Ustekinumab in Subjects With Nonradiographic Axial Spondyloarthritis
Research type
Research Study
Full title
A Phase 3, Multicentre, Randomised, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis
IRAS ID
182750
Contact name
Aimee Carvell
Contact email
Eudract number
2015-000289-67
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 2 months, 7 days
Research summary
The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nr-AxSpA.
Axial spondyloarthritis is a chronic inflammatory disease, manifested by back pain and progressive stiffness of the spine, which affects mainly the spine and sacroiliac joints. The term Nonradiographic Axial Spondyloarthritis is an earlier stage of the disease, whereby no changes or damage in the bones is visible on x-ray.
For patients with this disease there is an unmet need for new therapies targeting pathways other than anti-tumour necrosis factor alpha (anti-TNFa), especially those with an improved benefit/risk profile.
Approximately 390 subjects globally will be randomised into one of three arms - ustekinumab 45mg, ustekinumab 90mg or placebo which will be administered at Weeks 0, 4 and 16. At Week 16 subjects on the placebo arm who demonstrate less than 10% improvement from baseline in both total back pain and morning stiffness at Weeks 12 and 16 will be re-randomised to receive the active drug either 45mg or 90mg dose at Week 16, 20, and 28 and then 12 weekly until Week 52. At Week 24 all patients remaining on the placebo arm will be re-randomised to receive active drug 45mg or 90mg dose, at Weeks 24 and 28 and then 12 weekly until Week 52. At Week 52, subjects with inactive disease will be re-randmomised to remain on ustekinumab or switch to placebo, those with who do not achieve that will remain on active drug through until Week 88. The end of study visit to review final safety and efficiacy will take place 12 weeks after last study drug administration at Week 100.
Subjects will be on the study for a mximum of 108 weeks.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
15/SW/0220
Date of REC Opinion
13 Oct 2015
REC opinion
Further Information Favourable Opinion