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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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
Relapsing Remitting Multiple Sclerosis
Natalizumab, Interferon B-1a, Glatiramer acetate, Natalizumab
Published on BioPortfolio: 2014-08-27T03:16:20-0400
The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-r...
The purpose of this study it to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab (during the first 48 weeks) and assess the long-term efficacy of nataliz...
Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young adults. The management of MS-patients requires treatment with disease-modifying agents, monoclo...
The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple...
A prospective clinical trial with the aim of maintaining drug efficacy of natalizumab while extending dose intervals guided by drug concentrations in patients with relapsing remitting mult...
Natalizumab is the first targeted humanized monoclonal antibody to be approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). Natalizumab appears to be more effective than current...
The aim of this study was to evaluate the safety, tolerability, and efficacy of a brand-generic glatiramer acetate product in patients with relapsing-remitting multiple sclerosis over a 12-month perio...
Delayed-release dimethyl fumarate (DMF) may be a therapeutic option for patients with relapsing-remitting multiple sclerosis (RRMS) who are treated with natalizumab and require a change in therapy. Ho...
Natalizumab is administered for the treatment of relapsing-remitting multiple sclerosis (RR-MS) with high disease activity.Natalizumab therapy has been associated with adverse effects, such as progres...
Probably no other disease-modifying drug for multiple sclerosis has a more fascinating story than natalizumab from both the bench to bedside perspective and the postmarketing experience standpoint. Na...
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.
Spinal Cord Disorders
The spinal cord is a bundle of nerves that runs down the middle of the back which carry signals back and forth between the body and brain. It is protected by vertebrae, which are the bone disks that make up the spine. An accident that damages the verte...
Radiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...