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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Patients with incomplete medical records or missing key variables - Patients with concomitant autoimmune disorders (excluding thyroid disease) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * Patients with incomplete medical records or missing key variables * Patients with concomitant autoimmune disorders (excluding thyroid disease)

Locations (1)

University Hospital 'Attikon'
Athens, Attica, Greece