An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Interventions
- Drug: Placebo
- Registration Number
- NCT01578785
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).
- Detailed Description
Approximately 1400 participants were planned for this study, however only 178 were enrolled prior to early termination.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 178
Subjects must meet all inclusion criteria in order to be eligible for the study:
- Subjects must have a confirmed and documented multiple sclerosis (MS) diagnosis as defined by the 2010 Revised McDonald criteria [Ann Neurol 2011: 69:292-302], with a relapsing-remitting disease course.
- Subjects must be ambulatory with a Kurtzke's Expanded Disability Status Scale (EDSS) score of 0-5.5 in both screening and baseline visits.
- Subjects must be in a relapse-free, stable neurological condition and free of corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or by mouth (PO)] or ACTH (adrenocorticotropic hormone) 30 days prior to screening (Month-1) and between screening and baseline (Month 0) visits.
- Subjects must have experienced one of the following:
- At least one documented relapse in the 12 months prior to screening,
- At least two documented relapses in the 24 months prior to screening,
- One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in a magnetic resonance imaging (MRI) performed within 12 months prior to screening.
- Subjects must be between 18 and 55 years of age, inclusive.
- Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or a double-barrier method (condom or diaphragm with spermicide)].
- Subjects must be able to sign and date a written informed consent prior to entering the study.
- Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
Any of the following conditions will exclude the subject from entering the study:
- Subjects with progressive forms of MS.
- Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
- Use of immunosuppressive agents (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit.
- Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening.
- Use of cladribine within 2 years prior to screening.
- Previous treatment with immunomodulators [including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg)] within 2 months prior to screening.
- Previous use of glatiramer acetate (GA) or any other glatiramoid.
- Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
- Previous total body irradiation or total lymphoid irradiation.
- Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
- Pregnancy or breastfeeding.
- Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests and chest X-ray. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment.
- A known history of sensitivity to Gadolinium.
- Glomerular filtration rate (GFR) ≤ 60 mL/minute at the screening visit
- Inability to successfully undergo MRI scanning.
- A known drug hypersensitivity to Mannitol.
- Subjects who underwent endovascular treatment for chronic cerebrospinal venous insufficiency (CCSVI).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Glatiramer Acetate Glatiramer Acetate Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily. Placebo Placebo Placebo solution in prefilled syringe for subcutaneous injection once daily.
- Primary Outcome Measures
Name Time Method The Annualized Relapse Rate During the Placebo Controlled Period Day 1 up to Month 12 The total number of confirmed relapses during the placebo-controlled phase is divided by the sum of the number of days on study in the placebo-controlled phase and then multiplied by the number of days in the year to calculate the annualized relapse rate.
- Secondary Outcome Measures
Name Time Method The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period) Day 1 up to Month 12 Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions.
The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period) Day 1 up to Month 12 Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.
Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume Day 1 up to Month 12 Brain atrophy was defined by the percent brain volume change from baseline to Month 12
Trial Locations
- Locations (169)
Teva Investigational Site 10212
🇺🇸Raleigh, North Carolina, United States
Teva Investigational Site 68004
🇧🇾Grodno, Belarus
Teva Investigational Site 59027
🇧🇬Veliko Tarnovo, Bulgaria
Teva Investigational Site 68002
🇧🇾Vitebsk, Belarus
Teva Investigational Site 69004
🇧🇦Bihac, Bosnia and Herzegovina
Teva Investigational Site 69002
🇧🇦Mostar, Bosnia and Herzegovina
Teva Investigational Site 60004
🇭🇷Zagreb, Croatia
Teva Investigational Site 55003
🇪🇪Tallinn, Estonia
Teva Investigational Site 59018
🇧🇬Pleven, Bulgaria
Teva Investigational Site 59006
🇧🇬Sofia, Bulgaria
Teva Investigational Site 60003
🇭🇷Osijek, Croatia
Teva Investigational Site 60006
🇭🇷Zagreb, Croatia
Teva Investigational Site 60007
🇭🇷Zagreb, Croatia
Teva Investigational Site 81003
🇬🇪Tbilisi, Georgia
Teva Investigational Site 81004
🇬🇪Tbilisi, Georgia
Teva Investigational Site 81005
🇬🇪Tbilisi, Georgia
Teva Investigational Site 63017
🇬🇷Athens, Greece
Teva Investigational Site 63019
🇬🇷Thessaloniki, Greece
Teva Investigational Site 81001
🇬🇪Tbilisi, Georgia
Teva Investigational Site 81002
🇬🇪Tbilisi, Georgia
Teva Investigational Site 70001
🇲🇩Chisinau, Moldova, Republic of
Teva Investigational Site 63018
🇬🇷Thessaloniki, Greece
Teva Investigational Site 56004
🇱🇻Riga, Latvia
Teva Investigational Site 21021
🇲🇽Guadalajara, JALISCO, Mexico
Teva Investigational Site 21022
🇲🇽Mexico City, DISTRITO FEDERAL, Mexico
Teva Investigational Site 21025
🇲🇽Monterrey, Mexico
Teva Investigational Site 21020
🇲🇽Morelia, MICHOACAN, Mexico
Teva Investigational Site 21024
🇲🇽San Luís Potosí, Mexico
Teva Investigational Site 70002
🇲🇩Chisinau, Moldova, Republic of
Teva Investigational Site 70004
🇲🇩Chisinau, Moldova, Republic of
Teva Investigational Site 66001
🇲🇪Podgorica, Montenegro
Teva Investigational Site 53033
🇵🇱Bialystok, Poland
Teva Investigational Site 70003
🇲🇩Chisinau, Moldova, Republic of
Teva Investigational Site 53020
🇵🇱Czestochowa, Poland
Teva Investigational Site 53023
🇵🇱Gdansk, Poland
Teva Investigational Site 53024
🇵🇱Gdansk, Poland
Teva Investigational Site 53031
🇵🇱Grodzisk Mazowiecki, Poland
Teva Investigational Site 53021
🇵🇱Katowice, Poland
Teva Investigational Site 53019
🇵🇱Kielce, Poland
Teva Investigational Site 53028
🇵🇱Konstancin-Jeziorna, Poland
Teva Investigational Site 53037
🇵🇱Koscierzyna, Poland
Teva Investigational Site 53018
🇵🇱Lodz, Poland
Teva Investigational Site 53036
🇵🇱Olsztyn, Poland
Teva Investigational Site 53030
🇵🇱Poznan / Plewiska, Poland
Teva Investigational Site 53034
🇵🇱Poznan, Poland
Teva Investigational Site 53025
🇵🇱Szczecin, Poland
Teva Investigational Site 53026
🇵🇱Szczecin, Poland
Teva Investigational Site 53022
🇵🇱Warsaw, Poland
Teva Investigational Site 52010
🇷🇴Bucuresti, Romania
Teva Investigational Site 52012
🇷🇴Bucuresti, Romania
Teva Investigational Site 52015
🇷🇴Cluj-Napoca, Romania
Teva Investigational Site 52017
🇷🇴Constanta, Romania
Teva Investigational Site 52014
🇷🇴Iasi, Romania
Teva Investigational Site 52021
🇷🇴Oradea, Romania
Teva Investigational Site 52020
🇷🇴Targu-Mures, Romania
Teva Investigational Site 50039
🇷🇺Krasnodar, Russian Federation
Teva Investigational Site 50034
🇷🇺Moscow, Russian Federation
Teva Investigational Site 50036
