NCT01118728

Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

A Multicenter Uncontrolled Extension Study Evaluating the Long Term Safety and Efficacy of SAR153191 in Patients With Ankylosing Spondylitis (AS)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: * To assess the long term safety of Sarilumab (SAR153191/REGN88) in participants with ankylosing spondylitis (AS) Secondary Objective: * To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in participants with AS

Detailed description

The maximum study duration per participant was to be 267 weeks (approximately 5 years) broken down as follows: * screening up to a maximum of 1 week; * treatment up to a maximum of 260 weeks; * follow-up of 6 weeks after treatment discontinuation.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Sarilumab	Pharmaceutical form: solution for injection Route of administration: subcutaneous

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-05-07
• Last updated: 2017-06-21
• Results posted: 2017-06-21

Locations

12 sites across 12 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Hungary, Lithuania, Netherlands, Poland, Spain