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) (GLOW)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01578785
First received: March 13, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Drug: Glatiramer Acetate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Randomized, Parallel Group, Double Blind, Placebo Controlled Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate 20mg/0.5ml New Formulation Administered Daily by Subcutaneous Injection

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • The Annualized Relapse Rate During the Placebo Controlled Period [ Time Frame: Day 1 up to Month 12 ] [ Designated as safety issue: No ]
    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:
  • The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period) [ Time Frame: Day 1 up to Month 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Day 1 up to Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 up to Month 12 ] [ Designated as safety issue: No ]
    Brain atrophy was defined by the percent brain volume change from baseline to Month 12


Enrollment: 178
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glatiramer Acetate
Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
Drug: Glatiramer Acetate
Glatiramer acetate 20mg in 0.5ml for subcutaneous injection in a pre-filled syringe (PFS) is administered daily. Each PFS also contains 20mg mannitol dissolved in water for injection.
Other Name: Copaxone®
Placebo Comparator: Placebo
Placebo solution in prefilled syringe for subcutaneous injection once daily.
Drug: Placebo
Matching placebo injection; 20 mg mannitol dissolved in 0.5 mL water for subcutaneous injection in a PFS is administered daily.

Detailed Description:

Approximately 1400 participants were planned for this study, however only 178 were enrolled prior to early termination.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578785

