A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis
Summary
The primary objective is to assess the effectiveness of 2 doses of teriflunomide in comparison to interferon beta-1a. A secondary objective is to evaluate the safety and tolerability of 2 doses of teriflunomide in comparison to interferon beta-1a.
Description
For the last patient randomized the study period is approximately 68 weeks total, including a screening period up to 4 weeks, a 48-week treatment period and 16-week post-washout follow-up period. For patients randomized earlier, they will continue on treatment at least until the last patient is treated for 48 weeks.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Multiple Sclerosis
Intervention
teriflunomide (HMR1726), interferon beta-1a
Location
Sanofi-Aventis Investigational Site Number 056003
Bruxelles
Belgium
1070
Status
Recruiting
Source
Sanofi-Aventis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00883337
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Multiple Sclerosis, Chronic Progressive
A form of multiple sclerosis characterized by a progressive deterioration in neurologic function which is in contrast to the more typical relapsing remitting form. If the clinical course is free of distinct remissions, it is referred to as primary progressive multiple sclerosis. When the progressive decline is punctuated by acute exacerbations, it is referred to as progressive relapsing multiple sclerosis. The term secondary progressive multiple sclerosis is used when relapsing remitting multiple sclerosis evolves into the chronic progressive form. (From Ann Neurol 1994;36 Suppl:S73-S79; Adams et al., Principles of Neurology, 6th ed, pp903-914)
Interferon Type I
Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).
Receptor, Interferon Alpha-beta
A ubiquitously expressed heterodimeric receptor that is specific for both INTERFERON-ALPHA and INTERFERON-BETA. It is composed of two subunits referred to as IFNAR1 and IFNAR2. The IFNAR2 subunit is believed to serve as the ligand-binding chain; however both chains are required for signal transduction. The interferon alpha-beta receptor signals through the action of JANUS KINASES such as the TYK2 KINASE.
Interferon Regulatory Factor-1
An interferon regulatory factor that binds upstream TRANSCRIPTIONAL REGULATORY ELEMENTS in the GENES for INTERFERON-ALPHA and INTERFERON-BETA. It functions as a transcriptional activator for the INTERFERON TYPE I genes.
Interferon Regulatory Factor-7
An interferon regulatory factor that is induced by INTERFERONS as well as LMP-1 protein from EPSTEIN-BARR VIRUS. IRF-7 undergoes PHOSPHORYLATION prior to nuclear translocation and it activates GENETIC TRANSCRIPTION of multiple interferon GENES.
Clinical Trials
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 conversio...
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 mul...
Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.
The purpose of this study is to determine the effects of teriflunomide on: frequency of relapses; accumulation of disability, measured by Expanded Disability Status Scale (EDSS); burden of...
The purpose of this study is to document the long-term safety as primary objective of teriflunomide 7mg or 14 mg in MS patients who participated to the efficacy study (EFC6049) double blin...
PubMed Articles
Teriflunomide added to interferon-β in relapsing multiple sclerosis: A randomized phase II trial.
OBJECTIVE: To evaluate teriflunomide as add-on therapy to ongoing stable-dosed interferon-β (IFNβ) in patients with relapsing forms of multiple sclerosis (RMS). METHODS: A total of 118 patients with...
Teriflunomide for treatment of multiple sclerosis.
Interferon beta and glatiramer acetate are still considered to be the first-line therapeutics for treatment of relapsing forms of multiple sclerosis (MS). The use of new compounds, such as natalizumab...
Interferon beta is widely prescribed to treat multiple sclerosis (MS); however, its relationship with disability progression has yet to be established.
Lymphocyte calcium influx kinetics in multiple sclerosis treated without or with interferon beta.
Kv1.3 and IKCa1 potassium channels play an important role in the maintenance of calcium-influx during lymphocyte activation and present a possible target for selective immunomodulation. We investigate...
