Secukinumab - efficacy and long term safety in Ankylosing Spondylitis
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled phase III multicentre study of subcutaneous secukinumab in prefilled syringes to demontrate the efficacy at 16 weeks and to assess the long term efficacy, safety and tolerability up to 5 years in patients with active Ankylosing Spondylitis.
IRAS ID
106822
Contact name
Hasan Tahir
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2012-000046-35
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 5 year period. Eligible patients will be randomly allocated to receive secukinumab or placebo for 16 weeks and thereafter all patients will receive active treatment for 5 years. Neither the patients nor the doctors will know which treatment they receive. AS will be assessed throughout the five year treatment period, along with a range of safety measures. The study is looking to recruit approximately 222 patients worldwide into the study with 20 of these from 5 centres in the UK.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
12/EM/0309
Date of REC Opinion
17 Sep 2012
REC opinion
Favourable Opinion