BAFF and APRIL and RESPONSE TO BELIMUMAB in SLE

Study Overview
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Brief Summary
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This project is intended to identify the routes on which BAFF and APRIL act in order to detect possible future candidates to Belimumab treatment among patients diagnosed of SLE.

Detailed Description
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DESIGN Establish the influence of certain polymorphisms in the levels of expression of different transcripts and proteins. Quantify the levels of B cell activating factor belonging to the TNF family (BAFF) and a proliferation-inducing ligand (APRIL) in serum and urine of patients and controls by Enzyme-Linked Immunosorbent Assay (ELISA). BAFF Determine the expression levels of different BAFF and APRIL transcripts in peripheral blood mononuclear cells from patients and controls using a digital PCR (polymerase chain reaction) system. Compare distribution of gene polymorphisms in BAFF and APRIL in patients and controls. by sequencing the exome of the ligand and receptor genes using next generation sequencing (NGS). Correlate the transcript and protein levels with clinical manifestations and disease activity. The results of the quantification of anti- double-stranded deoxyribonucleic acid.(dsDNA) antibody levels tests will be recorded together with those demographics, clinical-epidemiological and response to the treatment.data.

Official Title
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B Cell Activating Factor Belonging to the TNF (Tumor Necrosis Factor) Family (BAFF) and a Proliferation-inducing Ligand (APRIL) in Patients With Systemic Lupus Erythematosus: Investigating Biomarkers for the Response to the Belimumab Treatment

Conditions
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Systemic Lupus Erythematosus, BAFF Polymorphism

Participation Criteria
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Eligibility Criteria
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Inclusion criteria Women18-60 years old For patients only treated with conventional drugs (without immunosuppressive or biological treatment ) For Healthy controls: no autoimmune diseases (blood donors) diagnoses

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SLE patients with nephritis<br>No intervention. Peripheral blood and urine samples will be obtained | |
| SLE patients with without nephritis<br>No intervention. Peripheral blood and urine samples will be obtained | |
| Healthy controls (blood donors)<br>No intervention. Peripheral blood and urine samples will be obtained | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve knowledge of B Cell activating factor belonging to the TNF (Tumor necrosis factor) family (BAAF) system in order to identify those SLE (Systemic Lupus Erythematous) patients that are candidate for treatment with anti-BAFF. | Quantify physiological parameters (levels of BAFF and APRIL) in serum and urine of patients and controls by ELISA. | from data of Informed consent form signature to finish of follow-up (1 Year) | 
| Establish the influence of certain polymorphisms in the levels of expression of different transcripts and proteins. | Determine the expression levels of different physiological parameters (BAFF and APRIL transcripts) in peripheral blood mononuclear cells from patients and controls. | from data of Informed consent form signature to finish of follow-up (1 Year) | 
| Correlate the transcript and protein levels with clinical manifestations and disease activity. | Quantify anti-dsDNA levels recording clinical symptoms and SLE-DAI (Systemic Lupus Erythematosus Disease Activity Index) | from data of Informed consent form signature to finish of follow-up (1 Year) |