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Collects real-life data on belimumab use in adults with lupus in Spain

Records outcomes of belimumab treatment in adults with active lupus across Spain.

Plain-language title generated from the registry record
Registry title: Belimumab in Patients With Systemic Lupus Erythematosus

Key facts

Where
Barcelona, SpainSee the site

Where in Spain

  • Hospital Clinic BarcelonaBarcelona, SpainNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Grupo de Trabajo de Enfermedades Autoinmunes Sistémicas (GEAS) de la Fundación Española de Medicina
Trial code
NCT04671706
Record updated
17 December 2020
Original description
The BeliLES-GEAS project pretends to obtain an extensive data registry of patients with systemic lupus erythematosus (SLE).Read full original descriptionShow less

Effectiveness, Tolerability, and Safety of Belimumab in Patients With Systemic Lupus Erythematosus Treated at the Spanish Departments of Internal Medicine

The BeliLES-GEAS project pretends to obtain an extensive data registry of patients with systemic lupus erythematosus (SLE).

The main objective is to create a national SLE patients registry treated with belimumab to describe effectiveness and safety of intravenous (IV) or subcutaneous (SC) belimumab in patients with active SLE treated in the Spanish departments of Internal Medicine in a real-life setting. This research project aspires to cover the vast majority (if not the whole) of SLE patients treated with belimumab in all of the Spanish Departments of Internal Medicine.

Inclusion: 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; Age of 18 years or more; Having received at least one dose of intravenous or subcutaneous belimumab according the physician criteria regardless the clinical/immunological response; Signed informed consent.

Exclusion: Negative from the patient to participate in the study.

ClinicalTrials.gov NCT04671706