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BAFF and APRIL and RESPONSE TO BELIMUMAB in SLE

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03919643
Acronym
BAFF
Enrollment
200
Registered
2019-04-18
Start date
2019-05-01
Completion date
2020-07-01
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BAFF Polymorphism, Systemic Lupus Erythematosus

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.

Interventions

None listed

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.
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.
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)

Contacts

Primary ContactFrancisca González- Escribano, PhD
mariaf.gonzalez.sspa@juntadeandalucia.es0034955012144
Backup ContactClara Rosso-Fernández, MD-PhD
claram.rosso.sspa@juntadeandalucia.es

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026