An observational study in Systemic Lupus Erythematosus and BAFF Polymorphism, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Status unknown. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-18.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational
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.
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 200 is above the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 119 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
SLE (Sistemic Lupus Disease) with and without nephritis and healthy controls
Inclusion criteria
No intervention. Peripheral blood and urine samples will be obtained
No intervention. Peripheral blood and urine samples will be obtained
No intervention. Peripheral blood and urine samples will be obtained
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.
Time frame: 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.
Time frame: 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)
Time frame: from data of Informed consent form signature to finish of follow-up (1 Year)
No study locations are listed for this record.
Plan to share: Yes — Sharing the data collected and analysed with the scientific community by publication
Supporting information: Study protocol, Icf
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla