About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

BAFF and APRIL and RESPONSE TO BELIMUMAB in SLE

Clinicaltrials.gov identifier NCT03919643

Recruitment Status Not yet recruiting

First Posted April 18, 2019

Last update posted April 18, 2019

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:Systemic Lupus Erythematosus
    BAFF Polymorphism
  • Intervention/Treatment:
  • Phase: N/A
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
  • Estimated 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
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: July 2020
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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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
  • Ages Eligible for Study: 18 to 60 Years (Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: SLE (Sistemic Lupus Disease) with and without nephritis and healthy controls
Criteria

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
Contacts

Contact: Francisca González- Escribano, PhD 0034955012144 mariaf.gonzalez.sspa@juntadeandalucia.es

Contact: Clara Rosso-Fernández, MD-PhD claram.rosso.sspa@juntadeandalucia.es

Locations
Sponsors and Collaborators

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

More Information
  • Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
  • ClinicalTrials.gov Identifier: NCT03919643 History of Changes
  • Other Study ID Numbers: BAFF
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: April 18, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: Sharing the data collected and analysed with the scientific community by publication
  • Supporting Materials: Study Protocol, Informed Consent Form (ICF)
  • Time Frame: When study is finished
  • Access Criteria: Data publication for collaborator, data base registration of results if applicable.
  • 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