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

NCT07056621 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 684

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

  • SLE - Systemic Lupus Erythematosus

Sponsors & Collaborators

  • Biomedical Research Foundation, Academy of Athens

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07056621 on ClinicalTrials.gov