A randomized, double-blind, placebo-controlled multicenter study of secukinumab to evaluate the safety, tolerability and efficacy up to 2 years in patients with active non-radiographic axial spondyloarthritis
ID Number 16-1625Principal Investigator(s)
Department(s) or Division(s)
If subjects agree to join in this study, they may get either secukinumab 150 mg or a placebo for the first 52 weeks of the study. At the start of the trial, there is a 2 to 1 chance of receiving either secukinumab or placebo with no medicine. After 20 weeks, their disease status will be assessed jointly by their doctor and themselves, and if it appears that they have not improved repeatedly and have been on placebo, they can switch to secukinumab 150 mg.. After 52 weeks, all patients who remained on study treatment will receive secukinumab 150 mg until the end of the treatment period of 100 weeks.
Subjects participation will last for two years (or 112 weeks, which includes the 8-week follow-up period plus an additional 4-10 weeks screening period) Participation will consist of 33 visits (24 visits at the study center and 9 home administration visits).
Recruiting Patients: Yes