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)

February 19, 2014 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Albania
      • Tirana, Albania
        • Teva Investigational Site 67001
  • Belarus
      • Gomel, Belarus
        • Teva Investigational Site 68007
      • Grodno, Belarus
        • Teva Investigational Site 68004
      • Minsk, Belarus
        • Teva Investigational Site 68003
      • Minsk, Belarus
        • Teva Investigational Site 68005
      • Minsk, Belarus
        • Teva Investigational Site 68006
      • Vitebsk, Belarus
        • Teva Investigational Site 68001
      • Vitebsk, Belarus
        • Teva Investigational Site 68002
  • Bosnia and Herzegovina
      • Bihac, Bosnia and Herzegovina
        • Teva Investigational Site 69004
      • Mostar, Bosnia and Herzegovina
        • Teva Investigational Site 69002
      • Sarajevo, Bosnia and Herzegovina
        • Teva Investigational Site 69001
      • Tuzla, Bosnia and Herzegovina
        • Teva Investigational Site 69003
  • Bulgaria
      • Blagoevgrad, Bulgaria
        • Teva Investigational Site 59020
      • Pleven, Bulgaria
        • Teva Investigational Site 59018
      • Pleven, Bulgaria
        • Teva Investigational Site 59019
      • Pleven, Bulgaria
        • Teva Investigational Site 59025
      • Ruse, Bulgaria
        • Teva Investigational Site 59024
      • Shumen, Bulgaria
        • Teva Investigational Site 59023
      • Sofia, Bulgaria
        • Teva Investigational Site 59006
      • Sofia, 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 59016
      • Sofia, Bulgaria
        • Teva Investigational Site 59017
      • Sofia, Bulgaria
        • Teva Investigational Site 59021
      • Sofia, Bulgaria
        • Teva Investigational Site 59026
      • Stara Zagora, Bulgaria
        • Teva Investigational Site 59022
      • Varna, Bulgaria
        • Teva Investigational Site 59013
      • Veliko Tarnovo, Bulgaria
        • Teva Investigational Site 59027
      • Veliko Tarnovo, Bulgaria
        • Teva Investigational Site 59028
  • Croatia
      • Osijek, Croatia
        • Teva Investigational Site 60003
      • Varazdin, Croatia
        • Teva Investigational Site 60005
      • Zagreb, Croatia
        • Teva Investigational Site 60001
      • Zagreb, Croatia
        • Teva Investigational Site 60002
      • Zagreb, Croatia
        • Teva Investigational Site 60004
      • Zagreb, Croatia
        • Teva Investigational Site 60006
      • Zagreb, Croatia
        • Teva Investigational Site 60007
  • Estonia
      • Paernu, Estonia
        • Teva Investigational Site 55004
      • Tallinn, Estonia
        • Teva Investigational Site 55003
  • Georgia
      • Tbilisi, Georgia
        • Teva Investigational Site 81001
      • Tbilisi, Georgia
        • Teva Investigational Site 81002
      • Tbilisi, Georgia
        • Teva Investigational Site 81003
      • Tbilisi, Georgia
        • Teva Investigational Site 81004
      • Tbilisi, Georgia
        • Teva Investigational Site 81005
  • Greece
      • Athens, Greece
        • Teva Investigational Site 63017
      • Athens, Greece
        • Teva Investigational Site 63021
      • Melissia, Greece
        • Teva Investigational Site 63020
      • Thessaloniki, Greece
        • Teva Investigational Site 63018
      • Thessaloniki, Greece
        • Teva Investigational Site 63019
  • Latvia
      • Riga, Latvia
        • Teva Investigational Site 56004
  • Macedonia, The Former Yugoslav Republic of
      • Shtip, Macedonia, The Former Yugoslav Republic of
        • Teva Investigational Site 65005
      • Skopje, Macedonia, The Former Yugoslav Republic of
        • Teva Investigational Site 65001
      • Skopje, Macedonia, The Former Yugoslav Republic of
        • Teva Investigational Site 65002
      • Skopje, Macedonia, The Former Yugoslav Republic of
        • Teva Investigational Site 65003
      • Strumica, Macedonia, The Former Yugoslav Republic of
        • Teva Investigational Site 65006
      • Tetovo, Macedonia, The Former Yugoslav Republic of
        • Teva Investigational Site 65004
  • Mexico
      • Estado de Mexico, Mexico
        • Teva Investigational Site 21023
      • Guadalajara, JALISCO, Mexico
        • Teva Investigational Site 21021
      • Mexico City, DISTRITO FEDERAL, Mexico
        • Teva Investigational Site 21022
      • Monterrey, Mexico
        • Teva Investigational Site 21025
