MAXIMISE
Research type
Research Study
Full title
MAXIMISE (Managing AXIal Manifestations in Psoriatic Arthritis with SEcukinumab), a randomized, double-blind, placebo-controlled, multicenter, 52 week study to assess the efficacy and safety of secukinumab 150 mg or 300 mg s.c. in patients with active psoriatic arthritis and axial skeleton involvement who have inadequate response to non steroidal anti-inflammatory drugs (NSAIDs)
IRAS ID
205699
Contact name
Hasan Tahir
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2016-000814-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 26 days
Research summary
Psoriatic arthritis (PsA) is a chronic inflammatory disease involving an over active immune 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 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 PsA. This study aims to look at the options for patients in managing the axial manifestations (joint involvement)with two different doses of Secukinumab, 150mg and 300mg over a 1 year period. It also aims to provide further safety and efficacy data for Secukinumab using prefilled syringes in patients with PsA.
The study will be split into two treatment periods. Eligible patients will be randomly allocated to on of the 3 treatment groups 1:1:1 ratio.
Group 1: Secukinumab 150mg + Placebo 150mg
Group 2: Secukinumab 300mg
Group 3: Placebo 300mg (those allocated to group 3, will be re-allocated to either group 1 or 2 at week 12.
Study treatment will be administered at baseline, weeks 1, 2, 3 and 4 followed by dosing every 4 weeks for up to 1 year.
Neither the patients nor the doctors will know which treatment is received until they have completed week 52. This study will recruit approx.495 patients with 50 patients being recruited in the UK, from 10 sites.REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0332
Date of REC Opinion
28 Sep 2016
REC opinion
Further Information Favourable Opinion