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OpenTrials
Completed

NCT Number: NCT03856619

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number :024, Ahmedabad, India

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

teriflunomide HMR1726

Drug

Pharmaceutical form: Tablet

Route of administration: Oral

Primary outcomes

  1. Adverse events (AEs)

    Time frame: 1 year

    Incidence of adverse events

Secondary outcomes

  1. Annualized relapse rate

    Time frame: 1 year

    Number of relapses per patient-year

  2. First relapse

    Time frame: 1 year

    Time to first relapse

  3. Relapse free

    Time frame: 1 year

    Proportion of patients who are relapse free

  4. Neurological impairment/disability

    Time frame: Baseline to 3 months, 6 months, 9 months and 1 year

    Expanded Disability Status Scale (EDSS) will be used to compare disability from baseline. The EDSS ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.

  5. Disability progression

    Time frame: 1 year

    Proportion of patients free of disability progression

  6. Drug compliance

    Time frame: 1 year

    Percentage of patients who are treatment compliant assessed using patient diary

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Single Arm Phase IV Clinical Trial to Describe the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis

Acronym: SAFE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 27, 2019
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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