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Locations
United States, Alabama
Teva Investigational Site 10192
Cullman, Alabama, United States
United States, California
Teva Investigational Site 10204
Fresno, California, United States
Teva Investigational Site 10201
La Jolla, California, United States
United States, Colorado
Teva Investigational Site 10196
Centennial, Colorado, United States
United States, Florida
Teva Investigational Site 10184
Miami, Florida, United States
Teva Investigational Site 10180
Sarasota, Florida, United States
Teva Investigational Site 10197
Sarasota, Florida, United States
Teva Investigational Site 10207
Tampa, Florida, United States
Teva Investigational Site 10190
Tampa, Florida, United States
Teva Investigational Site 10199
Vero Beach, Florida, United States
United States, Illinois
Teva Investigational Site 10181
Chicago, Illinois, United States
Teva Investigational Site 10202
Northbrook, Illinois, United States
United States, New York
Teva Investigational Site 10188
Patchogue, New York, United States
United States, North Carolina
Teva Investigational Site 10198
Charlotte, North Carolina, United States
Teva Investigational Site 10203
Hickory, North Carolina, United States
Teva Investigational Site 10209
Hickory, North Carolina, United States
Teva Investigational Site 10212
Raleigh, North Carolina, United States
Teva Investigational Site 10215
Winston Salem, North Carolina, United States
Teva Investigational Site 10213
Winston-Salem, North Carolina, United States
United States, Ohio
Teva Investigational Site 10194
Akron, Ohio, United States
Teva Investigational Site 10191
Dayton, Ohio, United States
Teva Investigational Site 10200
Uniontown, Ohio, United States
United States, Tennessee
Teva Investigational Site 10214
Cordova, Tennessee, United States
Teva Investigational Site 10206
Cordova, Tennessee, United States
Teva Investigational Site 10186
Nashville, Tennessee, United States
Albania
Teva Investigational Site 67001
Tirana, Albania
Belarus
Teva Investigational Site 68007
Gomel, Belarus
Teva Investigational Site 68004
Grodno, Belarus
Teva Investigational Site 68003
Minsk, Belarus
Teva Investigational Site 68005
Minsk, Belarus
Teva Investigational Site 68006
Minsk, Belarus
Teva Investigational Site 68001
Vitebsk, Belarus
Teva Investigational Site 68002
Vitebsk, Belarus
Bosnia and Herzegovina
Teva Investigational Site 69004
Bihac, Bosnia and Herzegovina
Teva Investigational Site 69002
Mostar, Bosnia and Herzegovina
Teva Investigational Site 69001
Sarajevo, Bosnia and Herzegovina
Teva Investigational Site 69003
Tuzla, Bosnia and Herzegovina
Bulgaria
Teva Investigational Site 59020
Blagoevgrad, Bulgaria
Teva Investigational Site 59025
Pleven, Bulgaria
Teva Investigational Site 59018
Pleven, Bulgaria
Teva Investigational Site 59019
Pleven, Bulgaria
Teva Investigational Site 59024
Ruse, Bulgaria
Teva Investigational Site 59023
Shumen, Bulgaria
Teva Investigational Site 59012
Sofia, Bulgaria
Teva Investigational Site 59008
Sofia, Bulgaria
Teva Investigational Site 59014
Sofia, Bulgaria
Teva Investigational Site 59015
Sofia, Bulgaria
Teva Investigational Site 59016
Sofia, Bulgaria
Teva Investigational Site 59021
Sofia, Bulgaria
Teva Investigational Site 59006
Sofia, Bulgaria
Teva Investigational Site 59011
Sofia, Bulgaria
Teva Investigational Site 59007
Sofia, Bulgaria
Teva Investigational Site 59017
Sofia, Bulgaria
Teva Investigational Site 59010
Sofia, Bulgaria
Teva Investigational Site 59009
Sofia, Bulgaria
Teva Investigational Site 59026
Sofia, Bulgaria
Teva Investigational Site 59022
Stara Zagora, Bulgaria
Teva Investigational Site 59013
Varna, Bulgaria
Teva Investigational Site 59027
Veliko Tarnovo, Bulgaria
Teva Investigational Site 59028
Veliko Tarnovo, Bulgaria
Croatia
Teva Investigational Site 60003
Osijek, Croatia
Teva Investigational Site 60005
Varazdin, Croatia
Teva Investigational Site 60004
Zagreb, Croatia
Teva Investigational Site 60002
Zagreb, Croatia
Teva Investigational Site 60006
Zagreb, Croatia
Teva Investigational Site 60001
Zagreb, Croatia
Teva Investigational Site 60007
Zagreb, Croatia
Estonia
Teva Investigational Site 55004
Paernu, Estonia
Teva Investigational Site 55003
Tallinn, Estonia
Georgia
Teva Investigational Site 81001
Tbilisi, Georgia
Teva Investigational Site 81002
Tbilisi, Georgia
Teva Investigational Site 81005
Tbilisi, Georgia
Teva Investigational Site 81003
Tbilisi, Georgia
Teva Investigational Site 81004
Tbilisi, Georgia
Greece
Teva Investigational Site 63017
Athens, Greece
Teva Investigational Site 63021
Athens, Greece
Teva Investigational Site 63020
Melissia, Greece
Teva Investigational Site 63018
Thessaloniki, Greece
Teva Investigational Site 63019
Thessaloniki, Greece
Latvia
Teva Investigational Site 56004
Riga, Latvia
Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65005
