Evaluation of Type I IFN Level and Disease Activity in SLE Patients
NCT ID: NCT05446428
Last Updated: 2022-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
70 participants
OBSERVATIONAL
2022-08-01
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Any SLE Disease Activity
study of IFNGS expression biomarkers
Blood tests for serum biomarkers, autoantibodies, cytokine profile etc.
Moderate to severe SLE Disease Activity
study of IFNGS expression biomarkers
Blood tests for serum biomarkers, autoantibodies, cytokine profile etc.
Interventions
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study of IFNGS expression biomarkers
Blood tests for serum biomarkers, autoantibodies, cytokine profile etc.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
60 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
V.A. Nasonova Research Institute of Rheumatology, Moscow
OTHER
Responsible Party
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Popkova Tatiana
MD PhD Professor
Central Contacts
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Other Identifiers
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D3461L00006
Identifier Type: -
Identifier Source: org_study_id
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