A potential new treatment for nonradiographic axial spondyloarthritis
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled multicentre study of secukinumab to evaluate the safety, tolerability and efficacy up to 2 years in patients with active nonradiographic axial spondyloarthritis
IRAS ID
184873
Contact name
Nick Barkham
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-001106-33
Duration of Study in the UK
3 years, 6 months, 26 days
Research summary
Research Summary:
Axial Spondyloarthritis (axSpA) is a chronic inflammatory disease predominantly affecting the axial skeleton (sacroiliac joints and spine). The main symptoms are back pain and spinal inflammation. axSpA is among the most common chronic inflammatory joint disorders. Recently biologic drugs have proven effective at treating axSpA. Biologics are protein based drugs which can target particular elements of the overactive immune system. The most commonly used biologic treatments for axSpA 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 axSpA.
This study aims to compare the safety, effectiveness and tolerability of Secukinumab compared to placebo in the treatment of active non-radiographic axSpA (nr-axSpA). The study will provide up to 2 years of safety and efficacy data for Secukinumab using subcutaneous pre-filled syringes. Eligible patients will be randomly allocated to one of three treatment groups (2:1):
Group 1: Secukinumab 150mg sc with loading dose
Group 2: Secuminumab 150mg sc without loading dose
Group 3: Placebo
Study treatment will be administered at Baseline, Weeks 1,2 and 3 followed by every four weeks starting at Week 4. Neither the patients or the Study Doctors will know which treatment they receive at this stage. If patients in the placebo arm do not respond repeatedly, at week 20 they can switch to secukinumab 150mg.
At Week 52 all patients will receive open-label Secukinumab 150mg sc up to Week 100. This study will recruit approximately 555 patients with 50 patients being recruited in the UK, from up to 12 sites.Summary of Results:
: A patient summary of the trial results will be posted on:https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbdYVDsSZox2o7q1uVmguIbAxkAUsp5VF-2BHcAbUKGmAuaVGiQ_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJ3XEEAqfFtYedU0MT2I81bfXCHLy-2BfWGmtJX9wrwwVYm731EIASTBjb1YDlBc5w-2Fm3hkNXgZzhpVJh6aOigxCncQ56bXpJcRB-2Fow9HdDemaJ6gRQwq5MNfGHKPBmK7m6lTCdPbKv1VMQcMFyDhlGT2iCL-2B2Kc6CoazBvexlCOjew-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7Cb8413ade08624ae347e208d9b01d7bb6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637734462936534820%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=t%2FnFvsJqc6Jnbfcn9dCov9VoobqcSigBsuLGsBjSmPw%3D&reserved=0
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0133
Date of REC Opinion
5 Apr 2016
REC opinion
Further Information Favourable Opinion