FUTURE 5
Research type
Research Study
Full title
A phase III, randomized, double-blind, placebo controlled multi-center study of subcutaenous secukinumab (150 mg and 300 mg) in prefilled syringe to demonstrate efficacy (including inhibition of structural damage), safety and tolerability up to 2 years in subjects with active psoriatic arthritis.
IRAS ID
173723
Contact name
Hector Chinoy
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-000050-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 8 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 prefilled syringes in patients with PsA.
Eligible patients will be randomly allocated to one of 4 treatment groups in a 2:2:2:3 ratio.
Group 1: secukinumab 150mg sc without loading dose,
Group 2: secukinumab 150mg sc with loading dose,
Group 3: secukinumab 300mg sc with loadng regimen.
Group 4:placebo. The placebo group is split into two treatment arms based on the active treatment the subject will receive at week 16/24.
Study treatment will be administered at baseline, weeks 1, 2, 3and 4 followed by dosing every 4 weeks for upto 2 years. Neither the patients nor the doctors will know which treatment they receive until they have completed week 52. This study will recruit approx. 990 patients with 100 patients being recruited in the UK, from 20 sites.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0668
Date of REC Opinion
6 Oct 2015
REC opinion
Further Information Favourable Opinion