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

NCT ID: NCT03209479

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1332 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-24

Study Completion Date

2024-03-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Glatiramer acetate

Intervention Type DRUG

Copaxone subcutaneous injection syringe

Interventions

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Glatiramer acetate

Copaxone subcutaneous injection syringe

Intervention Type DRUG

Other Intervention Names

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Copaxone subcutaneous injection syringe

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

-None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Takeda Pharma Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda (Note: This product was divested to Teva Takeda Pharma Ltd. in 2024.)

Locations

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Takeda selected site

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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https://clinicaltrials.takeda.com/study-detail/5f6b60234db2bf003ab49722

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

Other Identifiers

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jRCT1080223004

Identifier Type: REGISTRY

Identifier Source: secondary_id

Glatiramer-5001

Identifier Type: -

Identifier Source: org_study_id

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