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

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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
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Intervention Drug: Sarilumab
Enrollment 223

Recruitment Details The study was conducted at 56 centers in 12 countries. A total of 224 participants were screened between 01 June 2010 and 03 June 2011.
Pre-assignment Details Of 224 screened participants, 223 participants were enrolled and treated. One participant withdrew consent before randomization.
Arm/Group Title Sarilumab
Hide Arm/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.
Period Title: Overall Study
Started 223
Completed 0
Not Completed 223
Reason Not Completed
Adverse Event             17
Lack of Efficacy             27
Sponsor's decision to discontinue study             172
Withdrawal by Subject             3
Lost to Follow-up             4
Arm/Group Title Sarilumab
Hide Arm/Group Description Sarilumab 150 mg 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.
Overall Number of Baseline Participants 223
Hide Baseline Analysis Population Description
All enrolled participants who received at least one dose of the study treatment after signature of the informed consent.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 223 participants
41.6  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants
Female
63
  28.3%
Male
160
  71.7%
1.Primary Outcome
Title Percentage of Participants Experiencing Any Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Treatment Discontinuation
Hide Description 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).
Time Frame Baseline up to the end of study (66 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population defined as all participants who received at least one dose of the study treatment after signature of the informed consent.
Arm/Group Title Sarilumab
Hide Arm/Group Description:
Sarilumab 150 mg 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.
Overall Number of Participants Analyzed 223
Measure Type: Number
Unit of Measure: Percentage of participants
Any TEAE 67.3
Any treatment-emergent SAE 5.4
Any TEAE leading to treatment discontinuation 8.1
2.Secondary Outcome
Title Percentage of Participants Who Achieved 20% Response in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20)
Hide Description 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).
Time Frame Baseline up to the end of treatment (60 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population. Number of participants analyzed=participants with ASAS20 assessment at specified time-points. Here 'n' signifies number of participants with available data for specified time-point.
Arm/Group Title Sarilumab
Hide Arm/Group Description:
Sarilumab 150 mg 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.
Overall Number of Participants Analyzed 218
Measure Type: Number
Unit of Measure: Percentage of participants
Week 0 (n=218) 30.3
Week 12 (n=207) 40.1
Week 24 (n=150) 46.0
Week 36 (n=93) 41.9
Week 48 (n=37) 59.5
Week 60 (n=7) 57.1
Time Frame All AEs were collected from signature of the informed consent form up to the final visit (Day 414) regardless of seriousness or relationship to investigational product
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (time from first dose of IMP up to the end of follow-up period).
 
Arm/Group Title Sarilumab
Hide Arm/Group Description Sarilumab 150 mg 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.
All-Cause Mortality
Sarilumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sarilumab
Affected / at Risk (%)
Total   12/223 (5.38%) 
Gastrointestinal disorders   
Crohn's disease  1  1/223 (0.45%) 
Infections and infestations   
Cellulitis  1  1/223 (0.45%) 
Diverticulitis  1  1/223 (0.45%) 
Gastroenteritis  1  1/223 (0.45%) 
Laryngitis  1  1/223 (0.45%) 
Investigations   
Tuberculin test positive  1  1/223 (0.45%) 
Musculoskeletal and connective tissue disorders   
Ankylosing spondylitis  1  1/223 (0.45%) 
Joint instability  1  1/223 (0.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Thyroid cancer  1  1/223 (0.45%) 
Thyroid neoplasm  1  1/223 (0.45%) 
Renal and urinary disorders   
Nephrolithiasis  1  2/223 (0.90%) 
Skin and subcutaneous tissue disorders   
Skin necrosis  1  1/223 (0.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sarilumab
Affected / at Risk (%)
Total   62/223 (27.80%) 
Blood and lymphatic system disorders   
Neutropenia  1  21/223 (9.42%) 
Gastrointestinal disorders   
Aphthous stomatitis  1  12/223 (5.38%) 
General disorders   
Injection site reaction  1  14/223 (6.28%) 
Infections and infestations   
Nasopharyngitis  1  16/223 (7.17%) 
Upper respiratory tract infection  1  13/223 (5.83%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 14.1
The study was prematurely discontinued after approximately 1.5 years, when the ankylosing spondylitis development program was discontinued due to lack of efficacy in the DRI11073 study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01118728     History of Changes
Other Study ID Numbers: LTS11298
2010-019263-11 ( EudraCT Number )
First Submitted: May 5, 2010
First Posted: May 7, 2010
Results First Submitted: May 24, 2017
Results First Posted: June 21, 2017
Last Update Posted: June 21, 2017