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

• ClinicalTrials.gov Identifier: NCT01118728
• Recruitment Status: Terminated
• First Posted: May 7, 2010
• Results First Posted: June 21, 2017
• Last Update Posted: June 21, 2017
• Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Information provided by (Responsible Party): Sanofi

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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).

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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

Czechia

Sanofi-Aventis Administrative Office

Praha, Czechia

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

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01118728
• Other Study ID Numbers: LTS11298; 2010-019263-11 ( EudraCT Number )
• First Posted: May 7, 2010
• Results First Posted: June 21, 2017
• Last Update Posted: June 21, 2017
• Last Verified: May 2017

Additional relevant MeSH terms:

Spondylitis; Spondylitis, Ankylosing; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylarthropathies; Spondylarthritis; Ankylosis; Joint Diseases; Arthritis