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

NCT ID: NCT05446428

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elevated Level of IFN Type I in SLE Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Any SLE Disease Activity

study of IFNGS expression biomarkers

Intervention Type OTHER

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

Moderate to severe SLE Disease Activity

study of IFNGS expression biomarkers

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

study of IFNGS expression biomarkers

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role collaborator

V.A. Nasonova Research Institute of Rheumatology, Moscow

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Popkova Tatiana

MD PhD Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tatiana Popkova, MD

Role: CONTACT

+79859988552

Tatiana Panafidina, MD

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D3461L00006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

T Regulatory Cells IN LUPUS NEPHRITIS
NCT06428539 NOT_YET_RECRUITING