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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Glatiramer acetate

• Registration Number: NCT03209479
• Lead Sponsor: Teva Takeda Pharma Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-11-24
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-06
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1332

Inclusion Criteria

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

Exclusion Criteria

-None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glatiramer acetate	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.

Primary Outcome Measures

Name	Time	Method
Annual Relapse Rate (ARR)	Up to 24 months	The annual relapse rate (ARR) after the start of treatment will be calculated throughout study.
Percentage of participants who had one or more adverse events	Up to 24 months

Secondary Outcome Measures

Name	Time	Method
Changes in functional evaluation scores (Functional Systems [FS])	Up to 24 months	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.
Changes in functional evaluation scores (Expanded Disability Status Scale [EDSS])	Up to 24 months	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.
Changes in the number of lesions from brain MRI findings	Up to 24 months

Trial Locations

Locations (1)

Takeda selected site; 🇯🇵 Tokyo, Japan