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

Primary Purpose

Relapsing Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
TERIFLUNOMIDE HMR1726
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Investigational Site Number :024
  • Investigational Site Number :017
  • Investigational Site Number :001
  • Investigational Site Number :023
  • Investigational Site Number :007
  • Investigational Site Number :026
  • Investigational Site Number :005
  • Investigational Site Number :006
  • Investigational Site Number :011
  • Investigational Site Number :020
  • Investigational Site Number :018
  • Investigational Site Number :025
  • Investigational Site Number :014
  • Investigational Site Number :022

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aubagio®/Teriflunomide

Arm Description

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

Outcomes

Primary Outcome Measures

Adverse events (AEs)
Incidence of adverse events

Secondary Outcome Measures

Annualized relapse rate
Number of relapses per patient-year
First relapse
Time to first relapse
Relapse free
Proportion of patients who are relapse free
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.
Disability progression
Proportion of patients free of disability progression
Drug compliance
Percentage of patients who are treatment compliant assessed using patient diary

Full Information

First Posted
February 25, 2019
Last Updated
April 18, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03856619
Brief Title
To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis
Acronym
SAFE
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aubagio®/Teriflunomide
Arm Type
Experimental
Arm Description
Single dose of Aubagio® to be taken orally, once daily in the morning
Intervention Type
Drug
Intervention Name(s)
TERIFLUNOMIDE HMR1726
Intervention Description
Pharmaceutical form: Tablet Route of administration: Oral
Primary Outcome Measure Information:
Title
Adverse events (AEs)
Description
Incidence of adverse events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Annualized relapse rate
Description
Number of relapses per patient-year
Time Frame
1 year
Title
First relapse
Description
Time to first relapse
Time Frame
1 year
Title
Relapse free
Description
Proportion of patients who are relapse free
Time Frame
1 year
Title
Neurological impairment/disability
Description
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.
Time Frame
Baseline to 3 months, 6 months, 9 months and 1 year
Title
Disability progression
Description
Proportion of patients free of disability progression
Time Frame
1 year
Title
Drug compliance
Description
Percentage of patients who are treatment compliant assessed using patient diary
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :024
City
Ahmedabad
ZIP/Postal Code
380054
Country
India
Facility Name
Investigational Site Number :017
City
Bengaluru
ZIP/Postal Code
560054
Country
India
Facility Name
Investigational Site Number :001
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Investigational Site Number :023
City
Coimbatore
Country
India
Facility Name
Investigational Site Number :007
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Investigational Site Number :026
City
Gurgaon
Country
India
Facility Name
Investigational Site Number :005
City
Kochi
ZIP/Postal Code
682041
Country
India
Facility Name
Investigational Site Number :006
City
Kolkata
ZIP/Postal Code
700068
Country
India
Facility Name
Investigational Site Number :011
City
Lucknow
ZIP/Postal Code
226003
Country
India
Facility Name
Investigational Site Number :020
City
Ludhiana
ZIP/Postal Code
141001
Country
India
Facility Name
Investigational Site Number :018
City
Nashik
ZIP/Postal Code
422001
Country
India
Facility Name
Investigational Site Number :025
City
New Delhi
Country
India
Facility Name
Investigational Site Number :014
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Investigational Site Number :022
City
Thiruvananthapuram
ZIP/Postal Code
695011
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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/

Learn more about this trial

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

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