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

Relapsing Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03856619
• Other study ID #: TERIFL08918
• Secondary ID: U1111-1205-3009
• Status: Completed
• Phase: Phase 4
• Start date: March 27, 2019
• Est. completion date: May 13, 2022

Study information

• Verified date: April 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: May 13, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• TERIFLUNOMIDE HMR1726
Pharmaceutical form: Tablet Route of administration: Oral

Locations

Country	Name	City	State
India	Investigational Site Number :024	Ahmedabad
India	Investigational Site Number :017	Bengaluru
India	Investigational Site Number :001	Chandigarh
India	Investigational Site Number :023	Coimbatore
India	Investigational Site Number :007	Gurgaon
India	Investigational Site Number :026	Gurgaon
India	Investigational Site Number :005	Kochi
India	Investigational Site Number :006	Kolkata
India	Investigational Site Number :011	Lucknow
India	Investigational Site Number :020	Ludhiana
India	Investigational Site Number :018	Nashik
India	Investigational Site Number :025	New Delhi
India	Investigational Site Number :014	Pune
India	Investigational Site Number :022	Thiruvananthapuram

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs)	Incidence of adverse events	1 year
Secondary	Annualized relapse rate	Number of relapses per patient-year	1 year
Secondary	First relapse	Time to first relapse	1 year
Secondary	Relapse free	Proportion of patients who are relapse free	1 year
Secondary	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
Secondary	Disability progression	Proportion of patients free of disability progression	1 year
Secondary	Drug compliance	Percentage of patients who are treatment compliant assessed using patient diary	1 year