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

This study has been terminated.
(Lack of benefit on efficacy)
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi Identifier:
First received: May 5, 2010
Last updated: January 11, 2013
Last verified: January 2013

Primary Objective:

  • To assess the long term safety of Sarilumab (SAR153191/REGN88) in patients with ankylosing spondylitis (AS)

Secondary Objective:

  • To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in patients with AS

Condition Intervention Phase
Ankylosing Spondylitis
Drug: Sarilumab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Uncontrolled Extension Study Evaluating the Long Term Safety and Efficacy of SAR153191 in Patients With Ankylosing Spondylitis (AS)

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overview of Adverse events [ Time Frame: from study drug intake up to the end of study participation (266 weeks max) ]

Secondary Outcome Measures:
  • Percentage of participants who achieve a 20% response according to the Assessment in AS Working Group Criteria for response [ASAS20] [ Time Frame: up to the end of treatment (260 weeks max) ]

Enrollment: 223
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sarilumab extension
Single injection of 2 mL of Sarilumab 75 mg/mL every week (or every other week in case of safety issue) for 260 weeks
Drug: Sarilumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR153191
  • REGN88

Detailed Description:

The maximum study duration per participant was to be 267 weeks (approximatively 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Patient 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 patient in this study as per investigator judgment.

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01118728

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Australia, New South Wales
Sanofi-Aventis Administrative Office
Macquarie Park, New South Wales, Australia
Sanofi-Aventis Administrative Office
Wien, Austria
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Laval, Canada
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Budapest, Hungary
Sanofi-Aventis Administrative Office
Vilnius, Lithuania
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sanofi-Aventis Administrative Office
Warszawa, Poland
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT01118728     History of Changes
Other Study ID Numbers: LTS11298
2010-019263-11 ( EudraCT Number )
Study First Received: May 5, 2010
Last Updated: January 11, 2013

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Arthritis processed this record on April 26, 2017