search
Back to results

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)

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glatiramer Acetate
Placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Teva Investigational Site 10192
  • Teva Investigational Site 10204
  • Teva Investigational Site 10201
  • Teva Investigational Site 10196
  • Teva Investigational Site 10184
  • Teva Investigational Site 10180
  • Teva Investigational Site 10197
  • Teva Investigational Site 10190
  • Teva Investigational Site 10207
  • Teva Investigational Site 10199
  • Teva Investigational Site 10181
  • Teva Investigational Site 10202
  • Teva Investigational Site 10188
  • Teva Investigational Site 10198
  • Teva Investigational Site 10203
  • Teva Investigational Site 10209
  • Teva Investigational Site 10212
  • Teva Investigational Site 10215
  • Teva Investigational Site 10213
  • Teva Investigational Site 10194
  • Teva Investigational Site 10191
  • Teva Investigational Site 10200
  • Teva Investigational Site 10206
  • Teva Investigational Site 10214
  • Teva Investigational Site 10186
  • Teva Investigational Site 67001
  • Teva Investigational Site 68007
  • Teva Investigational Site 68004
  • Teva Investigational Site 68003
  • Teva Investigational Site 68005
  • Teva Investigational Site 68006
  • Teva Investigational Site 68001
  • Teva Investigational Site 68002
  • Teva Investigational Site 69004
  • Teva Investigational Site 69002
  • Teva Investigational Site 69001
  • Teva Investigational Site 69003
  • Teva Investigational Site 59020
  • Teva Investigational Site 59018
  • Teva Investigational Site 59019
  • Teva Investigational Site 59025
  • Teva Investigational Site 59024
  • Teva Investigational Site 59023
  • Teva Investigational Site 59006
  • Teva Investigational Site 59007
  • Teva Investigational Site 59008
  • Teva Investigational Site 59009
  • Teva Investigational Site 59010
  • Teva Investigational Site 59011
  • Teva Investigational Site 59012
  • Teva Investigational Site 59014
  • Teva Investigational Site 59015
  • Teva Investigational Site 59016
  • Teva Investigational Site 59017
  • Teva Investigational Site 59021
  • Teva Investigational Site 59026
  • Teva Investigational Site 59022
  • Teva Investigational Site 59013
  • Teva Investigational Site 59027
  • Teva Investigational Site 59028
  • Teva Investigational Site 60003
  • Teva Investigational Site 60005
  • Teva Investigational Site 60001
  • Teva Investigational Site 60002
  • Teva Investigational Site 60004
  • Teva Investigational Site 60006
  • Teva Investigational Site 60007
  • Teva Investigational Site 55004
  • Teva Investigational Site 55003
  • Teva Investigational Site 81001
  • Teva Investigational Site 81002
  • Teva Investigational Site 81003
  • Teva Investigational Site 81004
  • Teva Investigational Site 81005
  • Teva Investigational Site 63017
  • Teva Investigational Site 63021
  • Teva Investigational Site 63020
  • Teva Investigational Site 63018
  • Teva Investigational Site 63019
  • Teva Investigational Site 56004
  • Teva Investigational Site 65005
  • Teva Investigational Site 65001
