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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

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.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Glatiramer acetate

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.


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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Drug: Glatiramer acetate
Copaxone subcutaneous injection syringe
Other Name: Copaxone subcutaneous injection syringe




Primary Outcome Measures :
  1. Percentage of participants who had one or more adverse events [ Time Frame: Up to 24 months ]
  2. 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.


Secondary Outcome Measures :
  1. Changes in the number of lesions from brain MRI findings [ Time Frame: Up to 24 months ]
  2. 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.

  3. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
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Japan
Takeda selected site Recruiting
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Chair: Postmarketing Group Manager Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03209479     History of Changes
Other Study ID Numbers: Glatiramer-5001
JapicCTI-153058 ( Registry Identifier: JapicCTI )
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Glatiramer Acetate
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents