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An Observational Study of Multiple Sclerosis (MS) Patients Starting or Restarting Baseline Treatment With Interferon Beta 1a After the Use of Escalation Treatment With Mitoxantrone

2014-08-27 03:12:57 | BioPortfolio

Summary

This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study to investigate whether baseline treatment with high-dose interferon beta 1a (Rebif 44 μg x 3 ), administered at a high frequency, leads to maintenance of stabilisation of the course of the disease in MS subjects previously treated with mitoxantrone. The previous mitoxantrone treatment of the included MS subjects was conducted in the course of a so-called escalation according to the immunomodulatory escalation treatment plan. An additional important aspect of the problem was the collection of safety and tolerance data during the observation phase.

Description

The treatment of relapsing-remitting MS with interferon-beta has established itself as first-choice treatment. In previous clinical studies, the interferon-beta 1a (Rebif) used within the scope of this PMS study has demonstrated significant efficacy in all aspects of treatment - magnetic resonance imaging (MRI) data, relapse rate, progression of disability of MS. The PRISMS-4 study demonstrated that treatment with Rebif reduces the frequency and severity of clinical relapses over 4 years and slows the progression of disability.

In the course of treatment escalation according to the Multiple Sklerose Therapie Konsensus Gruppe (MSTKG) guidelines, MS subjects with correspondingly high disease activity were predominantly put on mitoxantrone. The duration of treatment is on principle limited by a cumulative lifelong total dose of 140 mg/m2 body surface area, which may not be exceeded due to the known cardiologic adverse effects. If the cumulative mitoxantrone maximum dose is reached and if the subject is in a stable condition, the question of further treatment options presents itself. One possibility is the so-called 'deescalation', that is, the return to immunomodulating baseline treatment.

Currently there is an increasing number of subjects who are in this phase of the disease and are eligible for corresponding treatment decisions.

OBJECTIVES

Primary objective:

- To systematically investigate the safety, benefit and course of Rebif (44 μg x 3 ),treatment in a larger number of subjects and to subject these data to standardized analysis

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Conditions

Relapsing-Remitting Multiple Sclerosis

Intervention

Interferon beta 1a

Status

Completed

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:57-0400

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Medical and Biotech [MESH] Definitions

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.

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.

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)

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