An observational study in Multiple Sclerosis, sponsored by Teva Takeda Pharma Ltd.. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by Teva Takeda Pharma Ltd. · Observational
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.
This multi-center trial will be conducted in Japan.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 1,332 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →This is the only study on the registry with Teva Takeda Pharma Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The study population will consist of all participants with a diagnosis of multiple sclerosis and received their first dose of Copaxone/glatiramer acetate.
Exclusion Criteria:
-None
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
Also known as: Copaxone subcutaneous injection syringe
Percentage of participants who had one or more adverse events
Time frame: Up to 24 months
Annual Relapse Rate (ARR)
The annual relapse rate (ARR) after the start of treatment will be calculated throughout study.
Time frame: Up to 24 months
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])
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.
Time frame: 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.
Time frame: Up to 24 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.