BiP-001

• Research type

  Research Study

• Full title

  A First in Human, Double-Blind, Randomised, placebo controlled study to investigate the effects of Recombinant Human BiP in patients with rheumatoid arthritis

• IRAS ID

  90834

• Contact name

  Bruce Kirkham

• Eudract number

  2011-005831-19

• ISRCTN Number

  ISRCTN22288225

• Research summary

  The human protein, BiP, has been shown to have a potent calming effect on human cells during inflammation. In an animal model of arthritis, a single dose of BiP given either before or during arthritis will prevent, or treat arthritis, respectively. BiP appears to act by promoting the development of cells which can control other cells that cause chronic inflammation in the rheumatoid joint. Therefore, we propose to give a single dose of BiP, or placebo, to 4 groups of patients, each group receiving increasing amounts of BiP. The primary aim of this study is to check that BiP is safe for use in patients. There are 2 secondary aims: first to establish whether BiP reduces the signs and symptoms of rheumatoid arthritis and, second, whether it improves laboratory measures of disease.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/0012

• Date of REC Opinion

  6 Sep 2012

• REC opinion

  Further Information Favourable Opinion