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Methods for treating progressive multiple sclerosis

a progressive multiple sclerosis and treatment method technology, applied in the field of progressive multiple sclerosis treatment, can solve the problems of reducing known beneficial treatments, and the treatment approach based on this theory, and not fully preventing the occurrence of exacerbation or accumulation of disability

Inactive Publication Date: 2010-06-24
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0025]In some embodiments, the treatment reduces the time to confirmed disease progression. In some embodiments, the confirmed disease progression is an increase in EDSS that is sustained for twelve weeks. In some embodiments, the confirmed disease progression is an increase in EDSS that is sustained for twenty-four weeks.
[0033]In some embodiments, the treatment reduces the time to confirmed disease progression. In some embodiments, the confirmed disease progression is an increase in EDSS that is sustained for twelve weeks. In some embodiments, the confirmed disease progression is an increase in EDSS that is sustained for twenty-four weeks.
[0041]In some embodiments, the treatment reduces the time to confirmed disease progression. In some embodiments, the confirmed disease progression is an increase in EDSS that is sustained for twelve weeks. In some embodiments, the confirmed disease progression is an increase in EDSS that is sustained for twenty-four weeks.

Problems solved by technology

MS is a major cause of neurologic disability in young and middle-aged adults and, until the past decade, has had no known beneficial treatments.
Therapeutic approaches based on this theory such as IFN-beta and glatiramer acetate decrease, but do not fully prevent, occurrence of exacerbations or accumulation of disability.

Method used

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  • Methods for treating progressive multiple sclerosis
  • Methods for treating progressive multiple sclerosis
  • Methods for treating progressive multiple sclerosis

Examples

Experimental program
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Effect test

example 1

A Phase II Study of Ocrelizumab in Relapsing-Remitting Multiple Sclerosis (RRMS)

[0365]A phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy as measured by brain Magnetic Resonance Imaging (MRI) lesions, and safety of two dose regimens of ocrelizumab in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) is performed.

[0366]The two ocrelizumab dose regimens under investigation are as follows: 1) ocrelizumab 1000 mg dose regimen: consisting of a dual infusion of 1000 mg for the first treatment cycle followed by single infusions of 1000 mg for the subsequent treatment cycles and 2) ocrelizumab 600 mg dose regimen: consisting of a dual infusion of 300 mg for the first treatment cycle followed by single infusions of 600 mg for the subsequent treatment cycles.

[0367]Eligible patients are randomized (1:1:1:1) into one of four treatment groups A, B, C or D as described in FIG. 7. The overview o...

example 2

A Phase II / III Study of Rituximab in Primary Progressive Multiple Sclerosis (PPMS)

[0400]A randomized, double-blind, parallel group, placebo controlled, multicenter Phase II / III study (U2786g) to evaluate the safety and efficacy of rituximab in adults with Primary Progressive Multiple Sclerosis (PPMS) as defined by McDonald et al (Ann Neurol 50:121-7 (2001)) was performed.

[0401]Subjects were randomized in a 2:1 ratio to receive either rituximab or placebo. Rituximab, commercially available from Genentech, was formulated for i.v. administration as a sterile product in 9.0 mg / ml sodium chloride, 0.7 mg / ml polysorbate 80, 7.35 mg / ml sodium citrate dehydrate, and sterile water for injection (pH 6.5). Each course of study drug consisted of two i.v. infusions (separated by 14 days) of 1000 mg rituximab or placebo. Subjects received the first course of treatment at Days 1 and 15 and received additional courses at Weeks 24, 48, and 72. Subjects received acetaminophen (1 g) and diphenhydramin...

example 3

A Phase III Study of Ocrelizumab in Progressive Multiple Sclerosis

[0415]A Phase III, randomized, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of 600 mg of ocrelizumab as compared with placebo in adults with progressive MS is performed.

[0416]A total of 630 progressive MS patients (315 with progressive onset and 315 with relapsing onset MS) are enrolled and assigned (2:1 randomization) to either ocrelizumab arm or placebo arm stratified by site and type of multiple sclerosis. This study consists of the following three periods that apply to all patients: a screening period, a treatment period and a treatment free follow up period. In the first course of study drug treatment (300 mg ocrelizumab or placebo infusion×2) are administered on Days 1 and 15. In subsequent treatment courses, patients are dosed (600 mg ocrelizumab single infusion) every 24 weeks until the last patient enrolled receives his / her last course of treatment to be administered at ...

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Abstract

The present invention concerns methods for treating progressive multiple sclerosis (MS) in a patient, and an article of manufacture with instructions for such use.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority benefit to U.S. Provisional Application Ser. No. 61 / 097,464, filed Sep. 16, 2008, the entirety of which is hereby incorporated by reference.FIELD OF THE INVENTION[0002]The present invention concerns methods for treating progressive multiple sclerosis (MS) in a patient, and an article of manufacture with instructions for such use.BACKGROUND OF THE INVENTIONMultiple Sclerosis[0003]Multiple Sclerosis (MS) is an inflammatory and demyelinating degenerative disease of the human central nervous system (CNS). It is a worldwide disease that affects approximately 300,000 persons in the United States; it is a disease of young adults, with 70%-80% having onset between 20 and 40 years old (Anderson et al. Ann Neurology 31(3):333-6 (1992); Noonan et al. Neurology 58:136-8 (2002)). MS is a heterogeneous disorder based on clinical course, magnetic resonance imaging (MRI) scan assessment, and pathology analysis of biopsy a...

Claims

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Application Information

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IPC IPC(8): A61K39/395G06Q90/00
CPCA61K39/00A61K2039/505A61K2039/545G06Q99/00C07K16/2887C07K2317/24C07K2317/76A61K2039/55A61B5/055A61K9/0019A61K39/3955A61K45/06A61K2039/507C07K2317/565G01N33/686G01N2800/52G01N2800/7095A61P25/00A61P25/28A61P29/00A61P37/00A61P37/02A61P37/06
Inventor SMITH, CRAIGCHIN, PETER S.
Owner F HOFFMANN LA ROCHE & CO AG
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