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BAFF-var as a Biomarker of Response to B-depletive Treatment in Systemic Lupus Erythematosus and Rheumatoid Arthritis

NCT05659407 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-12-21

No results posted yet for this study

Summary

A variant of the TNFSF13B gene, commonly referred to as BAFF-var has been associated with an increased risk of developing immune-mediated diseases, such as Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA).

This polymorphism leads to the production of higher levels of BAFFs, that in turns are associated with more severe disease, high anti-Sm and anti-dsDNA titre, complement consumption, and increased risk of flare in SLE, and higher disease activity in RA.

This is a prospective study aiming to explore the immunological basis of a potential role of BAFF-var as a prognostic biomarker for response to belimumab and rituximab, the main B-depletive treatments, in SLE and RA patients, respectively. More in detail, the study aims to evaluate if the condition of BAFF-var carrier in SLE and RA patients, treated respectively, with belimumab plus standard of care or rituximab influences immunological, molecular and clinical variables, such as: (a) soluble BAFF (BAFFs) cytokine, (b) mRNA-BAFF (c) miRNA-15a (d) B-cell subpopulations (d) disease activity, as assessed by standardized clinimetric tools.

Conditions

Interventions

DRUG

Belimumab in SLE patients / Rituximab in RA patients

Belimumab and Rituximab are the the investigated treatments, respectively in the SLE and RA group. They are administrated according to the approved indications and in compliance with the current recommendations and the good clinical practice, independently to the aim of the present observational study.

Sponsors & Collaborators

  • Azienda Ospedaliero Universitaria di Cagliari

    collaborator OTHER

  • University of Cagliari

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05659407 on ClinicalTrials.gov