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Completed Phase 2 Interventional Results available

Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

ClinicalTrials.gov ID: NCT01061723

Public ClinicalTrials.gov record NCT01061723. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 11, 2026, 4:07 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Primary objective: \- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20) Secondary objectives: * to demonstrate that Sarilumab was effective on: * assessment of higher level of response \[ASAS 40% response criteria (ASAS40)\] * partial remission * disease activity * range of motion * Magnetic Resonance Imaging (MRI) of the spine * to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS

Study identification

NCT ID
NCT01061723
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Sanofi
Industry
Enrollment
301 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2010
Primary completion
May 31, 2011
Completion
May 31, 2011
Last update posted
Aug 7, 2017

2010 – 2011

United States locations

U.S. sites
26
U.S. states
17
U.S. cities
26
Facility City State ZIP Site status
Investigational Site Number 840006 Birmingham Alabama 35205
Investigational Site Number 840033 Anaheim California 92801
Investigational Site Number 840027 Los Angeles California 90048
Investigational Site Number 840007 San Diego California 92108
Investigational Site Number 840013 San Francisco California 94143
Investigational Site Number 840017 Upland California 91786
Investigational Site Number 840009 Boca Raton Florida 33486
Investigational Site Number 840001 Naples Florida 34102
Investigational Site Number 840032 Orlando Florida 32806
Investigational Site Number 840015 Boise Idaho 83702
Investigational Site Number 840021 Rock Island Illinois 61201
Investigational Site Number 840018 Kansas City Kansas 66160-7321
Investigational Site Number 840003 Wheaton Maryland 20902
Investigational Site Number 840029 Worcester Massachusetts 01655
Investigational Site Number 840008 Lansing Michigan 48823
Investigational Site Number 840002 St Louis Missouri 63141
Investigational Site Number 840028 Freehold New Jersey 07728
Investigational Site Number 840016 Albany New York 12206
Investigational Site Number 840036 Syracuse New York 13210
Investigational Site Number 840010 Toledo Ohio 43606
Investigational Site Number 840005 Oklahoma City Oklahoma 73109
Investigational Site Number 840023 Bethlehem Pennsylvania 18015
Investigational Site Number 840014 Duncansville Pennsylvania 16635
Investigational Site Number 840004 Dallas Texas 75231
Investigational Site Number 840030 Houston Texas 77034
Investigational Site Number 840034 Chesapeake Virginia 23320

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 54 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01061723, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 7, 2017 · Synced Sep 11, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01061723 live on ClinicalTrials.gov.

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