NCT01649375

16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

A Randomized, Double-blind, Placebo-controlled Phase III Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy at 16 Weeks and to Assess Long-term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor

Conditions

• Anklyosing Spondylitis

Interventions

Type	Name	Description
DRUG	Secukinumab (75 mg)	Secukinumab 75 mg s.c.
DRUG	Placebo	Placebo
DRUG	Secukinumab (150 mg)	Secukinumab 150 mg s.c.

Timeline

• Start date: 2012-10-18
• Primary completion: 2014-08-04
• Completion: 2018-09-18
• First posted: 2012-07-25
• Last updated: 2019-10-30
• Results posted: 2019-10-30

Locations

53 sites across 13 countries: United States, Austria, Canada, Czechia, Finland, Germany, Italy, Netherlands, Russia, Singapore, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study