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An Efficacy Study of Teriflun...

An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis

Last Updated: 2016-07-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2015-08-31

Brief Summary

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The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.

Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.

Other secondary objectives were:

* To assess the effect of the two doses of teriflunomide in comparison to placebo on:

* Fatigue;
* Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.
* To evaluate the safety and tolerability of teriflunomide.

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Detailed Description

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The study consists of:

* A core treatment period: Teriflunomide 7 mg or Teriflunomide 14 mg or placebo was administered in double-blind fashion until a fixed common end date which was approximately 48 weeks after randomization of the last participant.
* An extension treatment period: the highest dose of teriflunomide was administered in open-label fashion to participants who successfully complete the core treatment period and wish to continue.

The overall treatment period was followed by a 4-week elimination follow-up period.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Teriflunomide 7 mg / 14 mg

Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.

Group Type EXPERIMENTAL