At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)
In Brief
A Phase 2 clinical trial evaluating Sarilumab and Placebo for Ankylosing Spondylitis. Completed, enrolled 301 participants across 80 sites in 14 countries.
Detailed 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
Study Details
Timeline
Interventions
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous