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

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

Purpose

The purpose of this study is to document the long-term safety as primary objective of teriflunomide 7mg or 14 mg in MS patients who participated to the efficacy study (EFC6049) double blind placebo controlled during two years of treatment and also to document long-term efficacy on disability progression, MRI parameters and EDSS variation as secondary objective.

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

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Safety: adverse events, physical examinations, vital signs, blood and urine laboratory parameters, ultra-sound image of pancreas [ Time Frame: up to a maximum of 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Expanded Disability Status Scores [ Time Frame: up to a maximum of 4 years ] [ Designated as safety issue: No ]
Annualized MS relapse rate [ Time Frame: up to a maximum of 4 years ] [ Designated as safety issue: No ]
MRI variables [ Time Frame: up to a maximum of 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	1080
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 7 mg	Drug: teriflunomide (HMR1726) oral administration - once daily
2: Experimental 14 mg	Drug: teriflunomide (HMR1726) oral administration - once daily

Eligibility

Ages Eligible for Study:	18 Years to 57 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients completing the previous double-blind placebo-controlled study EFC6049 and do 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 18 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	LTS6050, EudraCT 2006-003361-14, EFC6049
Study First Received:	December 1, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00803049
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Multiple Sclerosis
Oral treatment

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

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

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009