RecruitingNCT07056621

Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study


Sponsor

Biomedical Research Foundation, Academy of Athens

Enrollment

684 participants

Start Date

Jun 30, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This will be a combined retrospective and prospective cohort study, that will evaluate the incidence of de novo Systemic Lupus Erythematosus major organ manifestations (defined as BILAG A flares) in patients receiving belimumab (Arm A) and compare it to 2 standard-of-care groups (SoC) (Arm B: patients on SoC; Arm C: patients on SoC followed-up up to May 1st 2014, the first date where belimumab was available in Greece). The investigators will utilize survival analysis methods (Kaplan-Meier survival curves and Cox regression) and mixed effects longitudinal analyses. Additionally, the investigators will employ propensity score matching and/or inverse probability of treatment weighting, to create balanced cohorts and reduce bias.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with sle - systemic lupus erythematosus. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

University Hospital 'Attikon'

Athens, Attica, Greece

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NCT07056621


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