Ustekinumab in Subjects with Radiographic 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 Anti-TNFα Refractory Subjects With Active Radiographic Axial Spondyloarthritis
IRAS ID
199970
Contact name
Aimee Carvell
Contact email
Sponsor organisation
Janssen R&D
Eudract number
2015-000288-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 17 days
Research summary
The purpose of the study is to assess the efficacy and safety of ustekinumab in subjects with active radiographic axial spondyloarthritis (AxSpA), who have had an inadequate response to anti-tumour necrosis factor (anti-TNFa), as measured by the reduction in signs and symptoms of their radiographic axial spondyloarthritis.\n\nAxial spondyloarthritis is a chronic inflammatory condition that affects the joints of the spine, as evidenced by back pain and progressive stiffness of the spine. As part of the body’s reaction to inflammation, calcium is laid down where the ligaments attach to the bones that make up the spine (vertebrae), reducing the flexibility of the back and causing new bone to grow at the sides of the vertebrae which can lead to the spine fusing. The term radiographic axial spondyloarthritis refers to where the changes can be seen on x-ray.\n\nFor these patients there is an unmet need for new therapies targeting pathways other than antiTNFa, especially those with an improved benefit/risk profile.\n\n483 subjects will be enrolled globally. The study consists of 3 phases; Screening (up to 8 weeks), Treatment phase: placebo-controlled (Week 0 to 24) and active treatment (Week 24 to Week 52), and Safety Follow-up (Week 64). Participants will be randomly assigned to 1 of 3 treatment groups: placebo, ustekinumab 45 mg and ustekinumab 90 mg at Week 0, 4 and 16. At Week 16 subjects with less than 10% improvement from baseline in both total back pain and morning stiffness at Weeks 12 and 16 will crossover to golimumab 50mg 4 weekly doses until Week 52. Patients on ustekinumab arms will have 12 weekly dosing through until Week 52. Any patients remaining on placebo at Week 24 will be rerandomised to receive ustekinumab 45 mg or 90 mg through Week 52. \n\nThe total duration of study will be up to 72 weeks.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
16/SW/0090
Date of REC Opinion
21 Jun 2016
REC opinion
Further Information Favourable Opinion