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

Conditions	Phase	Intervention Type
MS	Phase 3	Drug Teriflunomide (HMR1726) Drug Matching placebo

View trial NCT01252355 on www.clinicaltrials.gov

Contacts

Please use the information below to contact the trial coordinators.

For site information, send an email with site number to

Contact-Us@sanofi-aventis.com

Eligibility

Ages Eligible for Study: 18 years to 55 years
Genders Eligible for Study: Both

Keywords

Inclusion Criteria

- Patient with relapsing forms of multiple sclerosis (MS) treated with Interferon beta
(IFN-β) defined by:

- Stable dose of IFN-β for at least 6 months prior to randomization,

and

- Disease activity in the 12 months prior to randomization and after first 3 months of
IFN-β treatment (at least one relapse supported by Expanded Disability status Scale
(EDSS) or equivalent neurological examination, or, at least one brain or spinal cord
Magnetic Resonance Imaging (MRI) with at least one T1 gadolinium enhancing lesion).

Exclusion Criteria

- < 18 years of age or ≥ 56 years of age.

- McDonald's criteria for MS diagnosis not met at time of screening visit.

- EDSS score > 5.5 at screening visit.

- Not treated with a stable dose of IFN-β for at least 6 months prior to randomization
or not tolerating IFN-β or not expected to remain on IFN-β for the duration of the
study.

- A relapse within 30 days prior randomization.

- Human Immunodeficiency Virus (HIV) positive patient.

- Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant
agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate,
mycophenolate or fingolimod in previous 6 months.

- Prior use in the 3 months preceding randomization of cytokine therapy (except
baseline IFN-β), glatiramer acetate or intravenous immunoglobulins, or concomitant
use of these treatments.

- Prior or concomitant use of natalizumab (Tysabri®) in previous 6 months.

- Pregnant or breast-feeding women or those who plan to become pregnant during the
study.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Detailed Description

Primary Objective: - Assess 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-β). Secondary Objectives: - Assess the effect of Teriflunomide in comparison to placebo when added to interferon beta (IFN-β) 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-β therapy. - Assess the pharmacokinetics of Teriflunomide in use in addition to baseline IFN-β 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01252355

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