At a glance
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An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis
In Brief
A Phase 3 clinical trial evaluating Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection. for Ankylosing Spondylitis. Completed, enrolled 30 participants across 10 sites.
Detailed Summary
The purpose of this study was to assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy and safety data were used to support the registration of secukinumab in Japan for the treatment of active AS.
Study Details
Timeline
Interventions
Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks.