BAFF and APRIL and RESPONSE TO BELIMUMAB in SLE

• Conditions: BAFF Polymorphism; Systemic Lupus Erythematosus

• Registration Number: NCT03919643
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-02-14
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-15
• Study First Posted: 2019-04-18
• Last Update Posted: 2019-04-18
• Study Start: 2019-05-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	from data of Informed consent form signature to finish of follow-up (1 Year)	Quantify physiological parameters (levels of BAFF and APRIL) in serum and urine of patients and controls by ELISA.
Correlate the transcript and protein levels with clinical manifestations and disease activity.	from data of Informed consent form signature to finish of follow-up (1 Year)	Quantify anti-dsDNA levels recording clinical symptoms and SLE-DAI (Systemic Lupus Erythematosus Disease Activity Index)
Establish the influence of certain polymorphisms in the levels of expression of different transcripts and proteins.	from data of Informed consent form signature to finish of follow-up (1 Year)	Determine the expression levels of different physiological parameters (BAFF and APRIL transcripts) in peripheral blood mononuclear cells from patients and controls.