Studies whether belimumab changes how lupus progresses over time
Compares lupus progression in adults given belimumab with those on standard care.
Plain-language title generated from the registry record
Registry title: Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study
Key facts
- Where
- Athens, GreeceSee the site
Where in Greece
- University Hospital 'Attikon'Athens, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biomedical Research Foundation, Academy of Athens
- Trial code
- NCT07056621
- Record updated
- 8 September 2025
- Original description
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).Read full original descriptionShow less
Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study
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.
Inclusion: 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: Patients with concomitant autoimmune disorders (excluding thyroid disease); Patients with incomplete medical records or missing key variables.