Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis
| Status: | Archived |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2010 |
| End Date: | May 2013 |
A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active-Controlled Study to Evaluate the Effects of Switching Therapy (Glatiramer Acetate or Interferon β-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple Sclerosis
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.
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.
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