Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00622700

Purpose

The primary objective is to demonstrate that early intervention with Teriflunomide in patients presenting with their first clinical episode consistent with MS prevents or delays conversion to clinically definite Multiple Sclerosis [MS].

The secondary objectives are:

to demonstrate that Teriflunomide prevents or delays conversion to MS based on the revised McDonald Criteria and delays disability progression,
to evaluate the long-term safety of Teriflunomide,

in this population.

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, Investigator) Primary Purpose: Treatment
Official Title:	An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period

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:

Conversion to clinically definite MS as defined by the occurrence of a relapse [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Conversion to definite MS as demonstrated by the dissemination of cerebral Magnetic Resonance Imaging (MRI) lesions in time (revised McDonald criteria 2005) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
Annualized relapse rate (number of relapses per subject/year) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
Burden of disease [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
Change from baseline in the volume of abnormal brain tissue as assessed by cerebral MRI
Disability progression as assessed by the Kurtzke Expanded Disability Status Scale (EDSS) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
Patient reported fatigue as assessed by the Fatigue Impact Scale (FIS) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	780
Study Start Date:	February 2008
Estimated Study Completion Date:	November 2015
Estimated Primary Completion Date:	November 2015 (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 4 periods:

Screening period: up to 4 weeks,
Placebo-controlled treatment period: up to 108 weeks (at least 24 weeks for patients who experienced conversion to clinical definite MS),
Extension treatment period (without placebo-control): up to 192 weeks or until the last patient entering in the extension period completes 24 weeks of the extension period, whichever comes first.
Post-treatment washout period: 4 weeks after last treatment intake.

The maximal duration of the study period per patient is expected to be 308 weeks if he/she continues in the extension treatment period (116 weeks if he/she does not continue).

Eligibility

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

Criteria

Inclusion Criteria:

First acute or subacute, well-defined neurological event consistent with demyelination (i.e. optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes),
Onset of MS symptoms occurring within 90 days of randomization,
A screening MRI scan with 2 or more T2 lesions at least 3 mm in diameter that are characteristic of MS.

Exclusion Criteria:

Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
Significantly impaired bone marrow function,
Pregnancy or nursing,
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.

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: NCT00622700

Contacts

Contact: For site information, send an email with site number to

Contact-Us@sanofi-aventis.com

Show 129 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00622700 History of Changes
Other Study ID Numbers:	EFC6260, HMR1726D-3005, 2006-001152-12
Study First Received:	February 14, 2008
Last Updated:	January 19, 2012
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut

Keywords provided by Sanofi-Aventis:

MS
CIS
CDMS
relapses

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