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

Phase 2TerminatedNCT01118728

Sanofi223 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

223

Conditions

Ankylosing Spondylitis

Interventions

SarilumabDRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (12)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Macquarie Park, New South Wales, Australia

Sanofi-Aventis Administrative Office

Vienna, Austria

Outcomes

Primary Outcomes

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

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)

Secondary Outcomes

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

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)

Data from ClinicalTrials.gov

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