l UK launch date:
Comments
Mar 15: status uncertain - NCT01870284 was withdrawn due to ´unexpected operational issues outside of Lilly´s control´ and no further trials are in progress; it is no longer listed on Lilly´s pipeline [3,4].
25/03/2015 17:19:04
Oct 13: Remains PIII [2].
10/03/2014 10:45:01
Trial or other data
Jun 13: NCT01870284 (SPIRIT A1) is a multicentre, randomized, double-blind, active (adalimumab) and placebo-controlled 16-week study followed by long term eva luation of efficacy and safety of ixekizumab in 408 patients with active ankylosing spondylitis. Inclusion criteria include: diagnosis of moderate to severe AS with prior documented Xray evidence fulfilling the Modified New York criteria for AS (1984); active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and the spinal pain score ≥4 on a numeric rating scale; inadequate response to NSAIDs. The primary outcome is assessment of SpondyloArthritis International Society Criteria (ASAS20). The study starts Aug 13 and is due to complete Dec 17 (primary outcome data collection Oct 15) [1].
10/06/2013 13:51:44
References
Available only to registered users
Category
BNF Category: Drugs that suppress the rheumatic disease process (10.01.03)
Pharmacology: Humanized anti–interleukin-17 monoclonal antibody
Epidemiology: Annual incidence of AS is ~ 6.9 per 100,000 population, with around 2,300 new cases each year in England and Wales (NICE TA143. May 2008). Around 71,000 people in England are estimated to have AS (NICE Costing statement: Golimumab for the treatment of AS. August 2011).
Indication: Ankylosing spondylitis (AS)
Method(s) of Administration
Subcutaneous
Company Information
Name: Eli Lilly
US Name: Eli Lilly
Further Information
Anticipated commissioning route (England) CCG
High cost drug list? Yes
Implications Available only to registered users |
