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

NCT01061723 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2017-08-08

Study results available
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Summary

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

Conditions

Interventions

DRUG

Sarilumab

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Lithuania
  • Netherlands
  • Poland
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01061723 on ClinicalTrials.gov