Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus

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

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-16

Study Completion Date

2032-12-31

Brief Summary

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The aim of this research project is to better understand the origin and clinical significance of two lupus-specific "genetic signatures" (IFN signature and plasma cell signature) in patient subgroups with well-defined clinical characteristics. Our aim is to correlate these genetic signatures with cell activation profiles and the production of specific cytokines in different populations from whole blood and in short-term cultures of these circulating cells.

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Detailed Description

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The aim of the experiment is, on the one hand, to identify and study the different cell populations from whole blood by flow cytometry and, on the other hand, to assay different cytokines in blood and urine samples from diseased (SLE) and control subjects (with non-inflammatory rheumatic diseases) in order to highlight and correlate the presence of biomarkers to disease activity or to a clinical manifestation of the disease.

In vitro studies will also be carried out on short-term cultures of PBMCs (Peripheral Blood Mononuclear Cells).

Conditions

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Lupus Nephritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Systemic Lupus Erythematosus - Lupus Nephritis Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Fulfilment of the EULAR/ACR classification criteria of SLE.
* 18 years of age or above.
* Incident or Flare biopsy-proven proliferative or membranous LN

Exclusion Criteria

* Antiphospholipid syndrome nephropathy (APSN).
* Pregnancy at baseline (pregnancy during follow-up will not lead to exclusion).
* Anticipated non-adherence to therapy.
* Medical conditions interfering with outcome evaluations.
* Inability to read and/or sign the informed consent form.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No