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

Teva Takeda Pharma Ltd.

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Glatiramer acetate

Study type: Observational

Funder types: Industry

Identifiers

NCT03209479

Glatiramer-5001

jRCT1080223004 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,332 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

-None

Trial design

1,332 participants in 1 patient group

Glatiramer acetate

Description:

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.

Treatment:

Drug: Glatiramer acetate