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

Sanofi

Status and phase: Terminated; Phase 2

Conditions: Ankylosing Spondylitis

Treatments: Drug: Sarilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01118728

LTS11298

2010-019263-11 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

223 participants in 1 patient group

Sarilumab

Experimental group

Description:

Sarilumab 150 mg subcutaneous (SC) injection every week (or every other week in case of safety issue) for 260 weeks, or until commercially available, or until discontinuation of the project, whichever came first.

Treatment:

Drug: Sarilumab