      • Morelia, MICHOACAN, Mexico
        • Teva Investigational Site 21020
      • San Luís Potosí, Mexico
        • Teva Investigational Site 21024
  • Moldova, Republic of
      • Chisinau, 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
  • Montenegro
      • Podgorica, Montenegro
        • Teva Investigational Site 66001
  • Poland
      • Bialystok, Poland
        • Teva Investigational Site 53033
      • Czestochowa, Poland
        • Teva Investigational Site 53020
      • Gdansk, Poland
        • Teva Investigational Site 53023
      • Gdansk, Poland
        • Teva Investigational Site 53024
      • Grodzisk Mazowiecki, Poland
        • Teva Investigational Site 53031
      • Grodzisk Mazowiecki, Poland
        • Teva Investigational Site 53032
      • Katowice, Poland
        • Teva Investigational Site 53021
      • Kielce, Poland
        • Teva Investigational Site 53019
      • Konstancin-Jeziorna, Poland
        • Teva Investigational Site 53028
      • Koscierzyna, Poland
        • Teva Investigational Site 53037
      • Lodz, Poland
        • Teva Investigational Site 53018
      • Lublin, Poland
        • Teva Investigational Site 53027
      • Olsztyn, Poland
        • Teva Investigational Site 53036
      • Poznan, Poland
        • Teva Investigational Site 53034
      • Poznan / Plewiska, Poland
        • Teva Investigational Site 53030
      • Szczecin, Poland
        • Teva Investigational Site 53025
      • Szczecin, Poland
        • Teva Investigational Site 53026
      • Warsaw, Poland
        • Teva Investigational Site 53022
      • Warszawa, Poland
        • Teva Investigational Site 53029
  • Romania
      • Bucuresti, Romania
        • Teva Investigational Site 52010
      • Bucuresti, Romania
        • Teva Investigational Site 52012
      • Cluj-Napoca, Romania
        • Teva Investigational Site 52015
      • Cluj-Napoca, Romania
        • Teva Investigational Site 52016
      • Constanta, Romania
        • Teva Investigational Site 52017
      • Constanta, Romania
        • Teva Investigational Site 52018
      • Iasi, Romania
        • Teva Investigational Site 52014
      • Oradea, Romania
        • Teva Investigational Site 52021
      • Piatra-Neamt, Romania
        • Teva Investigational Site 52011
      • Sibiu, Romania
        • Teva Investigational Site 52013
      • Targu-Mures, Romania
        • Teva Investigational Site 52020
      • Timisoara, Romania
        • Teva Investigational Site 52019
  • Russian Federation
      • Barnaul, Russian Federation
        • Teva Investigational Site 50023
      • Chelyabinsk, Russian Federation
        • Teva Investigational Site 50021
      • Kazan, Russian Federation
        • Teva Investigational Site 50025
      • Krasnodar, Russian Federation
        • Teva Investigational Site 50039
      • Moscow, Russian Federation
        • Teva Investigational Site 50022
      • Moscow, Russian Federation
        • Teva Investigational Site 50034
      • Moscow, Russian Federation
        • Teva Investigational Site 50035
      • Moscow, Russian Federation
        • Teva Investigational Site 50036
      • Nizhny Novgorod, Russian Federation
        • Teva Investigational Site 50020
      • Nizhny Novgorod, Russian Federation
        • Teva Investigational Site 50024
      • Nizhny Novgorod, Russian Federation
        • Teva Investigational Site 50123
      • Novosibirsk, Russian Federation
        • Teva Investigational Site 50027
      • Perm, Russian Federation
        • Teva Investigational Site 50019
      • Rostov-on-Don, Russian Federation
        • Teva Investigational Site 50038
      • Saint Petersburg, Russian Federation
        • Teva Investigational Site 50032
      • Samara, Russian Federation
        • Teva Investigational Site 50030
      • Saratov, Russian Federation
        • Teva Investigational Site 50037
      • Smolensk, Russian Federation
        • Teva Investigational Site 50028
      • St. Petersburg, Russian Federation
        • Teva Investigational Site 50029
      • Tyumen, Russian Federation
        • Teva Investigational Site 50031
      • Ufa, Russian Federation
        • Teva Investigational Site 50026
      • Volgograd, Russian Federation
        • Teva Investigational Site 50040
      • Yaroslavl, Russian Federation
        • Teva Investigational Site 50033
  • Serbia
      • Belgrade, Serbia
        • Teva Investigational Site 61002
