An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00751881

Purpose

The objective of the study is to evaluate the effect of two doses of Teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis. The effect on worsening of disability and fatigue will also be evaluated, as well as long term safety.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Teriflunomide (HMR1726) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis

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 patient-year) [ Time Frame: Average of 2 years (between 1 and 3 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to disability progression as assessed by the Kurtzke Expanded Disability Status Scale (EDSS) [ Time Frame: Average of 2 years (between 1 and 3 years) ] [ Designated as safety issue: No ]
Change from baseline in subject reported fatigue as assessed by the Fatigue Impact Scale (FIS) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Change from baseline in Short Form generic health survey [36 items] (SF-36) scale [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	1110
Study Start Date:	August 2008
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 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
Placebo Comparator: Placebo	Drug: Placebo Matching tablet, oral administration once daily

Detailed Description:

The study consists of 2 phases:

a double-blind treatment phase where patients receive either Teriflunomide 7 mg or Teriflunomide 14 mg or placebo until a fixed common end date which is approximately 48 weeks after randomization of the last patient.
an open-label treatment phase where the patients who complete the double-blind treatment period have the opportunity to continue or switch to Teriflunomide 14 mg for 48 weeks.

The total study period per patient will be broken up as follows:

Screening period: up to 4 weeks,
Double-blind treatment period: expected to be between 48 and 154 weeks,
safety extension open-label treatment period: 48 weeks,
Post-washout follow-up period: 4 weeks after last treatment intake.

Consequently the duration of the study period per patient is expected to be between 56 and 210 weeks depending on when the patient is randomized and if he/she continue with the open-label extension period.

Eligibility

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

Criteria

Inclusion Criteria:

Relapsing multiple sclerosis,
Two relapses in prior 2 years or one relapse in prior year.

Exclusion Criteria:

Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
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.
Human immunodeficiency virus (HIV) positive,
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: NCT00751881

Show 201 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:	NCT00751881 History of Changes
Other Study ID Numbers:	EFC10531, EudraCT : 2007-004452-36
Study First Received:	May 7, 2008
Last Updated:	February 19, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

relapsing multiple sclerosis

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