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

Ankylosing Spondylitis Clinical Trial

— SUSTAIN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01118728
• Other study ID #: LTS11298
• Secondary ID: 2010-019263-11
• Status: Terminated
• Phase: Phase 2
• First received: May 5, 2010
• Last updated: January 11, 2013
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

• To assess the long term safety of Sarilumab (SAR153191/REGN88) in patients with ankylosing spondylitis (AS)

Secondary Objective:

• To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in patients with AS

Description:

The maximum study duration per participant was to be 267 weeks (approximatively 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 223
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patient 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 patient in this study as per investigator judgment.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Sarilumab
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Locations

Country	Name	City	State
Australia	Sanofi-Aventis Administrative Office	Macquarie Park	New South Wales
Austria	Sanofi-Aventis Administrative Office	Wien
Belgium	Sanofi-Aventis Administrative Office	Diegem
Canada	Sanofi-Aventis Administrative Office	Laval
Czech Republic	Sanofi-Aventis Administrative Office	Praha
France	Sanofi-Aventis Administrative Office	Paris
Hungary	Sanofi-Aventis Administrative Office	Budapest
Lithuania	Sanofi-Aventis Administrative Office	Vilnius
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Poland	Sanofi-Aventis Administrative Office	Warszawa
Spain	Sanofi-Aventis Administrative Office	Barcelona
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  France,  Hungary,  Lithuania,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overview of Adverse events		from study drug intake up to the end of study participation (266 weeks max)	Yes
Secondary	Percentage of participants who achieve a 20% response according to the Assessment in AS Working Group Criteria for response [ASAS20]		up to the end of treatment (260 weeks max)	No