Effects of B cell depletion on bone turnover in rheumatoid arthritis.

• Research type

  Research Study

• Full title

  Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody. An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial.

• IRAS ID

  57033

• Contact name

  Jacob van Laar

• Sponsor organisation

  South Tees Hospitals NHS Trust

• Eudract number

  2010-020499-50

• ISRCTN Number

  ISRCTN82317088

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Rituximab (product name 'MabThera') is a new B cell depleting antibody’s for the treatment of rheumatoid arthritis. It suppresses disease activity but may also have beneficial effects on bone. Increased bone turnover is a common problem in rheumatoid arthritis which can lead to severely reduced bone density (“osteoporosis”) and fractures of bones. Some drugs used in the treatment of rheumatoid arthritis also accelerate bone breakdown, e.g. prednisolone, while other drugs are effective in counteracting this. The main purpose of this study is to investigate whether rituximab protects bone. To this end we will measure markers of bone turnover in blood and measure bone density of the spine, forearms and hips with a so-called DEXA scanner before and one year after the first infusion of rituximab. We hope to demonstrate that rituximab attenuates bone turnover and maintains bone density.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  10/H0906/57

• Date of REC Opinion

  5 Nov 2010

• REC opinion

  Further Information Favourable Opinion