An extension study of Ixekizumab in Ankylosing Spondylitis (RHBY).
Research type
Research Study
Full title
Protocol I1F-MC-RHBY. A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients with Axial Spondyloarthritis.
IRAS ID
215678
Contact name
Benjamin Suggitt
Contact email
Sponsor organisation
Eli Lilly and Company Limited
Eudract number
2016-002634-69
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
Axial spondyloarthritis (axSpA) is a long-term inflammatory disease mainly affecting the sacroiliac joints and spine. It has two sub-groups; rad-axSpA and non-rad-axSpA. In Rad-axSpA (also known as ankylosing spondylitis) damage can be seen on an X-ray and in non-rad-axSpA it cannot.\n\nAxSpA affects up to 1.4% of the adult population worldwide. The exact cause is unknown but there may be a genetic link. About 80-95% of patients with rad-axSpA test positive for the HLA-B27 cell surface antigen.\n\nCurrent standard of care includes regular exercise, physical therapy, non-steroidal anti-inflammatory drugs (NSAIDs), and tumour necrosis factor (TNF) inhibitors. NSAIDs are the most common treatment. Many patients do not respond well or are not able to tolerate NSAIDs or TNF inhibitors. There remains a need for safer more effective treatments. \n\nThe cytokine IL17 (protein found in the blood) has been identified as playing a role in inflammation response and the progression of axSpA. Ixekizumab is a humanised monoclonal antibody designed to inhibit IL17, so reducing inflammation. It may, therefore be an alternative treatment to TNF inhibitor therapy in patients with axSpA.\n\nThe purpose of this study is to evaluate whether patients who took part in the first study (I1F-MC-RHBW ) remain free from flare ups after stopping treatment (weeks 24-64), to determine the time-point at which any flare ups happen after stopping treatment, to evaluate long-term effectiveness and safety of ixekizumab, and to evaluate progression of axSpA bone disease after two years of Ixekizumab treatment by looking at X-rays.\n\nEligible patients must have completed the first study, 18 years or older, diagnosed with rad-axSpA.\n\nSix NHS sites will take part in the study. Patients will take part for 2.5 years and have assessments including; physical examinations, questionnaires, spine X-rays, magnetic resonance imaging scan (MRI) of the spine, electrocardiograms (ECG’s), blood and urine tests.\n
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0060
Date of REC Opinion
18 Apr 2017
REC opinion
Further Information Favourable Opinion