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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT1080223004 | Registry Identifier | jRCT |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glatiramer acetate | Drug | Copaxone subcutaneous injection syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who had one or more adverse events | Up to 24 months | |
| Annual Relapse Rate (ARR) | The annual relapse rate (ARR) after the start of treatment will be calculated throughout study. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the number of lesions from brain MRI findings | Up to 24 months | |
| 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. |
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Inclusion Criteria:
- All patients treated with Copaxone from the first day of market launch of the product
Exclusion Criteria:
-None
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The study population will consist of all participants with a diagnosis of multiple sclerosis and received their first dose of Copaxone/glatiramer acetate.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda (Note: This product was divested to Teva Takeda Pharma Ltd. in 2024.) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda selected site | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Up to 24 months |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |