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Transcriptional and Immune Parameters of Response to Belimumab

NCT04570306 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2024-06-11

No results posted yet for this study

Summary

The investigators propose to perform RNA-sequencing of the whole blood initially, in a cohort of 80 SLE patients who will receive belimumab as part of standard clinical practice, in order to assess intra-patient longitudinal (baseline, 1, 3 and 6 months) transcriptome changes and examine whether treatment can ameliorate the activity/flare, severity and major organ disease gene signatures. The investigators will also obtain preliminary information on molecular signatures predicting clinical responses and the impact of belimumab on gene signatures of host defense against viral and bacterial (including mycobacterial) pathogens. Using modules of cell type-specific genes and co-expression gene networks, The investigators will deconvolute our data to define pertinent molecular alterations in specific immune cell types. Results will be validated and functionally characterized by single-cell mass cytometry (performed at the aforementioned time points), which enables investigation of the cell identity (including subsets of B-cells and myeloid cells of particular relevance to the disease) and activation status at protein level (e.g. phosphorylation) through next-generation, high-dimensional flow cytometry. Through a focused analysis followed by targeted gene expression and function studies in purified monocytes, the investigators will determine whether belimumab can restore "SLE-primed" monocytes thus, alleviating their inflammatory and pro-atherogenic phenotype and enhancing their bactericidal activity. Collectively, these studies will provide novel mechanistic insights on the beneficial efficacy/toxicity ratio of belimumab therapy in SLE.

Conditions

Interventions

DRUG

Belimumab

The study will involve 80 adult patients diagnosed with SLE who will be started on belimumab (standard approved dose of i.v. 10 mg/kg or subcutaneous 200 mg/week) due to active disease. The intention to start belimumab will be made by the treating Rheumatologist(s), in accordance to the current standard of care, and on the basis of shared physician-patient decision making.

Sponsors & Collaborators

  • Attikon Hospital

    collaborator OTHER

  • University Hospital of Heraklion

    collaborator UNKNOWN

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Biomedical Research Foundation, Academy of Athens

    lead OTHER

Principal Investigators

  • Dimitrios T Boumpas, MD · Biomedical Research Foundation, Academy of Athens

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2023-12-16
Completion
2023-12-16
FDA Drug
Yes

Countries

  • Greece

Study Locations

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Entities

Diseases
Companies

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 NCT04570306 on ClinicalTrials.gov