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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Pharmaceutical form: Tablet Route of administration: Oral
Investigational Site Number :024
Ahmedabad, India
Investigational Site Number :017
Bengaluru, India
Investigational Site Number :001
Chandigarh, India
Adverse events (AEs)
Incidence of adverse events
Time frame: 1 year
Annualized relapse rate
Number of relapses per patient-year
Time frame: 1 year
First relapse
Time to first relapse
Time frame: 1 year
Relapse free
Proportion of patients who are relapse free
Time frame: 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.
Time frame: Baseline to 3 months, 6 months, 9 months and 1 year
Disability progression
Proportion of patients free of disability progression
Time frame: 1 year
Drug compliance
Percentage of patients who are treatment compliant assessed using patient diary
Time frame: 1 year
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Investigational Site Number :023
Coimbatore, India
Investigational Site Number :007
Gurgaon, India
Investigational Site Number :026
Gurgaon, India
Investigational Site Number :005
Kochi, India
Investigational Site Number :006
Kolkata, India
Investigational Site Number :011
Lucknow, India
Investigational Site Number :020
Ludhiana, India
...and 4 more locations