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Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

2014-08-27 03:16:20 | BioPortfolio

Summary

Current disease modifying treatments (DMTs) for multiple sclerosis (MS), including interferon β and glatiramer acetate, are only partially effective therapies as shown by the significant number of patients who continue to experience clinical and magnetic resonance imaging (MRI) disease activity despite treatment.

This study will examine subjects with relapsing-remitting MS that has been active within the past 12 months, that are being treated with either Copaxone® (glatiramer acetate) or Rebif® (interferon β-1a). This study aims to measure the effect of switching to Tysabri compared to receiving Copaxone (glatiramer acetate) or Rebif (interferon β-1a)in subjects with Relapsing Remitting Multiple Sclerosis. The results of clinical tests and evaluations and brain magnetic resonance imaging (MRI) scans will be compared.

Description

A patient with ongoing disease activity despite initial immunomodulatory treatment is faced with several options regarding their future treatment including: stopping, continuing, or switching treatments. There are currently no data from appropriately designed, well-controlled clinical studies to provide guidance on these choices. This study will rigorously evaluate three alternative algorithms for management of subjects with ongoing disease activity despite treatment in a well-controlled fashion. These data will provide physicians and patients clear and objective information about the relative benefits of different treatment options. The study also includes prospectively applied criteria for disease activity which include clinical and MRI measures believed to be predictive of poor response to a current therapy. If their predictive value is confirmed in this study, these findings would provide validation of these criteria and would be a significant advancement toward optimizing treatment in a high-risk MS patient population.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Conditions

Relapsing Remitting Multiple Sclerosis

Intervention

Natalizumab, Interferon B-1a, Glatiramer acetate, Natalizumab

Location

Research Site
Cullman
Alabama
United States
35058

Status

Recruiting

Source

Biogen Idec

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:20-0400

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Medical and Biotech [MESH] Definitions

A humanized monoclonal immunoglobulin G4 antibody to human INTEGRIN ALPHA4 that binds to the alpha4 subunit of INTEGRIN ALPHA4BETA1 and integrin alpha4beta7. It is used as an IMMUNOLOGIC FACTOR in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS and CROHN'S DISEASE.

A random polymer of L-ALANINE, L-GLUTAMIC ACID, L-LYSINE, and L-TYROSINE that structurally resembles MYELIN BASIC PROTEIN. It is used in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS.

A non-glycosylated form of interferon beta-1 that has a serine at position 17. It is used in the treatment of both RELAPSING-REMITTING MULTIPLE SCLEROSIS and CHRONIC PROGRESSIVE MULTIPLE SCLEROSIS.

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)

An interferon beta-1 subtype that has a methionine at position 1, a cysteine at position 17, and is glycosylated at position 80. It functions as an ANTI-VIRAL AGENT and IMMUNOMODULATOR and is used to manage the symptoms of RELAPSING-REMITTING MULTIPLE SCLEROSIS.

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