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

Phase 2

Terminated

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: Sarilumab

• Registration Number: NCT01118728
• Lead Sponsor: Sanofi

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

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 Timeline

• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Study Start: 2010-06
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Disposition First Submitted: 2013-01-11
• Disposition First Submitted QC: 2013-01-11
• Disposition First Posted: 2013-01-21
• Status Verified: 2017-05
• Results First Submitted: 2017-05-24
• Results First Submitted QC: 2017-05-24
• Last Update Submitted: 2017-05-24
• Results First Posted: 2017-06-21
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 223

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sarilumab	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Any Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and Treatment Discontinuation	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

Name	Time	Method
Percentage of Participants Who Achieved 20% Response in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20)	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).

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇪🇸 Barcelona, Spain