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Completed

NCT Number: NCT03209479

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda selected site

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-None

Treatment and study plan

Glatiramer Acetate

Drug

Copaxone subcutaneous injection syringe

Other names: Copaxone subcutaneous injection syringe

Primary outcomes

  1. Percentage of participants who had one or more adverse events

    Time frame: Up to 24 months

  2. Annual Relapse Rate (ARR)

    Time frame: Up to 24 months

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

Secondary outcomes

  1. Changes in the number of lesions from brain MRI findings

    Time frame: Up to 24 months

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Teva Takeda Pharma Ltd.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2017
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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