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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01118728
Recruitment Status : Terminated (Lack of benefit on efficacy)
First Posted : May 7, 2010
Results First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Regeneron Pharmaceuticals
Information provided by (Responsible Party):

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Sarilumab Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : June 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Sarilumab

Arm Intervention/treatment
Experimental: Sarilumab
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.
Drug: Sarilumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR153191
  • REGN88

Primary Outcome Measures :
  1. Percentage of Participants Experiencing Any Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Treatment Discontinuation [ Time Frame: Baseline up to the end of study (66 weeks) ]
    An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, regardless of the relationship to the investigational medicinal product (IMP). SAE was any untoward medical occurrence that at any dose resulted in death or was life-threatening or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect or was a medically important event. TEAEs were AEs that developed or worsened or became serious during the TEAE period (time from first dose of IMP up to the end of follow-up period).

Secondary Outcome Measures :
  1. Percentage of Participants Who Achieved 20% Response in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) [ Time Frame: Baseline up to the end of treatment (60 weeks) ]
    Treatment response for ASAS20 was defined as: Improvement of ≥ 20% and ≥ 1 unit on a 0 (least) to 10 (worst) numerical rating score (NRS) in at least 3 of the 4 ASAS improvement criteria (ASASIC) domains, and no worsening of ≥ 20% and ≥ 1 unit on 0-10 NRS in the remaining domain. The 4 domains included were participant's global disease activity assessment, total back pain, physical function (Bath Ankylosing Spondylitis Functional Index), and Inflammation (mean of last 2 Bath Ankylosing Spondylitis Disease Activity Index questions on morning stiffness).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118728

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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
Sanofi-Aventis Administrative Office
Praha, Czechia
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
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01118728    
Other Study ID Numbers: LTS11298
2010-019263-11 ( EudraCT Number )
First Posted: May 7, 2010    Key Record Dates
Results First Posted: June 21, 2017
Last Update Posted: June 21, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Axial Spondyloarthritis