M16-098 - Upadacitinib in patients with Ankylosing Spondylitis.
Research type
Research Study
Full title
A Multicentre, double-blind, parallel-group, placebo controlled study evaluating the safety and efficacy of Upadacitinib in subjects with active Ankylosing Spondylitis. Incorporating Protocol Amendment 0.01 (VHP Countries)and Amendment 1
IRAS ID
230642
Contact name
Dr Karl Gaffney
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2017-000431-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 6 days
Research summary
Ankylosing Spondylitis (AS) is a form of chronic arthritis causing inflammation in the spine. This can cause pain and stiffness in the back. The spine may become fused which may cause curvature and stiffness. It is a disease which can result in inflammation of the eyes, skin and bowels. Patients’ usual first line of treatment is with Non-Steroidal Anti -Inflammatory Drugs (NSAIDS) to reduce pain and inflammation. If these are not effective, a biologic medication such as an anti Tumor Necrosis Factor (TNF) inhibitor or Interleukin (IL) 17 inhibitor is given. These can only achieve an adequate response in up to 50% of patients and treatment options are often limited for this disease. This study intends to find out if a new oral medication (Upadacitinib) is safe and effective in treating 170 AS patients compared to placebo. As other organs of the body can be affected, these will also be monitored throughout the study. Patients will undergo a screening process up to a maximum of 35 days to confirm the diagnosis and the extent of AS. Patients will then be randomly placed onto treatment for 14 weeks (period 1) to either placebo, or Dose A of Upadacitinib in a blinded fashion (no one will know what treatment the patient is getting). At Week 14, patients will be given open label dose A for an additional 90 weeks. The patients will have a final clinic visit 30 days after the last dose of the oral study drug to follow-up on any new or ongoing side effects.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0422
Date of REC Opinion
28 Dec 2017
REC opinion
Further Information Favourable Opinion