To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis

Study Overview
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Brief Summary
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Primary Objective: To describe the safety of teriflunomide in patients with relapsing forms of multiple sclerosis. Secondary Objective: To describe the efficacy of teriflunomide in patients with relapsing forms of multiple sclerosis.

Detailed Description
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The study duration is one year; post treatment safety follow up visit will be conducted 4 weeks after the patient takes the last dose of teriflunomide

Official Title
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A Single Arm Phase IV Clinical Trial to Describe the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis

Conditions
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Relapsing Multiple Sclerosis

Intervention / Treatment
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* Drug: TERIFLUNOMIDE HMR1726


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age of patients ≥ 18 years Patients with relapsing form of multiple sclerosis at time of screening visit. Signed written informed consent. Exclusion criteria: Patients with hypersensitivity to teriflunomide, leflunomide, or to any excipients in the tablets. Liver function impairment or persisting elevations of serum glutamic pyruvic transaminase (SGPT/ALT), serum glutamic oxaloacetic transaminase (SGOT/AST), greater than two times the upper limit of normal (ULN) during screening visit. Known history of pre-existing acute or chronic liver disease. Patients with significantly (as per Investigator's discretion) impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia. Known history of severe immunodeficiency, acute or severe active infections. Female patients with a positive pregnancy test at screening or women of child-bearing potential who do not agree to use effective methods of contraception throughout the course of the study. Male patients unwilling to use reliable contraception during the course of the study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aubagio®/Teriflunomide<br>Single dose of Aubagio® to be taken orally, once daily in the morning | Drug: TERIFLUNOMIDE HMR1726<br>* Pharmaceutical form: Tablet Route of administration: Oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) | Incidence of adverse events | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized relapse rate | Number of relapses per patient-year | 1 year | 
| First relapse | Time to first relapse | 1 year | 
| Relapse free | Proportion of patients who are relapse free | 1 year | 
| Neurological impairment/disability | Expanded Disability Status Scale (EDSS) will be used to compare disability from baseline. The EDSS ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. | Baseline to 3 months, 6 months, 9 months and 1 year | 
| Disability progression | Proportion of patients free of disability progression | 1 year | 
| Drug compliance | Percentage of patients who are treatment compliant assessed using patient diary | 1 year |