FUTURE 4
Research type
Research Study
Full title
A phase III, randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab (150 mg) in pre-filled syringe, with or without loading regimen, to demonstrate efficacy, safety and tolerability up to 2 years in patients with active psoriatic arthritis (FUTURE 4)
IRAS ID
170535
Contact name
Joanne Brown
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2014-003849-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 16 days
Research summary
Psoriatic arthritis (PsA) is a chronic inflammatory disease involving an over activeimmune system. 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 overactive immune system. The most commonly used biologic treatments for PsA are drugs which block a particular chemical messenger called TNFalpha.
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 PsA.
This studies aim is to look at the options for patients and if a loading dose is needed to achieve a quick onset of effect compared to not loading in the treatment of PsA. The study will also provide upto 2 years of efficacy and safety data for Secukinumab using pre-filled syringes in patients with PsA.
Eligible patients will be randomly allocated to one of 3 treatment groups (1:1:1) Group
1: secukinumab 150mg sc without loading dose, Group 2: secukinumab 150mg sc with loading dose, Group 3: placebo. Study treatment will be administered at baseline, weeks 1, 2, 3and 4 followed by dosing every 4 weeks for up to 2 years. Neither the patients nor the doctors will know which treatment they receive until they have completed week 24, at this point all patients will be receiving 150mg sc every 4 weeks. This study will recruit approx. 318 patients with 30 patients being recruited in the UK, from 6 sites.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
15/YH/0108
Date of REC Opinion
17 Apr 2015
REC opinion
Further Information Favourable Opinion