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

Recruiting now

Conditions studied: SLE - Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT07056621

Run by

Biomedical Research Foundation, Academy of Athens

People needed

684

Starts

2025-06-30

Expected to finish

2026-06-01

Last updated by the study team

2025-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients with incomplete medical records or missing key variables
• Patients with concomitant autoimmune disorders (excluding thyroid disease)

Where it is running

• University Hospital 'Attikon' — Athens, Attica, Greece (enrolling)

Full record on ClinicalTrials.gov

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