A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00883337

Purpose

The primary objective is to assess the effectiveness of 2 doses of teriflunomide in comparison to interferon beta-1a in patients with patients with relapsing multiple sclerosis. A secondary objective is to evaluate the safety and tolerability of 2 doses of Teriflunomide in comparison to interferon beta-1a.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: teriflunomide (HMR1726) Drug: interferon beta-1a	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon-beta Interferon beta 1a Interferons

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Time to failure (first occurrence of relapse or permanent study treatment discontinuation for any cause whichever comes first) [ Time Frame: average of 20 months (between 12 months and 30 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Annualized relapse rate (number of relapses per patient-year) [ Time Frame: average of 20 months (between 12 months and 30 months) ] [ Designated as safety issue: No ]
Subject reported fatigue as assessed by the Fatigue Impact Scale (FIS) [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]
Subject satisfaction as assessed by the Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: every 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	April 2009
Estimated Study Completion Date:	July 2012
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Teriflunomide 7 mg	Drug: teriflunomide (HMR1726) Tablet, oral administration once a day
Experimental: Teriflunomide 14 mg	Drug: teriflunomide (HMR1726) Tablet, oral administration once a day
Active Comparator: Interferon beta-1a	Drug: interferon beta-1a Solution, up to 44 mcg, subcutaneous injection three times per week Other Name: Rebif

Detailed Description:

The study consists of 2 phases:

an initial treatment phase where patients receive either Teriflunomide 7 mg or Teriflunomide 14 mg or Interferon beta-1a until a fixed common end date which is approximately 48 weeks after randomization of the last patient.
an extension treatment phase where the patients who complete the initial treatment period have the opportunity to continue or switch to Teriflunomide 14 mg for 48 weeks.

The total study period per patient is broken up as follows:

Screening period: up to 4 weeks,
Initial treatment period: expected to be between 48 and 126 weeks,
Extension 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 182 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 and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with relapsing forms of multiple sclerosis meeting McDonald's criteria for MS diagnosis at time of screening visit, and EDSS score ≤5.5 at screening visit
Provided informed consent with signature on informed consent form

Exclusion Criteria:

Patients with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia
Persistent significant or severe infection
Liver function impairment or known history of hepatitis
Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 2 weeks prior to randomization
Human immunodeficiency virus (HIV) positive patients
Prior use of Rebif, or prior or concomitant use of other interferons in the 3 months prior to randomization
Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, or natalizumab
Pregnant or breast-feeding women

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: NCT00883337

Show 60 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00883337 History of Changes
Other Study ID Numbers:	EFC10891, 2008-006226-34
Study First Received:	April 16, 2009
Last Updated:	October 10, 2011
Health Authority:	Spain: Ethics Committee

Keywords provided by Sanofi-Aventis:

Relapsing-remitting 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
Interferon-beta

Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on February 09, 2012