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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: TERIFLUNOMIDE HMR1726

Study type: Interventional

Funder types: Industry

Identifiers

NCT03856619

TERIFL08918

U1111-1205-3009 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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121 participants in 1 patient group

Aubagio®/Teriflunomide

Experimental group

Description:

Single dose of Aubagio® to be taken orally, once daily in the morning

Treatment:

Drug: TERIFLUNOMIDE HMR1726