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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
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date July 4, 2017
First Posted Date July 6, 2017
Last Update Posted Date July 24, 2018
Actual Study Start Date November 24, 2015
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2017)
  • 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03209479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 4, 2017)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"
Official Title Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population will consist of all participants with a diagnosis of multiple sclerosis and received their first dose of Copaxone/glatiramer acetate.
Condition Multiple Sclerosis
Intervention Drug: Glatiramer acetate
Copaxone subcutaneous injection syringe
Other Name: Copaxone subcutaneous injection syringe
Study Groups/Cohorts 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.
Intervention: Drug: Glatiramer acetate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 4, 2017)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2025
Estimated Primary Completion Date March 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients treated with Copaxone from the first day of market launch of the product

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03209479
Other Study ID Numbers Glatiramer-5001
JapicCTI-153058 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Takeda
Study Sponsor Takeda
Collaborators Not Provided
Investigators
Study Chair: Postmarketing Group Manager Takeda
PRS Account Takeda
Verification Date July 2018