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Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta

NCT01252355 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2014-06-09

Study results available
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Summary

The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta).

The secondary objectives were:

* Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on:

* Disease activity as measured by brain Magnetic Resonance Imaging (MRI)
* Disability progression
* Burden of disease and disease progression as measured by brain MRI
* Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy
* Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy
* Assess associations between variations in genes and clinical outcomes (safety and efficacy)
* Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life
* Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)

Conditions

  • Multiple Sclerosis Relapse

Interventions

DRUG

Teriflunomide

Film-coated tablet Oral administration

DRUG

Placebo (for teriflunomide)

Film-coated tablet Oral administration

DRUG

Interferon-beta (IFN-beta)

Any of the IFN-beta which are approved for marketed use in the country where the patient is enrolled. Administration according to the package insert.

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
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • Netherlands
  • Norway
  • Portugal
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Tunisia
  • United Kingdom

Study Locations

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Entities

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 NCT01252355 on ClinicalTrials.gov