NCT01118728|TerminatedPhase 2ResultsDMC

Study Stopped

Lack of benefit on efficacy

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

SUSTAIN

A Multicenter Uncontrolled Extension Study Evaluating the Long Term Safety and Efficacy of SAR153191 in Patients With Ankylosing Spondylitis (AS)

Sanofi ClinicalTrials.gov

Compare

2 other identifiers

LTS112982010-019263-11

Study Type

interventional

Target

223

Locations

11 countries

Sites

Timeline

RegisteredMay 2010

StartedJun 2010

CompletionDec 2011

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

223

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jun 2010

Shorter than P25 for phase_2

Geographic Reach

11 countries

11 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

May 5, 2010

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed

25 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed

5.6 years until next milestone

Results Posted

Study results publicly available

June 21, 2017

Completed

Last Updated

June 21, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

May 5, 2010

Results QC Date

May 24, 2017

Last Update Submit

May 24, 2017

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

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).
Baseline up to the end of study (66 weeks)

Secondary Outcomes (1)

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)

Study Arms (1)

Sarilumab

EXPERIMENTAL

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

Interventions

SarilumabDRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Also known as: SAR153191, REGN88

Sarilumab

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participant with AS who participated and completed 12-week treatment in study DRI11073-NCT01061723.

You may not qualify if:

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.

Contact the study team to confirm eligibility.