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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03856619
Recruitment Status : Active, not recruiting
First Posted : February 27, 2019
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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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 relapsing forms of multiple sclerosis.


Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Drug: TERIFLUNOMIDE HMR1726 Phase 4

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm Phase IV Clinical Trial to Describe the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Aubagio®/Teriflunomide
Single dose of Aubagio® to be taken orally, once daily in the morning
 Drug: TERIFLUNOMIDE HMR1726

Pharmaceutical form: Tablet

Route of administration: Oral


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: 1 year ]
    Incidence of adverse events


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03856619


Locations
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India
Investigational Site Number :024
Ahmedabad, India, 380054
Investigational Site Number :017
Bengaluru, India, 560054
Investigational Site Number :001
Chandigarh, India, 160012
Investigational Site Number :023
Coimbatore, India
Investigational Site Number :007
Gurgaon, India, 122001
Investigational Site Number :026
Gurgaon, India
Investigational Site Number :005
Kochi, India, 682041
Investigational Site Number :006
Kolkata, India, 700068
Investigational Site Number :011
Lucknow, India, 226003
Investigational Site Number :020
Ludhiana, India, 141001
Investigational Site Number :018
Nashik, India, 422001
Investigational Site Number :025
New Delhi, India
Investigational Site Number :014
Pune, India, 411004
Investigational Site Number :022
Thiruvananthapuram, India, 695011
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03856619    
Other Study ID Numbers: TERIFL08918
U1111-1205-3009 ( Other Identifier: UTN )
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 26, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Teriflunomide
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors