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Application of combination of cladribine and glatirameracetate in treating multiple sclerosis

A technology of glatiramer acetate and multiple sclerosis, which is applied in the direction of drug combinations, medical preparations containing active ingredients, organic active ingredients, etc., and can solve the undisclosed problems of effectiveness and safety in the treatment of multiple sclerosis

Inactive Publication Date: 2014-06-11
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the above patent discloses that cladribine may be combined with other compounds known to be effective in the treatment of multiple sclerosis for the treatment of the disease, however, no specific combination exhibiting said efficacy and safety for the treatment of multiple sclerosis has been disclosed

Method used

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Embodiment 1

[0054] Placebo-controlled randomized double-blind study in relapsing-remitting multiple sclerosis patients concomitant with pharmaceutically effective doses of glatiramer acetate. The subcutaneous dose of glatiramer acetate is 20 mg per day.

[0055] Approximately 50 patients were treated in each treatment group (placebo group: 51, cladribine group: 52). Demographic and baseline disease characteristics were essentially comparable in the 2 treatment groups. The mean age of the study population was 41.4 years. Most patients were women (78.9%) with relapsing-remitting MS (94.3%) who had been diagnosed with MS since about 8 years ago and about 41% had no relapse in the previous year. Baseline Expanded Disability Status Scale scores were similar (approximately 2.5) between treatment groups. 28.6% of patients in the cladribine group had magnetic resonance imaging (MRI) disease activity (at least one T1-Gd lesion) at baseline, slightly more than those in the placebo group (24.6%)....

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Abstract

The invention relates to a method of treating relapsing-remitting multiple sclerosis by combining multi-dose cladribine and glatirameracetate for a needed patient.

Description

field of invention [0001] The present invention relates to a method of treating relapsing-remitting multiple sclerosis using multiple doses of cladribine in combination with glatiramer acetate for patients in need. Background technique [0002] Multiple sclerosis (MS) is a debilitating inflammatory neurological disease characterized by demyelination of the central nervous system. The disease mainly affects young adults and occurs more frequently in women. Symptoms of the disease include fatigue, numbness, tremors, tingling, dysesthesia, visual disturbances, vertigo, cognitive impairment, urinary disturbances, decreased mobility, and depression. Clinically, the disease is divided into four categories: relapsing-remitting, secondary progressive, primary-progressive and progressive-relapsing. [0003] The exact etiology of MS is unknown, however, it is strongly suspected that the demyelinating features of the disease are caused by an autoimmune response, possibly triggered by...

Claims

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Application Information

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IPC IPC(8): A61K38/16A61P25/00A61K31/7076
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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