Status:
COMPLETED
To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis
Lead Sponsor:
Sanofi
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 re...
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2022
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03856619
Start Date
March 27 2019
End Date
May 13 2022
Last Update
April 19 2023
Active Locations (14)
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1
Investigational Site Number :024
Ahmedabad, India, 380054
2
Investigational Site Number :017
Bengaluru, India, 560054
3
Investigational Site Number :001
Chandigarh, India, 160012
4
Investigational Site Number :023
Coimbatore, India