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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)
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01118728
First received: May 5, 2010
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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: Endpoint Classification: Safety Study
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:

U.S. FDA Resources

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) ] [ Designated as safety issue: Yes ]

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) ] [ Designated as safety issue: No ]

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118728

Locations
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
Austria
Sanofi-Aventis Administrative Office
Wien, Austria
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
France
Sanofi-Aventis Administrative Office
Paris, France
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Lithuania
Sanofi-Aventis Administrative Office
Vilnius, Lithuania
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01118728     History of Changes
Other Study ID Numbers: LTS11298, 2010-019263-11
Study First Received: May 5, 2010
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
 Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on May 23, 2013