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Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients

NCT ID: NCT01167426

Last Updated: 2013-10-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-12-31

Brief Summary

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This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.

Detailed Description

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The study will consist of a 2 week treatment period with participants injecting their current therapy of Copaxone 20 mg/1.0 mL glatiramer acetate utilizing an autoject 2. All participants will then roll over to the new formulation of 20 mg/0.5 mL glatiramer acetate with an autoject 2 device for a 4 week treatment period. Patient satisfaction will be evaluated using an Experience Questionnaire throughout the study.

Conditions

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Multiple Sclerosis

Keywords

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Relapsing Remitting Multiple Sclerosis RRMS Clinically Isolated Syndrome CIS Copaxone glatiramer acetate Autoject 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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20 mg/0.5 mL Glatiramer Acetate

Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).

Group Type ACTIVE_COMPARATOR

Glatiramer Acetate 20 mg/0.5 mL

Intervention Type DRUG

20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe.

Glatiramer acetate 20 mg/0.5 mL

Intervention Type DRUG

20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device.

Interventions

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Glatiramer Acetate 20 mg/0.5 mL

20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe.

Intervention Type DRUG

Glatiramer acetate 20 mg/0.5 mL

20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device.

Intervention Type DRUG

Other Intervention Names

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Copaxone®

Eligibility Criteria

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Inclusion Criteria

* Patients ≥ 18 years of age with a diagnosis of Relapse Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS)
* Currently injecting glatiramer acetate 20 mg/1.0 mL per day subcutaneously (SC) for a minimum of 90 days utilizing the autoject 2 for glass syringe for a minimum of 75% of daily injections
* Willing and able to complete all procedures and evaluations related to the study
* Willing to continue to follow usual injection site preparation and routine adjunctive local injection site reactions (LISR) management techniques
* Willing and able to provide written informed consent

Exclusion Criteria

* Currently using or treated with another immunomodulating therapy (IMT) in conjunction with GA in the 30 days prior to screening for this study
* Currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study
* Pregnant or planning pregnancy or breastfeeding
* Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.) either currently or in the past 30 days prior to screening for this study
* Any other medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the Investigator
* Unwilling to perform all daily injections with an autoject 2 device
* Previous participation in any study evaluating the new 20 mg/0.5 mL formulation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Neuroscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tom Smith, MD

Role: STUDY_DIRECTOR

Teva Neuroscience, Inc.

Countries

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United States

Other Identifiers

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PM034

Identifier Type: -

Identifier Source: org_study_id