NCT06327724

Belimumab in SLE Synovial Inflammation and Lymph Nodes

The Effects of Belimumab on Synovial Inflammation and Composition of Lymph Nodes in SLE Patients
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
Belimumab
Study type
Observational
Intervention type
drug
Sponsor & location
Primary sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Location
Amsterdam, Netherlands
Timeline & enrollment
Phase
N/A
Start date
Sep 01, 2023
End date
Mar 01, 2025
Enrollment
15 participants
Primary outcome

Differences in lymph node cellular composition as assessed by advanced flow cytometry

Summary

Systemic lupus erythematosus (SLE)is an immune-mediated inflammatory disease (IMIDs) of which
 the cellular and molecular alterations of the immune system driving the diseases still
 remains largely unknown. Accordingly, it remains difficult to predict the individual
 patient's response to treatment. Moreover, the patient's response to treatment remains
 heterogeneous and difficult to predict, despite the development of a variety of novel and
 powerful drugs (including the so-called biologicals). Therefore, there is a clear need for
 the identification and validation of cellular and molecular biomarkers which can provide
 useful clinical information for diagnosis, classification, prognosis and treatment, as well
 as the development of new therapeutic strategies. Biomarkers can be found and analyzed in
 different body compartments, of which the peripheral blood and the intra-articular synovial
 fluid or tissue are most easily accessible. However, previous studies in RA and other IMIDs
 showed that adaptive immune responses in other tissues such as lymph nodes also play an
 important role. Investigating other immune compartments of the body such as the lymph nodes
 could result in new insights. To study the early pathogenesis of inflammatory conditions, in
 2008 our department initiated core-needle inguinal lymph node biopsy sampling. Since then
 more than 100 lymph node biopsy procedures were performed. The procedure is well-tolerated
 and, other than a small hematoma which does not require therapy in most of the cases, no
 complications were reported.
 
 In the current study, the effects of belimumab (anti-BAFF) in SLE will be investigated by
 studying the immune alterations taking place in lymph nodes in comparison to peripheral blood
 and immune alterations taking place in the end-organ, e.g. the joint (wrist, knee or ankle)
 by taking synovial biopsies during a needle- or mini-arthroscopy. This procedure has been
 performed frequently in our department over the last 15 years. In this way immune alterations
 in the lymph nodes (secondary lymphoid organ), peripheral blood (systemic) and the joint (end
 organ for the disease) will be assessed and compared.

ICD-10 classifications
Systemic lupus erythematosusSystemic lupus erythematosus, unspecifiedLupus erythematosusSystemic lupus erythematosus with organ or system involvementOther forms of systemic lupus erythematosus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06327724
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06327724 through Pure Global AI's free database. This phase not specified trial is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) and is currently Recruiting. The study focuses on Systemic Lupus Erythematosus. Target enrollment is 15 participants.

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