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

A Single Arm Phase IV Clinical Trial to Describe 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.

Study Overview

• Status: Completed
• Conditions: Relapsing Multiple Sclerosis
• Intervention / Treatment: Drug: TERIFLUNOMIDE HMR1726

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Ahmedabad, India, 380054
    • Investigational Site Number :024
  • Bengaluru, India, 560054
    • Investigational Site Number :017
  • Chandigarh, India, 160012
    • Investigational Site Number :001
  • Coimbatore, India
    • Investigational Site Number :023
  • Gurgaon, India, 122001
    • Investigational Site Number :007
  • Gurgaon, India
    • Investigational Site Number :026
  • Kochi, India, 682041
    • Investigational Site Number :005
  • Kolkata, India, 700068
    • Investigational Site Number :006
  • Lucknow, India, 226003
    • Investigational Site Number :011
  • Ludhiana, India, 141001
    • Investigational Site Number :020
  • Nashik, India, 422001
    • Investigational Site Number :018
  • New Delhi, India
    • Investigational Site Number :025
  • Pune, India, 411004
    • Investigational Site Number :014
  • Thiruvananthapuram, India, 695011
    • Investigational Site Number :022

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	Incidence of adverse events	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized relapse rate	Number of relapses per patient-year	1 year
First relapse	Time to first relapse	1 year
Relapse free	Proportion of patients who are relapse free	1 year
Neurological impairment/disability	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.	Baseline to 3 months, 6 months, 9 months and 1 year
Disability progression	Proportion of patients free of disability progression	1 year
Drug compliance	Percentage of patients who are treatment compliant assessed using patient diary	1 year

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Actual): May 13, 2022
• Study Completion (Actual): May 13, 2022

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Teriflunomide
• Other Study ID Numbers: TERIFL08918; U1111-1205-3009 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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/

Drug and device information, study documents

• 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