Conditions: Elevated Level of IFN Type I in SLE Patients

Treatments: Other: study of IFNGS expression biomarkers

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05446428

D3461L00006

Details and patient eligibility

About

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).

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

70 participants in 2 patient groups

Any SLE Disease Activity

Treatment:

Other: study of IFNGS expression biomarkers

Moderate to severe SLE Disease Activity

Treatment:

Other: study of IFNGS expression biomarkers