Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"

N/ACompletedNCT03209479

Teva Takeda Pharma Ltd.1,332 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of Copaxone subcutaneous injection syringe (hereinafter referred to as Copaxone) in patients with multiple sclerosis in the routine clinical setting.

The drug being tested in this study is called Glatiramer acetate is being tested to treat people who have Multiple sclerosis. This study will look at the safety and efficacy of Glatiramer acetate in patients with multiple sclerosis in the routine clinical setting. The study will enroll approximately 1000 patients. • Glatiramer acetate subcutaneous injection syringe This multi-center trial will be conducted in Japan.

Study Type

OBSERVATIONAL

Enrollment

1,332

Conditions

Multiple Sclerosis

Interventions

Glatiramer acetateDRUG

Copaxone subcutaneous injection syringe

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: \- All patients treated with Copaxone from the first day of market launch of the product Exclusion Criteria: -None

Locations (1)

Takeda selected site

Tokyo, Japan

Outcomes

Primary Outcomes

Percentage of participants who had one or more adverse events

Time frame: Up to 24 months

Annual Relapse Rate (ARR)

The annual relapse rate (ARR) after the start of treatment will be calculated throughout study.

Time frame: Up to 24 months

Secondary Outcomes

Changes in the number of lesions from brain MRI findings

Time frame: Up to 24 months

Changes in functional evaluation scores (Expanded Disability Status Scale [EDSS])

EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. EDSS scale ranges from 0 to 10 in 0.5 unit increments and higher score refers to people with higher levels of disability by multiple sclerosis.

Time frame: Up to 24 months

Changes in functional evaluation scores (Functional Systems [FS])

FS is based on a standard neurological examination; the 7 functional systems plus "other" (Pyramidal, Cerebellar, Brainstem, Sensory, Bowel and bladder function, Visual function, Cerebral \[or mental\] functions, other) are rated. Each FS is scored on a scale of 0 (no disability) to 5 or 6 (more severe disability), and total score ranging from 0 to 40. Higher score in each functional system refers to people with higher levels of disability by multiple sclerosis.

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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