NCT04570306Completed
Transcriptional and Immune Parameters of Response to Belimumab
Whole Blood Transcriptional and Mass Cytometry Immune Profiling in Systemic Lupus Erythematosus (SLE) Patients to Discern the Salutary Effects of Belimumab on Halting Disease Progression and Flares Without Compromising Host Fitness
Source: ClinicalTrials.gov · Last updated 11 Jun 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 85 (actual)
- First submitted
- 19 Jun 2020
- Start date
- 16 Dec 2020
- Primary completion date
- 16 Dec 2023
- Lead sponsor
- Biomedical Research Foundation, Academy of Athens
- Diseases
- Lupus (SLE)
- NCT number
- NCT04570306
What you commit to
- Study type: Observational
- Participants enrolled: 85
- From 16 Dec 2020 to the primary completion date, 16 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- co-existing rheumatic or other autoimmune disease
- active infection
- history of malignant disorder
Age
- age \<18 years
Other
- pregnancy
Who the study is looking for
- who meet the Systemic Lupus International Collaborating Clinics (SLICC) 2012 and/or European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 classification criteria;
- have active disease defined as the combination of clinical (i.e., excluding serology) SLEDAI-2000 ≥6 and/or physician global assessment (PhGA) ≥1.5. Both flaring (acute exacerbation) and persistent disease activity will be considered;
- are started 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BRFAA Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.