Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®
NCT ID: NCT02499900
Last Updated: 2021-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
861 participants
INTERVENTIONAL
2015-08-10
2017-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Copaxone® 40 mg/mL
Subcutaneous Injections 40 mg/mL Three Times a Week for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.
Copaxone®
Subcutaneous Injections
Copaxone® 20 mg/mL
Subcutaneous Injections 20 mg/mL Daily for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.
Copaxone®
Subcutaneous Injections
Interventions
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Copaxone®
Subcutaneous Injections
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 13485
Cullman, Alabama, United States
Teva Investigational Site 13524
Carmichael, California, United States
Teva Investigational Site 13478
Atlanta, Georgia, United States
Teva Investigational Site 13475
Northbrook, Illinois, United States
Teva Investigational Site 13472
Foxborough, Massachusetts, United States
Teva Investigational Site 13479
Golden Valley, Minnesota, United States
Teva Investigational Site 13483
Golden Valley, Minnesota, United States
Teva Investigational Site 13487
Las Vegas, Nevada, United States
Teva Investigational Site 13470
Teaneck, New Jersey, United States
Teva Investigational Site 13482
New Hyde Park, New York, United States
Teva Investigational Site 13471
Raleigh, North Carolina, United States
Teva Investigational Site 13473
Columbus, Ohio, United States
Teva Investigational Site 13477
Uniontown, Ohio, United States
Teva Investigational Site 13481
Round Rock, Texas, United States
Teva Investigational Site 13480
Virginia Beach, Virginia, United States
Teva Investigational Site 20061
Buenos Aires, , Argentina
Teva Investigational Site 20062
Buenos Aires, , Argentina
Teva Investigational Site 20063
Rosario, , Argentina
Teva Investigational Site 33040
Vienna, , Austria
Teva Investigational Site 37066
Brussels, , Belgium
Teva Investigational Site 37063
Edegem, , Belgium
Teva Investigational Site 60037
Rijeka, , Croatia
Teva Investigational Site 60039
Slavonski Brod, , Croatia
Teva Investigational Site 60034
Zagreb, , Croatia
Teva Investigational Site 60035
Zagreb, , Croatia
Teva Investigational Site 60036
Zagreb, , Croatia
Teva Investigational Site 60040
Zagreb, , Croatia
Teva Investigational Site 40014
Tampere, , Finland
Teva Investigational Site 40015
Turku, , Finland
Teva Investigational Site 35211
Besançon, , France
Teva Investigational Site 35203
Bordeaux, , France
Teva Investigational Site 35207
Bron, , France
Teva Investigational Site 35210
Clermont-Ferrand, , France
Teva Investigational Site 35208
Lille, , France
Teva Investigational Site 35214
Lomme, , France
Teva Investigational Site 35204
Nancy, , France
Teva Investigational Site 35205
Nice, , France
Teva Investigational Site 35206
Nîmes, , France
Teva Investigational Site 35212
Nîmes, , France
Teva Investigational Site 35213
Poissy, , France
Teva Investigational Site 35202
Rennes, , France
Teva Investigational Site 35201
Strasbourg, , France
Teva Investigational Site 35209
Toulouse, , France
Teva Investigational Site 32605
Bayreuth, , Germany
Teva Investigational Site 32603
Dresden, , Germany
Teva Investigational Site 32602
Hamburg, , Germany
Teva Investigational Site 32606
Rostock, , Germany
Teva Investigational Site 32604
Stuttgart, , Germany
Teva Investigational Site 44029
Dublin, , Ireland
Teva Investigational Site 30169
Bari, , Italy
Teva Investigational Site 30163
Genova, , Italy
Teva Investigational Site 30165
Milan, , Italy
Teva Investigational Site 30164
Milan, , Italy
Teva Investigational Site 30161
Montichiari, , Italy
Teva Investigational Site 30167
Naples, , Italy
Teva Investigational Site 30166
Rome, , Italy
Teva Investigational Site 30162
Rome, , Italy
Teva Investigational Site 21096
DF, , Mexico
Teva Investigational Site 21097
Mexico City, , Mexico
Teva Investigational Site 21095
Mexico City, , Mexico
Teva Investigational Site 21098
Mexico City, , Mexico
Teva Investigational Site 53352
Bydgoszcz, , Poland
Teva Investigational Site 53354
Gdansk, , Poland
Teva Investigational Site 53353
Gmina Końskie, , Poland
Teva Investigational Site 53350
Katowice, , Poland
Teva Investigational Site 53349
Kielce, , Poland
Teva Investigational Site 53356
Lodz, , Poland
Teva Investigational Site 53348
Lodz, , Poland
Teva Investigational Site 53345
Lublin, , Poland
Teva Investigational Site 53355
Olsztyn, , Poland
Teva Investigational Site 53351
Rybnik, , Poland
Teva Investigational Site 53347
Rzeszów, , Poland
Teva Investigational Site 53346
Warsaw, , Poland
Teva Investigational Site 13476
Guaynabo, , Puerto Rico
Teva Investigational Site 50392
Kaluga, , Russia
Teva Investigational Site 50390
Kazan', , Russia
Teva Investigational Site 50391
Krasnoyarsk, , Russia
Teva Investigational Site 50387
Moscow, , Russia
Teva Investigational Site 50374
Moscow, , Russia
Teva Investigational Site 50373
Moscow, , Russia
Teva Investigational Site 50376
Novosibirsk, , Russia
Teva Investigational Site 50389
Perm, , Russia
Teva Investigational Site 50377
Saint Petersburg, , Russia
Teva Investigational Site 50375
Saint Petersburg, , Russia
Teva Investigational Site 50372
Tyumen, , Russia
Teva Investigational Site 50378
Yaroslavl, , Russia
Teva Investigational Site 31181
Burgos, , Spain
Teva Investigational Site 31179
El Palmar, , Spain
Teva Investigational Site 31180
Madrid, , Spain
Teva Investigational Site 31177
Málaga, , Spain
Teva Investigational Site 31182
Seville, , Spain
Teva Investigational Site 31184
Seville, , Spain
Teva Investigational Site 31178
Valencia, , Spain
Teva Investigational Site 82052
Ankara, , Turkey (Türkiye)
Teva Investigational Site 82051
Istanbul, , Turkey (Türkiye)
Teva Investigational Site 82049
Istanbul, , Turkey (Türkiye)
Teva Investigational Site 82050
Kocaeli, , Turkey (Türkiye)
Countries
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References
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Cutter G, Veneziano A, Grinspan A, Al-Banna M, Boyko A, Zakharova M, Maida E, Pasic MB, Gandhi SK, Everts R, Cordioli C, Rossi S. Higher satisfaction and adherence with glatiramer acetate 40 mg/mL TIW vs 20 mg/mL QD in RRMS. Mult Scler Relat Disord. 2019 Aug;33:13-21. doi: 10.1016/j.msard.2019.04.036. Epub 2019 May 9.
Other Identifiers
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2015-000922-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TV44400-CNS-40083
Identifier Type: -
Identifier Source: org_study_id