BAFF and APRIL and RESPONSE TO BELIMUMAB in SLE

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Unknown

Conditions

BAFF Polymorphism

Systemic Lupus Erythematosus

Study type

Observational

Funder types

Other

Identifiers

NCT03919643

BAFF

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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