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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209479
• Other study ID #: Glatiramer-5001
• Secondary ID: jRCT1080223004
• Status: Completed
• Start date: November 24, 2015
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2024
• Source: Teva Takeda Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1332
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients treated with Copaxone from the first day of market launch of the product

Exclusion Criteria:

-None

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Glatiramer acetate
Copaxone subcutaneous injection syringe

Locations

Country	Name	City	State
Japan	Takeda selected site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Teva Takeda Pharma Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who had one or more adverse events		Up to 24 months
Primary	Annual Relapse Rate (ARR)	The annual relapse rate (ARR) after the start of treatment will be calculated throughout study.	Up to 24 months
Secondary	Changes in the number of lesions from brain MRI findings		Up to 24 months
Secondary	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.	Up to 24 months
Secondary	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.	Up to 24 months

External Links

•   To obtain more information on the study, click here/on this link