Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®



Status:Completed
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:10/18/2018
Start Date:August 10, 2015
End Date:June 2, 2017

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CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily

The primary objective of this study is to compare patient medication satisfaction as measured
by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three
time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of
treatment.


Inclusion Criteria:

1. Men or women at least 18 years of age or older.

2. Patients must have a confirmed and documented RRMS diagnosis

3. Patients must be ambulatory with a Kurtzke EDSS score of 0 to 5.5 at screening visit.

4. Patients must be in a stable neurological condition, relapse-free and free of any
corticosteroid treatment 30 days prior to randomization.

5. Women of child-bearing potential must have a negative urine pregnancy test at
screening visit and must practice an acceptable method of birth

6. Patients must be able to sign and date a written informed consent prior to entering
the study.

7. Patients must be willing and able to comply with the protocol requirements for the
duration of the study.

Exclusion Criteria

1. Patient had any contraindication to Copaxone therapy.

2. Previous use of Copaxone 40 mg/mL three times per week.

3. Patients with progressive forms of MS.

4. Patients with neuromyelitis optica.

5. Use of experimental or investigational drugs, and/or participation in drug clinical
studies within the 6 months prior to screening.

6. Patients who have been treated with; immunosuppressive medications, immunoglobulins
and/or monoclonal antibodies, alemtuzumab, cladribine, cyclophosphamide or
mitoxantrone at any time

7. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid
treatment within 6 months prior to screening visit.

8. Pregnancy or breastfeeding.

9. Clinically significant or unstable medical or surgical condition that would preclude
safe and complete study participation

10. Employees of the clinical study site or any other individuals involved with the
conduct of the study, or immediate family members of such individuals

- other criteria may apply, please contact the investigator for more information
We found this trial at
16
sites
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Buenos Aires,
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Atlanta, GA
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Carmichael, California
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Carmichael, CA
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Columbus, Ohio
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Columbus, OH
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Cullman, AL
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Foxboro, Massachusetts 02035
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Foxboro, MA
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Golden Valley, Minnesota
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Golden Valley, MN
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Golden Valley, Minnesota
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Golden Valley, MN
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Las Vegas, Nevada
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Las Vegas, NV
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New Hyde Park, New York
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New Hyde Park, NY
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Northbrook, Illinois
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Northbrook, IL
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Raleigh, North Carolina
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Raleigh, NC
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Round Rock, Texas
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Round Rock, TX
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Teaneck, New Jersey
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Teaneck, NJ
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from
Uniontown, OH
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Virginia Beach, Virginia
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from
Virginia Beach, VA
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