Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study
Biomedical Research Foundation, Academy of Athens
684 participants
Jun 30, 2025
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
Inclusion Criteria5
- Systemic lupus erythematosus classification according to the Systemic Lupus International Collaborating Clinics (SLICC) criteria
- Age ≥ 18 years old
- Time of follow-up ≥ 6 months
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥ 4
- Physician Global Assessment (PGA) visual analogue score \> 1
Exclusion Criteria2
- Patients with incomplete medical records or missing key variables
- Patients with concomitant autoimmune disorders (excluding thyroid disease)
Interested in this trial?
Get notified about updates and connect with the research team.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07056621