Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00803049

Purpose

The primary objective of this study is to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) patients with relapse.

The secondary objective is to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: teriflunomide (HMR1726)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Number of patients with adverse events [ Time Frame: Up to a maximum of 292 weeks (4 weeks after last treatment intake) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to disability progression as assessed by Expanded Disability Status Scale (EDSS) [ Time Frame: Up to a maximum of 288 weeks ] [ Designated as safety issue: No ]
Proportion of patients free of disability progression [ Time Frame: Up to a maximum of 288 weeks ] [ Designated as safety issue: No ]
Annualized relapse rate (number of confirmed relapses per patient-year) [ Time Frame: Up to a maximum of 288 weeks ] [ Designated as safety issue: No ]
Burden of disease : Change from baseline in the volume of abnormal brain tissue as measured by brain MRI [ Time Frame: Up to a maximum of 288 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1080
Study Start Date:	October 2006
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Teriflunomide 7 mg	Drug: teriflunomide (HMR1726) Tablet, oral administration once daily.
Experimental: Teriflunomide 14 mg	Drug: teriflunomide (HMR1726) Tablet, oral administration once daily.

Detailed Description:

Patients completing the EFC6049 (HMR1726D/3001) study are given the opportunity to continue in the extension study;

patients receiving teriflunomide 7 mg or 14 mg are blindly maintained on the same dose of teriflunomide.
patients receiving placebo are randomized to teriflunomide 7 mg or 14 mg.

The study period per patient is broken down as follows:

Double-blind treatment: up to a maximum of 288 weeks,
Post-washout follow-up: 4 weeks after last treatment intake.

The total duration of the extension is 292 weeks (about 6 years) from the first patient enrolled.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient who has completed the previous double-blind placebo-controlled study EFC6049 and who does not meet criteria for treatment withdrawal.
Willingness to participate in a long-term safety/efficacy trial.

Exclusion Criteria:

Any known condition or circumstance that would prevent in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803049

Show 21 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00803049 History of Changes
Other Study ID Numbers:	LTS6050, 2006-003361-14
Study First Received:	December 1, 2008
Last Updated:	March 31, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Multiple Sclerosis
Oral treatment

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012