Efficacy and safety of secukinumab in pts with Psoriatic Arthritis
Research type
Research Study
Full title
A phase III randomised, double-blind, placebo-controlled multicentre study of subcutaneous secukinumab in autoinjectors, to demonstrate the efficacy at 24 weeks and to assess the long term safety, tolerability and efficacy up to 3 years in subjects with Active Psoriatic Arthritis.
IRAS ID
144254
Contact name
Bruce Kirkham
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2013-004002-25
ISRCTN Number
NA
Clinicaltrials.gov Identifier
NA
Research summary
Psoriatic arthritis (PsA) is a chronic inflammatory disease involving an over-active immune system that develops in at least 5% of patients with the skin condition psoriasis. The disease can cause painful inflammation in many different joints of the body including the hands, wrists, feet and larger joints as well as the lower spine and pelvis. It can also cause swelling and pain in fingers (dactylitis) and tendons (enthesitis). It has a strong genetic link.
Treatment of the disease aims to reduce pain and inflammation. Recently biologic drugs have proven successful at treating PsA. Biologics are protein based drugs which can target particular elements of the over-active immune system. The most commonly used biologic treatments for PsA are drugs which block a particular chemical messenger called TNF-alpha.
Secukinumab is a new class of biologic which blocks the activity of one of the chemical messengers which is involved in the immune system and is implicated in psoriatic arthritis. This study aims to look at the efficacy at 24 weeks and to assess the long term safety, tolerability and efficacy of subcutaneous secukinumab in autoinjectors over 3 years in patients with active Psoriatic Arthritis.
Eligible patients will be randomly allocated to one of 3 treatment groups (1:1:1) - Group 1: secukinumab 150mg sc, Group 2: secukinumab 300mg sc, Group 3: placebo. Study treatment will be administered at baseline, weeks 1, 2, 3 and 4 followed by dosing every 4 weeks for up to 3 years.
Neither the patients nor the doctors will know which treatment they receive. PsA will be assessed throughout the three year treatment period, along with a range of safety measures. The study will recruit approximately 405 patients worldwide with 50 of these from 10 sites in the UK.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
14/EM/0024
Date of REC Opinion
21 Jan 2014
REC opinion
Favourable Opinion