BAFF and APRIL and RESPONSE TO BELIMUMAB in SLE

Systemic Lupus Erythematosus Clinical Trial

— BAFF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03919643
• Other study ID #: BAFF
• Status: Not yet recruiting
• Start date: May 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: April 2019
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Francisca González- Escribano, PhD
• Phone: 0034955012144
• Email: mariaf.gonzalez.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• BAFF Polymorphism
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)