  • Teva Investigational Site 65002
  • Teva Investigational Site 65003
  • Teva Investigational Site 65006
  • Teva Investigational Site 65004
  • Teva Investigational Site 21023
  • Teva Investigational Site 21021
  • Teva Investigational Site 21022
  • Teva Investigational Site 21025
  • Teva Investigational Site 21020
  • Teva Investigational Site 21024
  • Teva Investigational Site 70001
  • Teva Investigational Site 70002
  • Teva Investigational Site 70003
  • Teva Investigational Site 70004
  • Teva Investigational Site 66001
  • Teva Investigational Site 53033
  • Teva Investigational Site 53020
  • Teva Investigational Site 53023
  • Teva Investigational Site 53024
  • Teva Investigational Site 53031
  • Teva Investigational Site 53032
  • Teva Investigational Site 53021
  • Teva Investigational Site 53019
  • Teva Investigational Site 53028
  • Teva Investigational Site 53037
  • Teva Investigational Site 53018
  • Teva Investigational Site 53027
  • Teva Investigational Site 53036
  • Teva Investigational Site 53030
  • Teva Investigational Site 53034
  • Teva Investigational Site 53025
  • Teva Investigational Site 53026
  • Teva Investigational Site 53022
  • Teva Investigational Site 53029
  • Teva Investigational Site 52010
  • Teva Investigational Site 52012
  • Teva Investigational Site 52015
  • Teva Investigational Site 52016
  • Teva Investigational Site 52017
  • Teva Investigational Site 52018
  • Teva Investigational Site 52014
  • Teva Investigational Site 52021
  • Teva Investigational Site 52011
  • Teva Investigational Site 52013
  • Teva Investigational Site 52020
  • Teva Investigational Site 52019
  • Teva Investigational Site 50023
  • Teva Investigational Site 50021
  • Teva Investigational Site 50025
  • Teva Investigational Site 50039
  • Teva Investigational Site 50022
  • Teva Investigational Site 50034
  • Teva Investigational Site 50035
  • Teva Investigational Site 50036
  • Teva Investigational Site 50020
  • Teva Investigational Site 50024
  • Teva Investigational Site 50123
  • Teva Investigational Site 50027
  • Teva Investigational Site 50019
  • Teva Investigational Site 50038
  • Teva Investigational Site 50032
  • Teva Investigational Site 50030
  • Teva Investigational Site 50037
  • Teva Investigational Site 50028
  • Teva Investigational Site 50029
  • Teva Investigational Site 50031
  • Teva Investigational Site 50026
  • Teva Investigational Site 50040
  • Teva Investigational Site 50033
  • Teva Investigational Site 61002
  • Teva Investigational Site 61005
  • Teva Investigational Site 61001
  • Teva Investigational Site 61003
  • Teva Investigational Site 58022
  • Teva Investigational Site 58030
  • Teva Investigational Site 58020
  • Teva Investigational Site 58028
  • Teva Investigational Site 58023
  • Teva Investigational Site 58025
  • Teva Investigational Site 58018
  • Teva Investigational Site 58021
  • Teva Investigational Site 58029
  • Teva Investigational Site 58032
  • Teva Investigational Site 58031
  • Teva Investigational Site 58027
  • Teva Investigational Site 58019
  • Teva Investigational Site 58024

