Extrait

Background and study aims Systemic lupus erythematosus (SLE) is a long-term (chronic) disease which causes widespread inflammation (swelling) in the body. SLE occurs when the immune system attacks the body’s own cells (autoimmune disease). A person’s genes alongside other factors such as diet have been connected with the development and progression of the disease. B cell depletion therapy (normally rituximab) is used as part of standard of care in patients where their lupus is active. B cell depletion therapy removes a type of immune cell called B cells from the body. B cells can cause disease in lupus patients. Although patients respond to B cell depletion therapy the disease can quickly return. This is likely to be because a chemical (also known as a stimulating factor) called BAFF increases in the body once treatment ends, and switches the lupus back on. Belimumab is a drug that stops BAFF from working and has been shown to work in patients with lupus. The aim of this study is to investigate the safety and effectiveness of Belimumab in treating SLE. Who can participate? Men and women aged between 18-75 years old with systemic lupus erythematosus (SLE). What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group receive Belimumab through a drip at two week intervals for the first three doses and then at four week intervals until 52 weeks. Those in the second group receive normal saline (salt water) through a drip according to the same schedule. After 52 weeks, participants in both groups provide blood samples and complete questionnaires in order to find out how effective the belimumab treatment is compared to the placebo (dummy) treatment. What are the possible benefits and risks of participating? The benefits of participating include study patients having a regular review of their Lupus by an experienced Lupus specialist and information collected from this study will help improve the treatment of lupus. As Belimumab has not been given after drugs like rituximab in a research study it is not known if this is a safe combination. It is also possible that the risks of cancer, infections and effects on mood (feeling anxious or depressed) could be increased when both Belimumab and rituximab are administered close together. The most common side effects that happen during or soon after a belimumab dose are nausea, diarrhoea, and fever. Where is the study run from? University College London Hospital (lead centre) and 14 other NHS hospitals in England (UK) When is the study starting and how long is it expected to run for? January 2014 to December 2019 Who is funding the study? 1. Arthritis Research UK (UK) 2. GlaxoSmithKline foundation (UK) 3. University College London Biomedical Research Centre (UK) Who is the main contact? 1. Ms Felecia Ikeji (public) [email protected] 2. Professor Michael Ehrenstein [email protected]

Critère d'inclusion

• Specialty: Musculoskeletal disorders, Primary sub-specialty: Other; UKCRC code/ Disease: Inflammatory and Immune System/ Certain disorders involving the immune mechanism

Liens

• isrctn