Belimumab Assessment of Safety in SLE

Completed · Phase 4 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

Key facts

Study ID

NCT01705977

Run by

GlaxoSmithKline

People needed

4019

Starts

2012-11-27

Expected to finish

2022-08-10

Last updated by the study team

2024-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• GSK Investigational Site — La Plata, Buenos Aires, Argentina
• GSK Investigational Site — Lanus, Buenos Aires, Argentina
• GSK Investigational Site — Mar del Plata, Buenos Aires, Argentina
• GSK Investigational Site — Zárate, Buenos Aires, Argentina
• GSK Investigational Site — Rosario, Santa Fe Province, Argentina
• GSK Investigational Site — Rosario, Santa Fe Province, Argentina
• GSK Investigational Site — Venado Tuerto, Santa Fe Province, Argentina
• GSK Investigational Site — San Miguel de Tucumán, Tucumán Province, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Córdoba, Argentina
• GSK Investigational Site — Mendoza, Argentina
• GSK Investigational Site — San Miguel de Tucumán, Argentina
• GSK Investigational Site — Garran, Australian Capital Territory, Australia
• GSK Investigational Site — Sydney, New South Wales, Australia
• GSK Investigational Site — Herston, Queensland, Australia
• GSK Investigational Site — Fitzroy, Victoria, Australia
• GSK Investigational Site — Cuiabá, Mato Grosso, Brazil
• GSK Investigational Site — Belo Horizonte, Minas Gerais, Brazil
• GSK Investigational Site — Juiz de Fora, Minas Gerais, Brazil
• GSK Investigational Site — Curitiba, Paraná, Brazil
• GSK Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil
• GSK Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil
• GSK Investigational Site — Itajaí, Santa Catarina, Brazil
• GSK Investigational Site — Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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