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BAFF Levels and Lupus Nephritis (LN)

NCT04369495 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2024-05-13

No results posted yet for this study

Summary

B-cell activating factor (BAFF), serves as a vital survival and differentiation factor for normal B-cell development. BAFF levels have been associated with the clinical activity of SLE in humans. BAFF plays a pathogenic role in SLE in part through T cell-dependent B cell autoantibody production. BAFF, has a role in the maintenance of memory B cells and promotes plasma cell survival. Treatment strategies involving BAFF blockade haven been studied in patients with SLE inducing overall improvement in disease activity, mainly in musculoskeletal and mucocutaneous domains leading to the approval of Belimumab for the treatment of patients with SLE without severe renal or neurological involvement.

Antibodies against CD20 molecule, (Rituximab), cyclophosphamide (CYC), and mycophenolate (MMF) have all been used for the treatment of different manifestations of SLE and both moderate and severe activity. Baseline C4 level, early normalization of complement, and reduction in proteinuria have been shown to predict renal response to therapy with MMF or CYC in lupus nephritis. With Rituximab (RTX), B cell depletion has been associated with response to treatment and relapse prediction. The elevation of serum BAFF levels after B cell depletion with RTX in SLE are associated with anti-double-stranded DNA antibody levels and disease flare. The rise of BAFF is probably due to the decrease in its receptors leading to a release of BAFF and a delayed regulation of BAFF mRNA transcription, both of which could favor the re-emergence of autoreactive B cells. It has been suggested that the rise in BAFF levels after anti-CD20 therapy might be related to flares of the disease. Additionally, the combination of anti-CD20 with anti-BAFF or antibodies against CD4, reduces the number of splenic plasma cells in mouse models and has been proven to have a lasting benefit both in lupus-prone mice and in mice with established disease. Currently, there is a lack of information regarding MMF or CYC and BAFF levels. We consider that it is fundamental to know the behavior of BAFF in patients with SLE after treatment with MMF or CYC bearing in mind the proposal of multiple experts of the possible use of sequential therapy of BAFF inhibition after B-cell depletion. Knowledge of the behavior of BAFF will allow me to better understand its implications in SLE and its therapy and postulate the use of sequence therapy with Belimumab after CYC o MF induction with the proposal to reduce the flares

Conditions

Interventions

OTHER

BAFF serum levels

BAFF levels in serum in visit 0,1,2 during induction therapy

Sponsors & Collaborators

  • ARTMEDICA

    collaborator UNKNOWN

  • Universidad de Antioquia

    lead OTHER

Principal Investigators

  • Gloria Vasquez, MD, DrSc · Universidad de Antioquia

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2022-03-31
Completion
2023-01-31

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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 NCT04369495 on ClinicalTrials.gov