WA22908 -Phase III study of TCZ v placebo in Ankylosing Spondylitis

• Research type

  Research Study

• Full title

  A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy

• IRAS ID

  59011

• Contact name

  Jon Packham

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2009-017488-40

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Study WA22908 is a phase III, 3-arm double-blind, randomized, parallel-group, placebo-controlled study. The purpose is to study the safety and reduction of signs and symptoms during treatment with the investigational medicinal product, tocilizumab (TCZ), versus placebo in patients with ankylosing spondylitis who have had an inadequate response to one or more of the anti-TNF agents infliximab, etanercept, adalimumab and golimumab.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/63

• Date of REC Opinion

  1 Nov 2010

• REC opinion

  Further Information Favourable Opinion