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Trial record 44 of 372 for:    Ankylosing Spondylitis

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 224 screened participants, 223 participants were enrolled and treated. One participant withdrew consent before randomization.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Sarilumab
STARTED   223 
COMPLETED   0 
NOT COMPLETED   223 
Adverse Event                17 
Lack of Efficacy                27 
Sponsor's decision to discontinue study                172 
Withdrawal by Subject                3 
Lost to Follow-up                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants who received at least one dose of the study treatment after signature of the informed consent.

Reporting Groups
  Description
Sarilumab 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.

Baseline Measures
   Sarilumab 
Overall Participants Analyzed 
[Units: Participants]
 223 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.6  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      63  28.3% 
Male      160  71.7% 


  Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-US@sanofi.com



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