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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01118728
• Date of registration: 05/05/2010
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis SUSTAIN
• Scientific title: A Multicenter Uncontrolled Extension Study Evaluating the Long Term Safety and Efficacy of SAR153191 in Patients With Ankylosing Spondylitis (AS)
• Date of first enrolment: June 2010
• Target sample size: 223
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01118728
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Sarilumab

Primary Outcome(s)

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)]

Secondary Outcome(s)

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)]

Secondary ID(s)

LTS11298

2010-019263-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 21/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01118728