Novartis ph3: Secukinumab response in Psoriatic Arthritis using PDUS
Research type
Research Study
Full title
A 52-week, multicenter study to assess the time course of response to secukinumab in joint inflammation using Power Doppler ultrasonography in patients with active psoriatic arthritis
IRAS ID
191323
Contact name
Paul Emery
Contact email
Sponsor organisation
Novartis Global Service Center Hyderabad
Eudract number
2015-002394-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 0 days
Research summary
Summary of Research
The reason for this study is to use an ultrasound imaging technology called Power Doppler Ultrasonography (PDUS) to evaluate how a new biological drug (secukinumab) affects inflammation of joints, ligaments and tendons compared to a placebo in people with Psoriatic Arthritis.The study will take place in approximately 57 centers in Canada, Europe and Latin America, with the aim of recruiting 218 patients.
The study drug, secukinumab, is a new type of medication for Psoriatic Arthritis called a human monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind to unique proteins that human bodies produce. Secukinumab binds and reduces the activity of a protein called interleukin-17A (IL-17A). Researchers believe that IL-17A causes symptoms of Psoriatic Arthritis. A product that targets IL-17A may help to relieve these symptoms and conditions.
Secukinumab is produced by the pharmaceutical company, Novartis Pharma AG, who sponsor this study.
Alongside secukinumab, Power Doppler Ultrasonography (PDUS) will be used to clinically evaluate how the drug is affecting the patient's joints.
There are three treatment periods in the study:
- Treatment Period 1, a 12-week treatment period where patients will receive either secukinumab and/or placebo;
- Treatment Period 2, a 12-week treatment period where patients will receive only secukinumab;
- Treatment Period 3, an optional 28-week extension period where patients will receive only secukinumab;
- There is also an optional sub-study involving additional tests of the skin, hands and feet during Treatment Period 1.The recruitment period for the study will be 18 months.
Summary of Results
ULTIMATE is the first randomized study that evaluated the effect of a biological DMARD: secukinumab on PDUS measured synovitis as the primary endpoint. It demonstrated that secukinumab rapidly and significantly decreased synovitis, indicating a direct effect of IL-17 inhibition on the synovium in patients with PsA. As synovitis is critical for cartilage and bone destruction in PsA, these data also provide the basis for the observed protection of joint structure by secukinumab in patients with PsA.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0132
Date of REC Opinion
11 May 2016
REC opinion
Further Information Favourable Opinion