Belimumab in Patients With Systemic Lupus Erythematosus

Launched by GRUPO DE TRABAJO DE ENFERMEDADES AUTOINMUNES SISTÉMICAS (GEAS) DE LA FUNDACIÓN ESPAÑOLA DE MEDICINA · Dec 11, 2020

Keywords

ClinConnect Summary

The BeliLES-GEAS trial is studying how effective and safe a medication called belimumab is for patients with systemic lupus erythematosus (SLE), a condition that can cause inflammation and affect various parts of the body. The goal of this research is to create a comprehensive registry of SLE patients in Spain who are receiving belimumab, either through an injection into a vein (intravenous) or under the skin (subcutaneous). This will help doctors understand how the medication works in real-life situations, outside of controlled clinical settings.

To participate in this trial, individuals need to be at least 18 years old and have a confirmed diagnosis of SLE based on specific medical criteria. They should have received at least one dose of belimumab, regardless of how well it worked for them. Participants will need to provide informed consent, meaning they agree to be part of the study after understanding what it involves. The study is not yet recruiting participants, but it aims to include a wide range of patients with SLE throughout Spain to gather valuable data on this treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Fulfillment of the 2019 EULAR/ACR classification criteria for SLE, SLICC classification criteria, 1997 American College of Rheumatology (ACR) revised criteria for SLE or patients with only 3 criteria but SLE diagnosed according to the clinical judgment of the treating physician.
• • 2. Age of 18 years or more.
• • 3. Having received at least one dose of intravenous or subcutaneous belimumab according the physician criteria regardless the clinical/immunological response.
• • 4. Signed informed consent.
• Exclusion Criteria:
• • 1) Negative from the patient to participate in the study.