A study on TeriFlunomidE for multiple sclerosis patients to understand the safety and clinical profile.
- Conditions
- Health Condition 1: G35- Multiple sclerosis
- Registration Number
- CTRI/2019/03/017978
- Lead Sponsor
- SanofiSynthelaboIndiaPrivate Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Age of patients >= 18 years
- Patients with relapsing form of multiple
sclerosis at time of screening visit.
- Signed written informed consent.
1. Patients with hypersensitivity to teriflunomide, leflunomide, or to any excipients in the tablets.
2. 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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Incidence, duration, severity (mild/moderate/severe), and outcome of any adverse events (AEs), serious adverse events (SAEs) during the study duration 13 monthsTimepoint: 1. 13 months
- Secondary Outcome Measures
Name Time Method 1.Annualized relapse rate, defined as number of relapses per patient-year ,TIMEPOINTS: 12 months <br/ ><br>2. Time to first relapse, TIMEPOINTS: 12 months <br/ ><br>3.Drug compliance (using patient diary), TIMEPOINTS: 12 months <br/ ><br>Patient diary will capture if any drug dose is missed and safety events (if any) <br/ ><br>Timepoint: 1. Timepoints: 12 months <br/ ><br>1. TIMEPOINTS: 12 months <br/ ><br>2. Timepoints: 12 months <br/ ><br>3. TIMEPOINTS: 12 months <br/ ><br>Patient diary will capture if any drug dose is missed and safety events (if any) <br/ ><br>