BAFF and APRIL and RESPONSE TO BELIMUMAB in SLE (BAFF)

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

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.

Study Overview

• Status: Unknown
• Conditions: Systemic Lupus Erythematosus; BAFF Polymorphism

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Francisca González- Escribano, PhD; Phone Number: 0034955012144; Email: mariaf.gonzalez.sspa@juntadeandalucia.es
• Study Contact Backup: Name: Clara Rosso-Fernández, MD-PhD; Email: claram.rosso.sspa@juntadeandalucia.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

SLE (Sistemic Lupus Disease) with and without nephritis and healthy controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
SLE patients with nephritis; No intervention. Peripheral blood and urine samples will be obtained
SLE patients with without nephritis; No intervention. Peripheral blood and urine samples will be obtained
Healthy controls (blood donors); No intervention. Peripheral blood and urine samples will be obtained

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Publications and helpful links

General Publications

• Ortiz-Aljaro P, Montes-Cano MA, Garcia-Lozano JR, Aquino V, Carmona R, Perez-Florido J, Garcia-Hernandez FJ, Dopazo J, Gonzalez-Escribano MF. Protein and functional isoform levels and genetic variants of the BAFF and APRIL pathway components in systemic lupus erythematosus. Sci Rep. 2022 Jul 2;12(1):11219. doi: 10.1038/s41598-022-15549-0.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2019
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (ACTUAL): April 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: BAFF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing the data collected and analysed with the scientific community by publication
• IPD Sharing Time Frame: When study is finished
• IPD Sharing Access Criteria: Data publication for collaborator, data base registration of results if applicable.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No