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)

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

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.

Inclusion criteria:

• Participant with AS who participated and completed 12-week treatment in study DRI11073-NCT01061723.

Exclusion criteria:

• Adverse event(s) having lead to treatment discontinuation in the DRI11073 study;
• Event or laboratory abnormality observed at the last treatment visit of DRI11073 study that would have adversely affected participation of the participant in this study as per investigator judgment.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.