🇷🇺Moscow, Russian Federation
Teva Investigational Site 52011
🇷🇴Piatra-Neamt, Romania
Teva Investigational Site 52013
🇷🇴Sibiu, Romania
Teva Investigational Site 50023
🇷🇺Barnaul, Russian Federation
Teva Investigational Site 50027
🇷🇺Novosibirsk, Russian Federation
Teva Investigational Site 50038
🇷🇺Rostov-on-Don, Russian Federation
Teva Investigational Site 50030
🇷🇺Samara, Russian Federation
Teva Investigational Site 50021
🇷🇺Chelyabinsk, Russian Federation
Teva Investigational Site 50024
🇷🇺Nizhny Novgorod, Russian Federation
Teva Investigational Site 58023
🇺🇦Kyiv, Ukraine
Teva Investigational Site 58018
🇺🇦Lviv, Ukraine
Teva Investigational Site 58031
🇺🇦Uzhgorod, Ukraine
Teva Investigational Site 50025
🇷🇺Kazan, Russian Federation
Teva Investigational Site 50020
🇷🇺Nizhny Novgorod, Russian Federation
Teva Investigational Site 50032
🇷🇺Saint Petersburg, Russian Federation
Teva Investigational Site 50037
🇷🇺Saratov, Russian Federation
Teva Investigational Site 50040
🇷🇺Volgograd, Russian Federation
Teva Investigational Site 50033
🇷🇺Yaroslavl, Russian Federation
Teva Investigational Site 61005
🇷🇸Belgrade, Serbia
Teva Investigational Site 50123
🇷🇺Nizhny Novgorod, Russian Federation
Teva Investigational Site 50031
🇷🇺Tyumen, Russian Federation
Teva Investigational Site 50026
🇷🇺Ufa, Russian Federation
Teva Investigational Site 50022
🇷🇺Moscow, Russian Federation
Teva Investigational Site 50035
🇷🇺Moscow, Russian Federation
Teva Investigational Site 50019
🇷🇺Perm, Russian Federation
Teva Investigational Site 58030
🇺🇦Donetsk, Ukraine
Teva Investigational Site 58032
🇺🇦Simferopol, AR Crimea, Ukraine
Teva Investigational Site 58021
🇺🇦Odessa, Ukraine
Teva Investigational Site 58024
🇺🇦Zaporizhzhya, Ukraine
Teva Investigational Site 58029
🇺🇦Poltava, Ukraine
Teva Investigational Site 10192
🇺🇸Cullman, Alabama, United States
Teva Investigational Site 10197
🇺🇸Sarasota, Florida, United States
Teva Investigational Site 10194
🇺🇸Akron, Ohio, United States
Teva Investigational Site 65006
🇲🇰Strumica, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65005
🇲🇰Shtip, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 61003
🇷🇸Nis, Serbia
Teva Investigational Site 58025
🇺🇦Kyiv, Ukraine
Teva Investigational Site 58022
🇺🇦Chernihiv, Ukraine
Teva Investigational Site 58020
🇺🇦Ivano-Frankivsk, Ukraine
Teva Investigational Site 10184
🇺🇸Miami, Florida, United States
Teva Investigational Site 10181
🇺🇸Chicago, Illinois, United States
Teva Investigational Site 10196
🇺🇸Centennial, Colorado, United States
Teva Investigational Site 10186
🇺🇸Nashville, Tennessee, United States
Teva Investigational Site 10204
🇺🇸Fresno, California, United States
Teva Investigational Site 10201
🇺🇸La Jolla, California, United States
Teva Investigational Site 10180
🇺🇸Sarasota, Florida, United States
Teva Investigational Site 10190
🇺🇸Tampa, Florida, United States
Teva Investigational Site 10202
🇺🇸Northbrook, Illinois, United States
Teva Investigational Site 10203
🇺🇸Hickory, North Carolina, United States
Teva Investigational Site 10198
🇺🇸Charlotte, North Carolina, United States
Teva Investigational Site 10209
🇺🇸Hickory, North Carolina, United States
Teva Investigational Site 10213
🇺🇸Winston-Salem, North Carolina, United States
Teva Investigational Site 10191
🇺🇸Dayton, Ohio, United States
Teva Investigational Site 10215
🇺🇸Winston Salem, North Carolina, United States
