Multiple Sclerosis
Conditions
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.
Interventions
DRUGGlatiramer acetate
Copaxone subcutaneous injection syringe
Sponsors
Teva Takeda Pharma Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- All patients treated with Copaxone from the first day of market launch of the product
Exclusion criteria
-None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who had one or more adverse events | Up to 24 months | — |
| Annual Relapse Rate (ARR) | Up to 24 months | The annual relapse rate (ARR) after the start of treatment will be calculated throughout study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the number of lesions from brain MRI findings | Up to 24 months | — |
| 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 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. |
Countries
Japan
Outcome results
None listed