Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis - Full Text View

Purpose

The purpose of this study is to determine the effects of teriflunomide on: frequency of relapses; accumulation of disability, measured by Expanded Disability Status Scale (EDSS); burden of disease, measured by magnetic resonance imaging (MRI); subject-reported fatigue; and safety and tolerability.

The 2-years double-blind placebo controlled period is followed by a long term open-label extension study LTS6050 with two doses of Teriflunomide.

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

MedlinePlus related topics:

Multiple Sclerosis

U.S. FDA Resources

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

Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Expanded Disability Status [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cerebral MRI [ Time Frame: every 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1080
Study Start Date:	September 2004
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
3: Placebo Comparator	Drug: placebo oral administration once daily

Eligibility

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

Criteria

Inclusion Criteria:

Multiple sclerosis (MS) subjects,who are ambulatory (EDSS of ≤ 5.5)
Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing)
Meeting McDonald's criteria for MS diagnosis
Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial
No relapse onset in the preceding 60 days prior to randomization
During the 4 weeks prior to randomization, subjects must have been clinically stable, without adrenocorticotrophic hormone (ACTH) or systemic steroid treatment.
Signed informed consent form

Exclusion Criteria:

Patients with clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease
Patients with significantly impaired bone marrow function
Pregnant or nursing women
Alcohol or drug abuse
Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134563

Show 21 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Principal Investigator:	Paul O'Connor, MD	St. Michael's Hospital, Toronto

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD )
Study ID Numbers:	EFC6049, EudraCT 2004-000555-42, HMR1726D/3001, LTS6050
First Received:	August 23, 2005
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00134563
Health Authority:	Canada: Health Canada; France: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Sanofi-Aventis:

Multiple Sclerosis

Relapsing Remitting

Secondary Progressive

Progressive Relapsing

Study placed in the following topic categories:

Autoimmune Diseases

Multiple Sclerosis

Demyelinating Diseases

Neoplasm Metastasis

Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases

Sclerosis

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes

Immune System Diseases

Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00134563