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Efficacy and Safety of GTR in Comparison to Copaxone® (GATE)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glatiramer Acetate (GTR)
Glatiramer Acetate (Copaxone®)
Placebo
Sponsored by
Synthon BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis,, Relapsing-Remitting Multiple Sclerosis,, glatiramer acetate,, MRI,, lesions,, MS relapse rate,, Copaxone

Eligibility Criteria

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

Inclusion Criteria:

  • Willing and able to sign written Informed Consent;
  • Female and male subjects aged 18-55 years inclusive at the time of Informed Consent signing;
  • Diagnosis of RRMS according to the revised McDonald criteria;
  • Expanded Disability Status Scale (EDSS) score of 0.0 up to and including 5.5;
  • Neurologically stable with no evidence of relapse within 30 days prior to randomization;
  • Experienced at least 1 relapse in the year before first screening assessment;
  • At least 1 T1-weighted Gadolinium enhancing (T1-GdE) lesion on routine brain MRI taken within 3 months of starting screening or on screening brain MRI (as confirmed by central imaging laboratory;
  • Having a routine brain MRI showing maximally 15 T1-GdE lesions if scan is taken without subject receiving immuno-modulatory treatment, or a routine brain MRI showing maximally 5 T1-GdE lesions when taken while on immuno-modulatory treatment, or a screening MRI showing maximally 15 T1-GdE lesions;
  • Must decline initiation or continuation of treatment with other available disease-modifying drugs for MS, for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator;
  • Female subjects of childbearing potential must agree to practice appropriate contraceptive methods as assessed by the investigator.

Exclusion Criteria:

  • Any life-threatening, medically unstable or otherwise clinically significant condition or findings other than MS, in particular neoplastic disease, seizure disorders, or psychiatric disease;
  • Any clinically significant deviation from reference ranges in laboratory tests;
  • Positive laboratory test results for human immunodeficiency virus (HIV), HBsAg or HCV at screening;
  • Any significant deviation from reference ranges for hepatic function;
  • Positive urine drug screen or history of substance abuse within the year before screening (any use of illicit or prescription drugs or alcohol constituting an abuse pattern in the opinion of the investigator);

  • Having been treated with or having received

    1. at any time:

      • glatiramer acetate, cladribine, rituximab, cyclophosphamide, alemtuzumab, or other immunosuppressive treatments with effects potentially lasting for more than 6 months
      • total lymphoid irradiation or bone marrow transplantation

    2. within one year before screening:

      • mitoxantrone, but subject cannot be enrolled when mitoxantrone was taken at a cumulative lifetime dosing above 100 mg/m2

    3. within 6 months before screening:

      • fingolimod, immunoglobulins and/or monoclonal antibodies (including natalizumab), leflunomide, or putative MS treatments
      • chronic oral or injected corticosteroids or injected ACTH (more than 30 consecutive days)

    4. within 3 months before screening:

      • azathioprine, methotrexate
      • plasma exchange
      • any other experimental intervention, in particular experimental drugs

    5. within 1 month before screening:

      • Interferon-β 1a or 1b
      • short-term oral or injectable corticosteroids for treatment of a relapse
      • short-term ACTH
  • Having, in the opinion of the investigator, consecutively failed on efficacy grounds two full and adequate courses of accepted treatment modalities (normally at least one year of treatment for each);
  • Pregnancy or breastfeeding;
  • Known hypersensitivity to gadolinium-containing products, glatiramer acetate or mannitol;
  • Having an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2;
  • Inability to undergo (repeat) MRI investigations as judged by the investigator, e.g. due to claustrophobia, metal implants or fragments, tattoos or permanent make-up;
  • Any reason why, in the investigator's opinion, the subject should not participate.

Sites / Locations

  • Synthon investigational site 112
  • Synthon investigational site 120
  • Synthon investigational site 130
  • Synthon investigational site 107
  • Synthon investigational site 141
  • Synthon investigational site 106
  • Synthon investigational site 135
  • Synthon investigational site 401
  • Synthon investigational site 402
  • Synthon investigational site 403
  • Synthon investigational site 404
  • Synthon investigational site 407
  • Synthon investigational site 408
  • Synthon investigational site 405
  • Synthon investigational site 486
  • Synthon investigational site 487
  • Synthon investigational site 488
  • Synthon investigational site 204
  • Synthon investigational site 207
  • Synthon investigational site 206
  • Synthon investigational site 202
  • Synthon investigational site 203
  • Synthon investigational site 205
  • Synthon investigational site 208
  • Synthon investigational site 201
  • Synthon investigational site 477
  • Synthon investigational site 475
  • Synthon investigational site 476
  • Synthon investigational site 478
  • Synthon investigational site 211
  • Synthon investigational site 217
  • Synthon investigational site 210
  • Synthon investigational site 212
  • Synthon investigational site 215
  • Synthon investigational site 216
  • Synthon investigational site 214
  • Synthon investigational site 297
  • Synthon investigational site 296
  • Synthon investigational site 526
  • Synthon investigational site 527
  • Synthon investigational site 528
  • Synthon investigational site 529
  • Synthon investigational site 530
  • Synthon investigational site 227
  • Synthon investigational site 234
  • Synthon investigational site 235
  • Synthon investigational site 516
  • Synthon investigational site 512
  • Synthon investigational site 514
  • Synthon investigational site 515
  • Synthon investigational site 547
  • Synthon investigational site 548
  • Synthon investigational site 549
  • Synthon investigational site 550
  • Synthon investigational site 244
  • Synthon investigational site 240
  • Synthon investigational site 241
  • Synthon investigational site 242
  • Synthon investigational site 245
  • Synthon investigational site 247
  • Synthon investigational site 251
  • Synthon investigational site 243
  • Synthon investigational site 248
  • Synthon investigational site 250
  • Synthon investigational site 246
  • Synthon investigational site 249
  • Synthon investigational site 260
  • Synthon investigational site 262
  • Synthon investigational site 263
  • