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

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

Purpose

The primary objective of this study was to determine the effects of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis.

The secondary objectives were to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale (EDSS); the burden of disease as measured by magnetic resonance imaging (MRI); subject-reported fatigue; and to evaluate the safety and tolerability of teriflunomide.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Teriflunomide (HMR1726) Drug: placebo	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:	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

Resource links provided by NLM:

MedlinePlus related topics: Fatigue Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Annualized relapse rate (number of relapses per subject/year) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to disability progression as assessed by Kurtzke Expended Disability Status Scale (EDSS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Proportion of subjects free of disability progression [ Time Frame: 6 months, 1 year and 2 years ] [ Designated as safety issue: No ]
Burden of disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Change from baseline in the volume of abnormal brain tissue as assessed by cerebral Magnetic Resonance Imaging (MRI)
Subject-reported fatigue as assessed by the Fatigue Impact Scale (FIS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	1088
Study Start Date:	September 2004
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (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
Placebo Comparator: Placebo	Drug: placebo Matching tablet, oral administration once daily

Detailed Description:

The study period per patient was approximatively 128 weeks broken down as follows:

Screening period up to 4 weeks,
Double-blind treatment period of 108 weeks (approximatively 2 years),
Post-treatment wash-out follow-up period of 16 weeks (if not entering in the extension study LTS6050).

The patients successfully competing the study treatment were offered the opportunity to enter an optional long-term extension study LTS6050.

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 were 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 30 days prior to randomization, subjects should 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 have prevented 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 (Canada)

More Information

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

O'Connor P, Wolinsky JS, Confavreux C, Comi G, Kappos L, Olsson TP, Benzerdjeb H, Truffinet P, Wang L, Miller A, Freedman MS; TEMSO Trial Group. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011 Oct 6;365(14):1293-303.

Responsible Party:	Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00134563 History of Changes
Other Study ID Numbers:	EFC6049, 2004-000555-42, HMR1726D/3001
Study First Received:	August 23, 2005
Last Updated:	August 8, 2011
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

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
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