Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
Primary objective:
- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS)
using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20)
Secondary objectives:
- to demonstrate that Sarilumab was effective on:
- assessment of higher level of response [ASAS 40% response criteria (ASAS40)]
- partial remission
- disease activity
- range of motion
- Magnetic Resonance Imaging (MRI) of the spine
- to assess the safety and tolerability of Sarilumab in participants with AS as well as
the pharmacokinetic profile of Sarilumab in participants with AS