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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00475865

Purpose

The primary objective was 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 Glatiramer Acetate (GA).

The secondary objectives were to estimate the effect of the 2 doses of Teriflunomide in combination with a stable dose of GA, compared to placebo, on Magnetic Resonance Imaging (MRI) parameters, relapse rate and fatigue.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Teriflunomide (HMR1726) Drug: Placebo Drug: Glatiramer Acetate	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) 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 Glatiramer Acetate in Subjects With Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Fatigue MRI Scans Multiple Sclerosis

Drug Information available for: Copolymer 1

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 40 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total number of gadolinium enhancing T1-lesions as measured by MRI (Magnetic Resonance Imaging) scan [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Burden of disease : Change from baseline in the total volume all T2-lesions as measured by MRI scan [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Annualized relapse rate (number of confirmed relapses per patient-year) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Subject reported fatigue as assessed by the Fatigue Impact Scale (FIS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	123
Study Start Date:	April 2007
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

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

Detailed Description:

The duration of the study period for a patient was 44 weeks about broken down as follows:

screening period of 4 weeks,
24-week study treatment period*,
16-week follow-up period after treatment discontinuation.

'*' Patients successfully completing the study were offered the opportunity to enter the 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:

Definite Multiple Sclerosis (MS) diagnosis according to McDonald's criteria and who are ambulatory (Expanded Disability Status Scale [EDSS] ≤ 5.5).
On a stable dose of Glatiramer Acetate (GA) 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:

Other chronic disease of the immune system, liver function impairment or chronic pancreatic disease.
Pregnant or nursing woman.
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: NCT00475865

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Austria
Sanofi-Aventis Administrative Office
Vienna, Austria
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, United Kingdom

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00475865 History of Changes
Other Study ID Numbers:	PDY6046, 2006-004893-29, HMR1726D-2004
Study First Received:	May 18, 2007
Last Updated:	June 17, 2011
Health Authority:	Canada: Health Canada; Germany: Paul-Ehrlich-Institut; Austria: Federal Ministry for Health and Women

Keywords provided by Sanofi-Aventis:

MS
glatiramer acetate
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
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012