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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis Relapse

In brief

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)

Key facts

Study ID

NCT01252355

Run by

Sanofi

People needed

534

Starts

2011-01-01

Expected to finish

2013-04-01

Last updated by the study team

2014-06-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with relapsing forms of MS treated with IFN-beta
• Stable dose of IFN-beta (approved brand) for at least 6 months prior to randomization
• Disease activity in the 12 months prior to randomization and after first 3 months of IFN-beta treatment (defined by at least 1 relapse supported by EDSS or equivalent neurological examination, or, at least 1 brain or spinal cord MRI with at least one T1 gadolinium enhancing lesion)

You may not qualify if…

• McDonald criteria for MS diagnosis not met at time of screening visit
• EDSS score greater than (>) 5.5 at randomization visit
• A relapse within 30 days prior randomization
• Persistent significant or severe infection
• Patients must not have used adrenocorticotrophic hormone or systemic corticosteroids for 2 weeks prior to randomization
• Prior or concomitant use of cytokine therapy (except baseline interferons), glatiramer acetate or intravenous immunoglobulins in the 3 months preceding randomization
• Liver function impairment or persisting elevations (confirmed by retest) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or direct bilirubin greater than 2 times the upper limit of normal range (ULN)
• Active hepatitis or hepatobiliary disease or known history of severe hepatitis
• Pregnant or breast-feeding women or those who were planning to become pregnant during the study
• Significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia
• Human Immunodeficiency Virus (HIV) positive
• Known history of active tuberculosis not adequately treated
• Prior use within 2 years preceding randomization or concomitant use of cladribine and mitoxantrone
• Prior use within 6 months preceding randomization or concomitant use of natalizumab, or any other immunosuppressive agents such as azathioprine, cyclophosphamide, cyclosporine, methotrexate, mycophenolate, or fingolimod
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840005 — Cordova, Alaska, United States
• Investigational Site Number 840003 — Phoenix, Arizona, United States
• Investigational Site Number 840011 — Oceanside, California, United States
• Investigational Site Number 840036 — Fort Collins, Colorado, United States
• Investigational Site Number 840012 — Maitland, Florida, United States
• Investigational Site Number 840013 — Ormond Beach, Florida, United States
• Investigational Site Number 840055 — Pompano Beach, Florida, United States
• Investigational Site Number 840021 — St. Petersburg, Florida, United States
• Investigational Site Number 840004 — Tampa, Florida, United States
• Investigational Site Number 840047 — Tampa, Florida, United States
• Investigational Site Number 840034 — Chicago, Illinois, United States
• Investigational Site Number 840037 — Elk Grove Village, Illinois, United States
• Investigational Site Number 840033 — Louisville, Kentucky, United States
• Investigational Site Number 840041 — Baltimore, Maryland, United States
• Investigational Site Number 840028 — Baltimore, Maryland, United States
• Investigational Site Number 840016 — Clinton Township, Michigan, United States
• Investigational Site Number 840031 — St Louis, Missouri, United States
• Investigational Site Number 840030 — St Louis, Missouri, United States
• Investigational Site Number 840009 — Missoula, Montana, United States
• Investigational Site Number 840023 — Albuquerque, New Mexico, United States
• Investigational Site Number 840015 — New York, New York, United States
• Investigational Site Number 840027 — Charlotte, North Carolina, United States
• Investigational Site Number 840006 — Bismarck, North Dakota, United States
• Investigational Site Number 840007 — Fargo, North Dakota, United States
• Investigational Site Number 840049 — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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