Teva Investigational Site 10200
🇺🇸Uniontown, Ohio, United States
Teva Investigational Site 10214
🇺🇸Cordova, Tennessee, United States
Teva Investigational Site 10206
🇺🇸Cordova, Tennessee, United States
Teva Investigational Site 67001
🇦🇱Tirana, Albania
Teva Investigational Site 68007
🇧🇾Gomel, Belarus
Teva Investigational Site 68003
🇧🇾Minsk, Belarus
Teva Investigational Site 68006
🇧🇾Minsk, Belarus
Teva Investigational Site 68005
🇧🇾Minsk, Belarus
Teva Investigational Site 68001
🇧🇾Vitebsk, Belarus
Teva Investigational Site 69001
🇧🇦Sarajevo, Bosnia and Herzegovina
Teva Investigational Site 59020
🇧🇬Blagoevgrad, Bulgaria
Teva Investigational Site 69003
🇧🇦Tuzla, Bosnia and Herzegovina
Teva Investigational Site 59019
🇧🇬Pleven, Bulgaria
Teva Investigational Site 59025
🇧🇬Pleven, Bulgaria
Teva Investigational Site 59024
🇧🇬Ruse, Bulgaria
Teva Investigational Site 59023
🇧🇬Shumen, Bulgaria
Teva Investigational Site 59007
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59008
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59009
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59010
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59011
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59012
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59014
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59015
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59017
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59021
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59016
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59026
🇧🇬Sofia, Bulgaria
Teva Investigational Site 59022
🇧🇬Stara Zagora, Bulgaria
Teva Investigational Site 59013
🇧🇬Varna, Bulgaria
Teva Investigational Site 59028
🇧🇬Veliko Tarnovo, Bulgaria
Teva Investigational Site 60002
🇭🇷Zagreb, Croatia
Teva Investigational Site 60005
🇭🇷Varazdin, Croatia
Teva Investigational Site 60001
🇭🇷Zagreb, Croatia
Teva Investigational Site 55004
🇪🇪Paernu, Estonia
Teva Investigational Site 63020
🇬🇷Melissia, Greece
Teva Investigational Site 63021
🇬🇷Athens, Greece
Teva Investigational Site 65002
🇲🇰Skopje, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65001
🇲🇰Skopje, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 21023
🇲🇽Estado de Mexico, Mexico
Teva Investigational Site 65004
🇲🇰Tetovo, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 53032
🇵🇱Grodzisk Mazowiecki, Poland
Teva Investigational Site 53027
🇵🇱Lublin, Poland
Teva Investigational Site 53029
🇵🇱Warszawa, Poland
Teva Investigational Site 52016
🇷🇴Cluj-Napoca, Romania
Teva Investigational Site 52019
🇷🇴Timisoara, Romania
Teva Investigational Site 52018
🇷🇴Constanta, Romania
Teva Investigational Site 50028
🇷🇺Smolensk, Russian Federation
Teva Investigational Site 50029
🇷🇺St. Petersburg, Russian Federation
Teva Investigational Site 61001
🇷🇸Kragujevac, Serbia
Teva Investigational Site 61002
🇷🇸Belgrade, Serbia
Teva Investigational Site 58028
🇺🇦Kharkiv, Ukraine
Teva Investigational Site 58019
🇺🇦Zaporizhzhya, Ukraine
Teva Investigational Site 58027
🇺🇦Vinnytsya, Ukraine
Teva Investigational Site 10207
🇺🇸Tampa, Florida, United States
Teva Investigational Site 10199
🇺🇸Vero Beach, Florida, United States
Teva Investigational Site 10188
🇺🇸Patchogue, New York, United States
Teva Investigational Site 65003
🇲🇰Skopje, Macedonia, The Former Yugoslav Republic of