Actively Recruiting
Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study
Led by Biomedical Research Foundation, Academy of Athens · Updated on 2025-09-08
684
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Systemic lupus erythematosus classification according to the Systemic Lupus International Collaborating Clinics (SLICC) criteria
- Age �3e�3d 18 years old
- Time of follow-up �3e�3d 6 months
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) �3e�3d 4
- Physician Global Assessment (PGA) visual analogue score > 1
You will not qualify if you...
- Patients with incomplete medical records or missing key variables
- Patients with concomitant autoimmune disorders (excluding thyroid disease)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital 'Attikon'
Athens, Attica, Greece, 12462
Actively Recruiting
Research Team
D
Dimitrios T. Boumpas, Professor in Medicine
CONTACT
A
Antonis Fanouriakis, Ass. Professor in Medicine
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here