Pilot Study of Teriflunomide as Adjunctive Therapy to Interferon-Beta in Subjects With Multiple Sclerosis - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00489489

Purpose

The primary objective of this study is to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in subjects with multiple sclerosis who are currently on a stable dose of interferon-β.

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

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferons Interferon beta Interferon-beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Randomized, Multinational, Double-Blind, Placebo-Controlled, Parallel-Group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Interferon-Beta in Subjects With Multiple Sclerosis.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Tolerability and safety data based on adverse event reports, physical examinations, laboratory evaluations, electrocardiograms and abdominal ultrasound of the pancreas. [ Time Frame: study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total number of gadolinium enhancing T1-lesions per MRI (Magnetic Resonance Imaging) scan, Percentage change from baseline in burden of disease (based on T2-lesions per MRI), Annualized relapse rate. [ Time Frame: study period ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	June 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 7 mg	Drug: teriflunomide (HMR1726) in combination with a stable dose of Interferon-β
2: Experimental 14 mg	Drug: teriflunomide (HMR1726) in combination with a stable dose of Interferon-β
3: Placebo Comparator	Drug: placebo in combination with a stable dose of Interferon-β

Eligibility

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

Criteria

Inclusion Criteria:

Subjects with definite multiple sclerosis (MS) diagnosis according to McDonald's criteria and who are ambulatory (Expanded Disability Status Scale [EDSS] of less or equal to 5.5)
On a stable dose of interferon-beta for at least 26 weeks prior to the screening visit
No onset of MS relapse in the preceding 60 days prior to randomization
Clinically stable for 4 weeks prior to randomization

Exclusion Criteria:

Patients with other chronic disease of the immune system, liver function impairment or chronic pancreatic disease
Pregnant or nursing women
Alcohol or drug abuse
Use of cladribine, mitoxantrone, or other immunosuppresant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
Human immunodeficiency virus (HIV) positive status
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: NCT00489489

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	PDY6045, EudraCT 2006-003134-14, HMR1726D-2003, LTS6047
Study First Received:	June 20, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00489489
Health Authority:	Canada: Health Canada; Germany: Paul-Ehrlich-Institut; Spain: Spanish Agency of Medicines

Keywords provided by Sanofi-Aventis:

MS
interferon-beta
adjunctive therapy
relapses

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon-beta

Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Anti-Infective Agents
Pathologic Processes
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009