EMBODY 4

• Research type

  Research Study

• Full title

  A phase 3, multicenter, open-label, extension study to asssess the safety and tolerability of Epratuzumab treatment in systemic lupus erythematosus subjects (EMBODY 4)

• IRAS ID

  68990

• Sponsor organisation

  UCB Inc.

• Eudract number

  2010-020859-30

• ISRCTN Number

  N/A

• Research summary

  Systemic lupus erythematosus - often abbreviated to SLE or lupus - is a persistent or chronic systemic autoimmune disease (where the body's attacked by its own immune system). The disease can affect any part of the body, resulting in inflammation and tissue damage, but mostly affects the heart, joints, skin, lungs, blood vessels, liver, kidneys, and nervous system. The disease is unpredictable and has periods of active disease (known as flares) and remission. There is currently no cure.UCB Inc., is sponsoring a program of clinical trials using the new drug Epratuzumab. The drug is believed to work, in part, by changing how B-cells (a type of white blood cell that produces antibodies, which detect and destroy foreign substances in the body) work and/or by reducing their number in the body, which may prevent the immune system from attacking healthy organs and thus reduce the level of inflammation. It is hoped that epratuzumab may provide a specific treatment of the signs and symptoms of SLE across many of the body systems affected by the disease. This study will look at the long-term safety, tolerability and effectiveness of epratuzumab. 1250 participants who have completed a previous study with epratuzumab will be in the study for up to 100 weeks. During this time, they will undergo the following:?½ Open-Label Treatment Period: 600mg of epratuzumab for a total of 4 consecutive weeks per 12-week treatment cycle . There will be eight 12-week treatment cycles over 96 weeks (about 2 years)?½ Safety Follow-Up Visit: 13 weeks from the final dose of epratuzumab, or a maximum of 4 weeks beyond Week 96A variety of blood tests, study doctor assessments and participant completed questionnaires will be used to measure the long-term safety, tolerability and effectiveness of epratuzumab.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  11/WM/0050

• Date of REC Opinion

  17 May 2011

• REC opinion

  Further Information Favourable Opinion