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

  • STATUS
    Recruiting
  • participants needed
    193
  • sponsor
    Sanofi
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Updated on 4 December 2020
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multiple sclerosis
teriflunomide
hmr1726

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.

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

Details
Condition Relapsing Multiple Sclerosis
Age 18years - 100years
Treatment Teriflunomide HMR1726
Clinical Study IdentifierNCT03856619
SponsorSanofi
Last Modified on4 December 2020

Eligibility

 Yes No Not Sure

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
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