CAIN457F3301 (ACHILLES) Secukinumab in patients with PsA and axSpA
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab to demonstrate efficacy in the treatment of enthesitis at the Achilles tendon up to 1 year in adult patients with active Psoriatic Arthritis (PsA) and axial Spondyloarthritis (axSpA)(ACHILLES)
IRAS ID
207353
Contact name
Yusuf Patel
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2016-000972-91
Duration of Study in the UK
2 years, 7 months, 29 days
Research summary
PsA (Psoriatic Arthritis) and axSpA (axial Spondyloarthritis) are chronic inflammatory diseases involving an overactive immune system. The disease can cause painful inflammation and swelling in joints of the body, along with at the tendons (enthesitis). Achilles tendon enthesitis is mostly represented by pain and swelling at the heel.\n\nThis clinical research study aims to find out if the drug AIN457/Secukinumab is safe and has beneficial effects in people who have PsA or axSpA with active enthesitis including one achilles tendon site despite current or previous treatment with pain killers (non-steroidal anti-inflammatory drugs (NSAIDs)) and/or disease modifying anti-rheumatic drugs (DMARDs). \n\nTreatment of the disease aims to reduce pain and inflammation. Biologic drugs have proven a successful treatment. The most commonly used biologic treatments are drugs which block a chemical messenger, named TNFalpha. Secukinumab is a new class of biologic which blocks specifically the activity of one of the chemical messengers and will be administered to patients via pre-filled syringes.\n\nThis is a 52 week study, consisting of an 8 week screening period, 24 week placebo controlled double blind treatment period and a 28 week open label treatment period. The study is being conducted at sites across Europe, with a recruitment target of 200 patients, 20 of which being recruited from the UK.\n\nThe countries in Europe participating in this study are: Bulgaria, Czech, Germany, Greece, Italy, Slovakia, Spain and the UK.\n\n
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0506
Date of REC Opinion
24 Aug 2016
REC opinion
Further Information Favourable Opinion