Shtip, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65002
Skopje, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65003
Skopje, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65001
Skopje, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65006
Strumica, Macedonia, The Former Yugoslav Republic of
Teva Investigational Site 65004
Tetovo, Macedonia, The Former Yugoslav Republic of
Mexico
Teva Investigational Site 21023
Estado de Mexico, Mexico
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
Moldova, Republic of
Teva Investigational Site 70001
Chisinau, Moldova, Republic of
Teva Investigational Site 70002
Chisinau, Moldova, Republic of
Teva Investigational Site 70003
Chisinau, Moldova, Republic of
Teva Investigational Site 70004
Chisinau, Moldova, Republic of
Montenegro
Teva Investigational Site 66001
Podgorica, Montenegro
Poland
Teva Investigational Site 53033
Bialystok, Poland
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 53032
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 53027
Lublin, Poland
Teva Investigational Site 53036
Olsztyn, Poland
Teva Investigational Site 53034
Poznan, Poland
Teva Investigational Site 53030
Poznan / Plewiska, Poland
Teva Investigational Site 53026
Szczecin, Poland
Teva Investigational Site 53025
Szczecin, Poland
Teva Investigational Site 53022
Warsaw, Poland
Teva Investigational Site 53029
Warszawa, Poland
Romania
Teva Investigational Site 52010
Bucuresti, Romania
Teva Investigational Site 52012
Bucuresti, Romania
Teva Investigational Site 52016
Cluj-Napoca, Romania
Teva Investigational Site 52015
Cluj-Napoca, Romania
Teva Investigational Site 52018
Constanta, Romania
Teva Investigational Site 52017
Constanta, Romania
Teva Investigational Site 52014
Iasi, Romania
Teva Investigational Site 52021
Oradea, Romania
Teva Investigational Site 52011
Piatra-Neamt, Romania
Teva Investigational Site 52013
Sibiu, Romania
Teva Investigational Site 52020
Targu-Mures, Romania
Teva Investigational Site 52019
Timisoara, Romania
Russian Federation
Teva Investigational Site 50023
Barnaul, Russian Federation
Teva Investigational Site 50021
Chelyabinsk, Russian Federation
Teva Investigational Site 50025
Kazan, Russian Federation
Teva Investigational Site 50039
Krasnodar, Russian Federation
Teva Investigational Site 50035
Moscow, Russian Federation
Teva Investigational Site 50036
Moscow, Russian Federation
Teva Investigational Site 50034
Moscow, Russian Federation
Teva Investigational Site 50022
Moscow, Russian Federation
Teva Investigational Site 50024
Nizhny Novgorod, Russian Federation
Teva Investigational Site 50020
Nizhny Novgorod, Russian Federation
Teva Investigational Site 50123
Nizhny Novgorod, Russian Federation
Teva Investigational Site 50027
Novosibirsk, Russian Federation
Teva Investigational Site 50019
Perm, Russian Federation
Teva Investigational Site 50038
Rostov-on-Don, Russian Federation
Teva Investigational Site 50032
Saint Petersburg, Russian Federation
Teva Investigational Site 50030
Samara, Russian Federation
Teva Investigational Site 50037
Saratov, Russian Federation
Teva Investigational Site 50028
Smolensk, Russian Federation
Teva Investigational Site 50029
St. Petersburg, Russian Federation
Teva Investigational Site 50031
Tyumen, Russian Federation
Teva Investigational Site 50026
Ufa, Russian Federation
Teva Investigational Site 50040
Volgograd, Russian Federation
Teva Investigational Site 50033
Yaroslavl, Russian Federation
Serbia
Teva Investigational Site 61005
Belgrade, Serbia
Teva Investigational Site 61002
Belgrade, Serbia
Teva Investigational Site 61001
Kragujevac, Serbia
Teva Investigational Site 61003
Nis, Serbia
Ukraine
Teva Investigational Site 58022
Chernihiv, Ukraine
Teva Investigational Site 58030
Donetsk, Ukraine
Teva Investigational Site 58020
Ivano-Frankivsk, Ukraine
Teva Investigational Site 58028
Kharkiv, Ukraine
Teva Investigational Site 58023
Kyiv, Ukraine
Teva Investigational Site 58025
Kyiv, Ukraine
Teva Investigational Site 58018
Lviv, Ukraine
Teva Investigational Site 58021
Odessa, Ukraine
Teva Investigational Site 58029
Poltava, Ukraine
Teva Investigational Site 58032
Simferopol, AR Crimea, Ukraine
Teva Investigational Site 58031
Uzhgorod, Ukraine
Teva Investigational Site 58027
Vinnytsya, Ukraine
Teva Investigational Site 58024
Zaporizhzhya, Ukraine
Teva Investigational Site 58019
Zaporizhzhya, Ukraine
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Principal Investigator: Alexey Boyko, MD Department of Neurology, Russian State Medical University
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01578785     History of Changes
Other Study ID Numbers: GA-MS-302, 2011-005550-57
Study First Received: March 13, 2012
Results First Received: February 19, 2014
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on August 28, 2014