Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"
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|ClinicalTrials.gov Identifier: NCT03209479|
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : July 24, 2018
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Drug: Glatiramer acetate|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"|
|Actual Study Start Date :||November 24, 2015|
|Estimated Primary Completion Date :||March 31, 2025|
|Estimated Study Completion Date :||March 31, 2025|
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.
Drug: Glatiramer acetate
Copaxone subcutaneous injection syringe
Other Name: Copaxone subcutaneous injection syringe
- Percentage of participants who had one or more adverse events [ Time Frame: Up to 24 months ]
- 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.
- Changes in the number of lesions from brain MRI findings [ Time Frame: Up to 24 months ]
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209479
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
|Takeda selected site||Recruiting|
|Study Chair:||Postmarketing Group Manager||Takeda|