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

Sponsor:	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 Drug: Interferon-beta	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon-beta Interferons

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Number of patients with adverse events [ Time Frame: up to a maximum of 36 weeks (12 weeks after the last dose of study medication) ] [ Designated as safety issue: Yes ]
Number of patients with clinically significant abnormalities [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Clinically significant abnormalities based on laboratory tests, electrocardiograms (ECG) and abdominal ultrasound of the pancreas.

Secondary Outcome Measures:

Total number of gadolinium enhancing T1-lesions per Magnetic Resonance Imaging (MRI) scan [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Burden of disease [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change from baseline in the total volume of all lesions as measured by T2-weighted MRI scan.
Annualized relapse rate (number of relapses per subject-year) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	116
Study Start Date:	May 2007
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Teriflunomide 7 mg	Drug: teriflunomide (HMR1726) Tablet, oral administration once daily. Drug: Interferon-beta Inteferon-beta therapy, same stable dose as before enrolment, continued during the study.
Experimental: Teriflunomide 14 mg	Drug: teriflunomide (HMR1726) Tablet, oral administration once daily. Drug: Interferon-beta Inteferon-beta therapy, same stable dose as before enrolment, continued during the study.
Placebo Comparator: Placebo	Drug: placebo Matching tablet, oral administration once daily. Drug: Interferon-beta Inteferon-beta therapy, same stable dose as before enrolment, continued during the study.

Detailed Description:

The study period per patient is about 44 weeks broken as follows:

a screening period up to 4 weeks,
24-week treatment period,
16-week post washout follow-up period.

The patients successfully completing the study will be offered the opportunity to enter the optional long-term extension study LTS6047.

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 immunosuppressant 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

No publications provided

Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00489489 History of Changes
Other Study ID Numbers:	PDY6045, 2006-003134-14, HMR1726D-2003
Study First Received:	June 20, 2007
Last Updated:	June 17, 2011
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

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

Interferon-beta
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012