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glatiramer Acetate

Placebo

Arm Description

Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.

Placebo solution in prefilled syringe for subcutaneous injection once daily.

Outcomes

Primary Outcome Measures

The Annualized Relapse Rate During the Placebo Controlled Period
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)
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)
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
Brain atrophy was defined by the percent brain volume change from baseline to Month 12

Full Information

First Posted
March 13, 2012
Last Updated
February 19, 2014
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01578785
Brief Title
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)
Acronym
GLOW
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glatiramer Acetate
Arm Type
Experimental
Arm Description
Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo solution in prefilled syringe for subcutaneous injection once daily.
Intervention Type
Drug
Intervention Name(s)
Glatiramer Acetate
Other Intervention Name(s)
Copaxone®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo injection; 20 mg mannitol dissolved in 0.5 mL water for subcutaneous injection in a PFS is administered daily.
Primary Outcome Measure Information:
Title
The Annualized Relapse Rate During the Placebo Controlled Period
Description
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.
Time Frame
Day 1 up to Month 12
Secondary Outcome Measure Information:
Title
The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period)
Description
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions.
Time Frame
Day 1 up to Month 12
Title
The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period)
Description
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.
Time Frame
Day 1 up to Month 12
Title
Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume
Description
Brain atrophy was defined by the percent brain volume change from baseline to Month 12
Time Frame
Day 1 up to Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexey Boyko, MD
Organizational Affiliation
Department of Neurology, Russian State Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teva Investigational Site 10192
City
Cullman
State/Province
Alabama
Country
United States
Facility Name
Teva Investigational Site 10204
City
Fresno
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10201
City
La Jolla
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10196
City
Centennial
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 10184
City
Miami
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10180
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10197
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10190
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10207
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10199
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10181
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Teva Investigational Site 10202
City
Northbrook
State/Province
Illinois
Country
United States
Facility Name
Teva Investigational Site 10188
City
Patchogue
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10198
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 10203
City
Hickory
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 10209
City
Hickory
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 10212
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 10215
City
Winston Salem
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 10213
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 10194
City
Akron
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10191
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10200
City
Uniontown
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10206
City
Cordova
State/Province
Tennessee
Country
United States
Facility Name
Teva Investigational Site 10214
City
Cordova
State/Province
Tennessee
Country
United States
Facility Name
Teva Investigational Site 10186
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Teva Investigational Site 67001
City
Tirana
Country
Albania
Facility Name
Teva Investigational Site 68007
City
Gomel
Country
Belarus
Facility Name
Teva Investigational Site 68004
City
Grodno
Country
Belarus
Facility Name
Teva Investigational Site 68003
City
Minsk
Country
Belarus
Facility Name
Teva Investigational Site 68005
City
Minsk
Country
Belarus
Facility Name
Teva Investigational Site 68006
City
Minsk
Country
Belarus
Facility Name
Teva Investigational Site 68001
City
Vitebsk
Country
Belarus
Facility Name
Teva Investigational Site 68002
City
Vitebsk
Country
Belarus
Facility Name
Teva Investigational Site 69004
City
Bihac
Country
Bosnia and Herzegovina
Facility Name
Teva Investigational Site 69002
City
Mostar
Country
Bosnia and Herzegovina
Facility Name
Teva Investigational Site 69001
City
Sarajevo
Country
Bosnia and Herzegovina
Facility Name
Teva Investigational Site 69003
City
Tuzla
Country
Bosnia and Herzegovina
Facility Name
Teva Investigational Site 59020
City
Blagoevgrad
Country
Bulgaria
Facility Name
Teva Investigational Site 59018
