Secukinumab - efficacy and safety in Ankylosing Spondylitis

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled , multicentre, study of secukinumab to demontrate the efficacy at 16 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active Ankylosing Spondylitis.

• IRAS ID

  79761

• Contact name

  Novartis UK

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-024529-18

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Ankylosing spondylitis (AS) is a chronic inflammatory disease involving an overactive immune system. The disease typically causes painful inflammation in the bones and joints of the lower spine and pelvis, but sometimes also more peripheral joints as well. It has a strong genetic link. Treatment of the disease aims to reduce pain and inflammation. Recently biologic drugs have proven successful at treating AS. Biologics are protein based drugs which can target particular elements of the over-active immune system. The most commonly used biologic treatments for AS are drugs which block a particular chemical messenger called TNF-alpha. This study aims to look at the efficacy and safety of secukinumab in patients with active Ankylosing Spondylitis over a 2 year period. Eligible patients will be randomly allocated to receive secukinumab or placebo, but neither the patients nor the doctors will know which they are receiving. Patients will be assessed after 16 and 24 weeks of treatment and their treatment may be changed if they are not responding to the treatment but again neither the patient northe doctor will know what treatment the patient is receiving. AS will be assessed throughout the two year treatment period, along with a range of safety measures. The study is looking to recruit approximately 350 patients worldwide into the study with 20 of these from 5 centres in the UK.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0220

• Date of REC Opinion

  2 Aug 2011

• REC opinion

  Further Information Favourable Opinion