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

Sponsor
University of Cagliari
Study ID
NCT05659407
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belimumab in SLE patients / Rituximab in RA patients — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 24, 2020
Status verified
Dec 2022
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: BAFF-var carrier
  • Arm: No BAFF-var carrier

Primary Outcome Measure

BAFFs [ Time Frame: 12 months ]

Central Contacts

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