City
Pleven
Country
Bulgaria
Facility Name
Teva Investigational Site 59019
City
Pleven
Country
Bulgaria
Facility Name
Teva Investigational Site 59025
City
Pleven
Country
Bulgaria
Facility Name
Teva Investigational Site 59024
City
Ruse
Country
Bulgaria
Facility Name
Teva Investigational Site 59023
City
Shumen
Country
Bulgaria
Facility Name
Teva Investigational Site 59006
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59007
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59008
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59009
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59010
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59011
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59012
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59014
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59015
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59016
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59017
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59021
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59026
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59022
City
Stara Zagora
Country
Bulgaria
Facility Name
Teva Investigational Site 59013
City
Varna
Country
Bulgaria
Facility Name
Teva Investigational Site 59027
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
Teva Investigational Site 59028
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
Teva Investigational Site 60003
City
Osijek
Country
Croatia
Facility Name
Teva Investigational Site 60005
City
Varazdin
Country
Croatia
Facility Name
Teva Investigational Site 60001
City
Zagreb
Country
Croatia
Facility Name
Teva Investigational Site 60002
City
Zagreb
Country
Croatia
Facility Name
Teva Investigational Site 60004
City
Zagreb
Country
Croatia
Facility Name
Teva Investigational Site 60006
City
Zagreb
Country
Croatia
Facility Name
Teva Investigational Site 60007
City
Zagreb
Country
Croatia
Facility Name
Teva Investigational Site 55004
City
Paernu
Country
Estonia
Facility Name
Teva Investigational Site 55003
City
Tallinn
Country
Estonia
Facility Name
Teva Investigational Site 81001
City
Tbilisi
Country
Georgia
Facility Name
Teva Investigational Site 81002
City
Tbilisi
Country
Georgia
Facility Name
Teva Investigational Site 81003
City
Tbilisi
Country
Georgia
Facility Name
Teva Investigational Site 81004
City
Tbilisi
Country
Georgia
Facility Name
Teva Investigational Site 81005
City
Tbilisi
Country
Georgia
Facility Name
Teva Investigational Site 63017
City
Athens
Country
Greece
Facility Name
Teva Investigational Site 63021
City
Athens
Country
Greece
Facility Name
Teva Investigational Site 63020
City
Melissia
Country
Greece
Facility Name
Teva Investigational Site 63018
City
Thessaloniki
Country
Greece
Facility Name
Teva Investigational Site 63019
City
Thessaloniki
Country
Greece
Facility Name
Teva Investigational Site 56004
City
Riga
Country
Latvia
Facility Name
Teva Investigational Site 65005
City
Shtip
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Teva Investigational Site 65001
City
Skopje
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Teva Investigational Site 65002
City
Skopje
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Teva Investigational Site 65003
City
Skopje
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Teva Investigational Site 65006
City
Strumica
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Teva Investigational Site 65004
City
Tetovo
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Teva Investigational Site 21023
City
Estado de Mexico
Country
Mexico
Facility Name
Teva Investigational Site 21021
City
Guadalajara, JALISCO
Country
Mexico
Facility Name
Teva Investigational Site 21022
City
Mexico City, DISTRITO FEDERAL
Country
Mexico
Facility Name
Teva Investigational Site 21025
City
Monterrey
Country
Mexico
Facility Name
Teva Investigational Site 21020
City
Morelia, MICHOACAN
Country
Mexico
Facility Name
Teva Investigational Site 21024
City
San Luís Potosí
Country
Mexico
Facility Name
Teva Investigational Site 70001
City
Chisinau
Country
Moldova, Republic of
Facility Name
Teva Investigational Site 70002
City
Chisinau
Country
Moldova, Republic of
Facility Name
Teva Investigational Site 70003
City
Chisinau
Country
Moldova, Republic of
Facility Name
Teva Investigational Site 70004
City
Chisinau
Country
Moldova, Republic of
Facility Name
Teva Investigational Site 66001
City
Podgorica
Country
Montenegro
Facility Name
Teva Investigational Site 53033
City
Bialystok
Country
Poland
Facility Name
Teva Investigational Site 53020
City
Czestochowa
Country
Poland
Facility Name
Teva Investigational Site 53023
City
Gdansk
Country
Poland
Facility Name
Teva Investigational Site 53024
City
Gdansk
Country
Poland
Facility Name
Teva Investigational Site 53031
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
Teva Investigational Site 53032
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
Teva Investigational Site 53021
City
Katowice
Country
Poland
Facility Name
Teva Investigational Site 53019
City
Kielce
Country
Poland
Facility Name
Teva Investigational Site 53028
City
Konstancin-Jeziorna
Country
Poland
