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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Greece
University Hospital 'Attikon'
RECRUITING
Athens
Contact Information
Primary
Dimitrios T. Boumpas, Professor in Medicine
boumpasd@uoc.gr
00306937212025
Backup
Antonis Fanouriakis, Ass. Professor in Medicine
afanour@med.uoa.gr
00306973016540
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2026-06
Participants
Target number of participants: 684
Treatments
Group A: Belimumab
Group A will consist of patients under treatment with belimumab.
Group B: Standard-of-care (follow-up after May 1st 2014)
Group B will consist of patients on standar-of-care SLE treatment, who were followed-up after May 1st 2014 (the first date where belimumab was available in Greece).
Group C: Standar-of-care (follow-up before May 1st 2014)
Group C will consist of a historical cohort of patients under standar-of-care, followed-up before May 1st 2014 (the first date where belimumab was available in Greece).
Related Therapeutic Areas
Sponsors
Leads: Biomedical Research Foundation, Academy of Athens

This content was sourced from clinicaltrials.gov

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