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

IDENTIFIERS
Trial Protocol: Glatiramer-5001
Clinicaltrials.gov: NCT03209479
JapicCTI: JapicCTI-153058
PURPOSE

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.

Recruiting
JP

Trial at a glance

What medical condition is being studied?   Multiple Sclerosis (MS)
What is the trial testing?   Glatiramer acetate
How many participants are being enrolled?   1000
When is the trial being conducted?    - 

Key requirements

Sex   
All
Age   
All
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Type:   Observational
Trial Arms/Groups or Cohorts:   
Glatiramer acetate: For adults, a 20 mg dose of glatiramer acetate will be subcutaneously administered once daily. Participants will receive interventions as part of routine medical care.
Intervention:   Glatiramer acetate
Primary Outcome Measure(s):   
Percentage of participants who had one or more adverse events [Time Frame: Up to 24 months]
Annual Relapse Rate (ARR) [Time Frame: Up to 24 months]
Secondary Outcome Measure(s):   
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]) [Time Frame: Up to 24 months]
Changes in functional evaluation scores (Functional Systems [FS]) [Time Frame: Up to 24 months]
Entry Criteria:
Inclusion Criteria: - All patients treated with Copaxone from the first day of market launch of the product Exclusion Criteria: - None

Trial Locations

Any
Recruiting
Any
RESULTS
Takeda selected site

Tokyo, Japan

Recruiting
6,707 miles (10,793 km)  awayfrom
Boston, Massachusetts
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Trial Protocol ID: Glatiramer-5001
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