Facility Name
Teva Investigational Site 53037
City
Koscierzyna
Country
Poland
Facility Name
Teva Investigational Site 53018
City
Lodz
Country
Poland
Facility Name
Teva Investigational Site 53027
City
Lublin
Country
Poland
Facility Name
Teva Investigational Site 53036
City
Olsztyn
Country
Poland
Facility Name
Teva Investigational Site 53030
City
Poznan / Plewiska
Country
Poland
Facility Name
Teva Investigational Site 53034
City
Poznan
Country
Poland
Facility Name
Teva Investigational Site 53025
City
Szczecin
Country
Poland
Facility Name
Teva Investigational Site 53026
City
Szczecin
Country
Poland
Facility Name
Teva Investigational Site 53022
City
Warsaw
Country
Poland
Facility Name
Teva Investigational Site 53029
City
Warszawa
Country
Poland
Facility Name
Teva Investigational Site 52010
City
Bucuresti
Country
Romania
Facility Name
Teva Investigational Site 52012
City
Bucuresti
Country
Romania
Facility Name
Teva Investigational Site 52015
City
Cluj-Napoca
Country
Romania
Facility Name
Teva Investigational Site 52016
City
Cluj-Napoca
Country
Romania
Facility Name
Teva Investigational Site 52017
City
Constanta
Country
Romania
Facility Name
Teva Investigational Site 52018
City
Constanta
Country
Romania
Facility Name
Teva Investigational Site 52014
City
Iasi
Country
Romania
Facility Name
Teva Investigational Site 52021
City
Oradea
Country
Romania
Facility Name
Teva Investigational Site 52011
City
Piatra-Neamt
Country
Romania
Facility Name
Teva Investigational Site 52013
City
Sibiu
Country
Romania
Facility Name
Teva Investigational Site 52020
City
Targu-Mures
Country
Romania
Facility Name
Teva Investigational Site 52019
City
Timisoara
Country
Romania
Facility Name
Teva Investigational Site 50023
City
Barnaul
Country
Russian Federation
Facility Name
Teva Investigational Site 50021
City
Chelyabinsk
Country
Russian Federation
Facility Name
Teva Investigational Site 50025
City
Kazan
Country
Russian Federation
Facility Name
Teva Investigational Site 50039
City
Krasnodar
Country
Russian Federation
Facility Name
Teva Investigational Site 50022
City
Moscow
Country
Russian Federation
Facility Name
Teva Investigational Site 50034
City
Moscow
Country
Russian Federation
Facility Name
Teva Investigational Site 50035
City
Moscow
Country
Russian Federation
Facility Name
Teva Investigational Site 50036
City
Moscow
Country
Russian Federation
Facility Name
Teva Investigational Site 50020
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Teva Investigational Site 50024
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Teva Investigational Site 50123
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Teva Investigational Site 50027
City
Novosibirsk
Country
Russian Federation
Facility Name
Teva Investigational Site 50019
City
Perm
Country
Russian Federation
Facility Name
Teva Investigational Site 50038
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Teva Investigational Site 50032
City
Saint Petersburg
Country
Russian Federation
Facility Name
Teva Investigational Site 50030
City
Samara
Country
Russian Federation
Facility Name
Teva Investigational Site 50037
City
Saratov
Country
Russian Federation
Facility Name
Teva Investigational Site 50028
City
Smolensk
Country
Russian Federation
Facility Name
Teva Investigational Site 50029
City
St. Petersburg
Country
Russian Federation
Facility Name
Teva Investigational Site 50031
City
Tyumen
Country
Russian Federation
Facility Name
Teva Investigational Site 50026
City
Ufa
Country
Russian Federation
Facility Name
Teva Investigational Site 50040
City
Volgograd
Country
Russian Federation
Facility Name
Teva Investigational Site 50033
City
Yaroslavl
Country
Russian Federation
Facility Name
Teva Investigational Site 61002
City
Belgrade
Country
Serbia
Facility Name
Teva Investigational Site 61005
City
Belgrade
Country
Serbia
Facility Name
Teva Investigational Site 61001
City
Kragujevac
Country
Serbia
Facility Name
Teva Investigational Site 61003
City
Nis
Country
Serbia
Facility Name
Teva Investigational Site 58022
City
Chernihiv
Country
Ukraine
Facility Name
Teva Investigational Site 58030
City
Donetsk
Country
Ukraine
Facility Name
Teva Investigational Site 58020
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Teva Investigational Site 58028
City
Kharkiv
Country
Ukraine
Facility Name
Teva Investigational Site 58023
City
Kyiv
Country
Ukraine
Facility Name
Teva Investigational Site 58025
City
Kyiv
Country
Ukraine
Facility Name
Teva Investigational Site 58018
City
Lviv
Country
Ukraine
Facility Name
Teva Investigational Site 58021
City
Odessa
Country
Ukraine
Facility Name
Teva Investigational Site 58029
City
Poltava
Country
Ukraine
Facility Name
Teva Investigational Site 58032
City
Simferopol, AR Crimea
Country
Ukraine
Facility Name
Teva Investigational Site 58031
City
Uzhgorod
Country
Ukraine
Facility Name
Teva Investigational Site 58027
City
Vinnytsya
Country
Ukraine
Facility Name
Teva Investigational Site 58019
City
Zaporizhzhya
Country
Ukraine
Facility Name
Teva Investigational Site 58024
City
Zaporizhzhya
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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)

We'll reach out to this number within 24 hrs