CompletedPhase 4Relapsing MSNCT03856619

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

  • Adverse events (AEs)

    1 year

    Safety

Other measures (6)

  • Annualized relapse rate

    1 year

    Relapses
  • First relapse

    1 year

    Relapses
  • Relapse free

    1 year

    Relapses
  • Neurological impairment/disability

    Baseline to 3 months, 6 months, 9 months and 1 year

    Disability progression
  • Disability progression

    1 year

    Disability progression
  • Drug compliance

    1 year

Who could take part

Relapsing MS · 18 and over

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Mar 2019

    2. Main results due

      May 2022

    3. Finished

      May 2022

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