      • Belgrade, Serbia
        • Teva Investigational Site 61005
      • Kragujevac, Serbia
        • Teva Investigational Site 61001
      • Nis, Serbia
        • Teva Investigational Site 61003
  • Ukraine
      • Chernihiv, Ukraine
        • Teva Investigational Site 58022
      • Donetsk, Ukraine
        • Teva Investigational Site 58030
      • Ivano-Frankivsk, Ukraine
        • Teva Investigational Site 58020
      • Kharkiv, Ukraine
        • Teva Investigational Site 58028
      • Kyiv, Ukraine
        • Teva Investigational Site 58023
      • Kyiv, Ukraine
        • Teva Investigational Site 58025
      • Lviv, Ukraine
        • Teva Investigational Site 58018
      • Odessa, Ukraine
        • Teva Investigational Site 58021
      • Poltava, Ukraine
        • Teva Investigational Site 58029
      • Simferopol, AR Crimea, Ukraine
        • Teva Investigational Site 58032
      • Uzhgorod, Ukraine
        • Teva Investigational Site 58031
      • Vinnytsya, Ukraine
        • Teva Investigational Site 58027
      • Zaporizhzhya, Ukraine
        • Teva Investigational Site 58019
      • Zaporizhzhya, Ukraine
        • Teva Investigational Site 58024
  • United States
    • Alabama
      • Cullman, Alabama, United States
        • Teva Investigational Site 10192
    • California
      • Fresno, California, United States
        • Teva Investigational Site 10204
      • La Jolla, California, United States
        • Teva Investigational Site 10201
    • Colorado
      • Centennial, Colorado, United States
        • Teva Investigational Site 10196
    • Florida
      • Miami, Florida, United States
        • Teva Investigational Site 10184
      • Sarasota, Florida, United States
        • Teva Investigational Site 10180
      • Sarasota, Florida, United States
        • Teva Investigational Site 10197
      • Tampa, Florida, United States
        • Teva Investigational Site 10190
      • Tampa, Florida, United States
        • Teva Investigational Site 10207
      • Vero Beach, Florida, United States
        • Teva Investigational Site 10199
    • Illinois
      • Chicago, Illinois, United States
        • Teva Investigational Site 10181
      • Northbrook, Illinois, United States
        • Teva Investigational Site 10202
    • New York
      • Patchogue, New York, United States
        • Teva Investigational Site 10188
    • North Carolina
      • Charlotte, North Carolina, United States
        • Teva Investigational Site 10198
      • Hickory, North Carolina, United States
        • Teva Investigational Site 10203
      • Hickory, North Carolina, United States
        • Teva Investigational Site 10209
      • Raleigh, North Carolina, United States
        • Teva Investigational Site 10212
      • Winston Salem, North Carolina, United States
        • Teva Investigational Site 10215
      • Winston-Salem, North Carolina, United States
        • Teva Investigational Site 10213
    • Ohio
      • Akron, Ohio, United States
        • Teva Investigational Site 10194
      • Dayton, Ohio, United States
        • Teva Investigational Site 10191
      • Uniontown, Ohio, United States
        • Teva Investigational Site 10200
    • Tennessee
      • Cordova, Tennessee, United States
        • Teva Investigational Site 10206
      • Cordova, Tennessee, United States
        • Teva Investigational Site 10214
      • Nashville, Tennessee, United States
        • Teva Investigational Site 10186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Annualized Relapse Rate During the Placebo Controlled Period
Time Frame: 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.
Day 1 up to Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions.
Day 1 up to Month 12
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
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.
Day 1 up to Month 12
Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume
Time Frame: Day 1 up to Month 12
Brain atrophy was defined by the percent brain volume change from baseline to Month 12
Day 1 up to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Principal Investigator: Alexey Boyko, MD, Department of Neurology, Russian State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

April 15, 2012

First Posted (ESTIMATE)

April 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA-MS-302
  • 2011-005550-57 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe