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Observational Study to Determine Impact of Multiple NAb Tests on Treatment Patterns Compared to the Usual Care of MS Patients Receiving High-Dose IFN Therapy

2014-08-27 03:44:12 | BioPortfolio

Summary

An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.

Description

Randomized, controlled, open-label parallel group study. All high-dose IFN patients willing to consent will be given a Binding Antibody (BAb) test and if it is positive (>4 units), a Neutralizing Antibody (NAb) test will also be done. Patients will be randomized to one of two arms:

Regularly Scheduled Nab Testing Arm: Patients will be followed-up for 12 months. At least 2 NAb and BAb tests will be performed during the study.

Usual Care Arm: Patients will be followed-up for 12 months under usual care conditions.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Conditions

Multiple Sclerosis

Intervention

NAbs testing

Location

Phoenix Neurological Associates, LTD
Phoenix
Arizona
United States
85006

Status

Active, not recruiting

Source

Teva Pharmaceutical Industries

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:12-0400

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Medical and Biotech [MESH] Definitions

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)

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.

An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903)

The most common clinical variant of MULTIPLE SCLEROSIS, characterized by recurrent acute exacerbations of neurologic dysfunction followed by partial or complete recovery. Common clinical manifestations include loss of visual (see OPTIC NEURITIS), motor, sensory, or bladder function. Acute episodes of demyelination may occur at any site in the central nervous system, and commonly involve the optic nerves, spinal cord, brain stem, and cerebellum. (Adams et al., Principles of Neurology, 6th ed, pp903-914)

Multiple protein bands serving as markers of specific ANTIBODIES and detected by ELECTROPHORESIS of CEREBROSPINAL FLUID or serum. The bands are most often seen during inflammatory or immune processes and are found in most patients with MULTIPLE SCLEROSIS.

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