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

Phase 4

Completed

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Drug: TERIFLUNOMIDE HMR1726

• Registration Number: NCT03856619
• Lead Sponsor: Sanofi

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

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-27
• Study Start: 2019-03-27
• Primary Completion: 2022-05-13
• Study Completion: 2022-05-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aubagio®/Teriflunomide	TERIFLUNOMIDE HMR1726	Single dose of Aubagio® to be taken orally, once daily in the morning

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	1 year	Incidence of adverse events

Secondary Outcome Measures

Name	Time	Method
Annualized relapse rate	1 year	Number of relapses per patient-year
First relapse	1 year	Time to first relapse
Relapse free	1 year	Proportion of patients who are relapse free
Neurological impairment/disability	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.
Disability progression	1 year	Proportion of patients free of disability progression
Drug compliance	1 year	Percentage of patients who are treatment compliant assessed using patient diary

Trial Locations

Locations (14)

Investigational Site Number :026; 🇮🇳 Gurgaon, India

Investigational Site Number :014; 🇮🇳 Pune, India

Investigational Site Number :007; 🇮🇳 Gurgaon, India

Investigational Site Number :018; 🇮🇳 Nashik, India

Investigational Site Number :017; 🇮🇳 Bengaluru, India

Investigational Site Number :024; 🇮🇳 Ahmedabad, India

Investigational Site Number :006; 🇮🇳 Kolkata, India

Investigational Site Number :011; 🇮🇳 Lucknow, India

Investigational Site Number :023; 🇮🇳 Coimbatore, India

Investigational Site Number :025; 🇮🇳 New Delhi, India

Investigational Site Number :001; 🇮🇳 Chandigarh, India

Investigational Site Number :005; 🇮🇳 Kochi, India

Investigational Site Number :020; 🇮🇳 Ludhiana, India

Investigational Site Number :022; 🇮🇳 Thiruvananthapuram, India