Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"
2 other identifiers
observational
1,332
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 24, 2015
CompletedFirst Submitted
Initial submission to the registry
July 4, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedJune 13, 2024
June 1, 2024
8.4 years
July 4, 2017
June 11, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
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
Changes in functional evaluation scores (Functional Systems [FS])
Up to 24 months
Study Arms (1)
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.
Interventions
Copaxone subcutaneous injection syringe
Eligibility Criteria
The study population will consist of all participants with a diagnosis of multiple sclerosis and received their first dose of Copaxone/glatiramer acetate.
You may qualify if:
- \- All patients treated with Copaxone from the first day of market launch of the product
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Takeda selected site
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda (Note: This product was divested to Teva Takeda Pharma Ltd. in 2024.)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2017
First Posted
July 6, 2017
Study Start
November 24, 2015
Primary Completion
March 31, 2024
Study Completion
March 31, 2024
Last Updated
June 13, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- 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.
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.