Secukinumab in Ankylosing Spondylitis
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis
IRAS ID
146639
Contact name
Hasan Tahir
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2013-001090-24
Clinicaltrials.gov Identifier
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 overactive immune system. The most commonly used biologic treatments for AS are drugs which block a particular chemical messenger called TNF-alpha.
The purpose of this study is to look at the safety and efficacy of secukinumab delivered in liquid in vial (LiV) and pre-filled syringe (PFS) formulations, in patients with active Ankylosing Spondylitis after 16 weeks of treatment. Patients who take part in the study will be randomly allocated to receive secukinumab or placebo for the first 16 weeks of the study. After 16 weeks, all patients will receive active treatment. Study participants will receive treatment for up to 3 years to assess the long-term efficacy, safety, and tolerability of the treatment. Patients with active AS will be treated despite current or previous NSAID, DMARD, and/or anti-TNF-alpha therapy.
The study is looking to recruit approximately 222 patients worldwide into the study with 10 of these from 3 centres in the UK.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
14/EM/0086
Date of REC Opinion
26 Mar 2014
REC opinion
Further Information Favourable Opinion