NA22823 -Phase II/III study of TCZ v placebo in Ankylosing Spondylitis

• Research type

  Research Study

• Full title

  A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy.

• IRAS ID

  59007

• Contact name

  Jon Packham

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2009-017443-34

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Study NA22823 is a phase II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of 2 stage design. The purpose is to study the reduction in the signs and symptoms and of the inhibition of structural damage during treatment with the investigational medicinal product, tocilizumab (TCZ), versus placebo in patients with ankylosing spondylitis who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) and who are naive to TNF (Tumor Necrosis Factor) antagonist therapy.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/64

• Date of REC Opinion

  1 Nov 2010

• REC opinion

  Further Information Favourable Opinion