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BAFF and APRIL and RESPONSE TO BELIMUMAB in SLE

Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (Other)
Overall Status
Unknown status
CT.gov ID
NCT03919643
Collaborator
(none)
200
Enrollment
14
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    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
    Anticipated Study Start Date :
    May 1, 2019
    Anticipated Primary Completion Date :
    May 1, 2020
    Anticipated Study Completion Date :
    Jul 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
    ClinicalTrials.gov Identifier:
    NCT03919643
    Other Study ID Numbers:
    • BAFF
    First Posted:
    Apr 18, 2019
    Last Update Posted:
    Apr 18, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lupus Erythematosus, Systemic

    Study Results

    No Results Posted as of Apr 18, 2019