Relapsing Multiple Sclerosis
Conditions
Brief summary
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
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
Interventions
Pharmaceutical form: Tablet Route of administration: Oral
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | 1 year | Incidence of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First relapse | 1 year | Time to first relapse |
| Relapse free | 1 year | Proportion of patients who are relapse free |
| Annualized relapse rate | 1 year | Number of relapses per patient-year |
| Disability progression | 1 year | Proportion of patients free of disability progression |
| Drug compliance | 1 year | Percentage of patients who are treatment compliant assessed using patient diary |
| Neurological impairment/disability | Baseline to 3 months, 6 months, 9 months and 1 year | 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. |
Countries
India
Outcome results
None listed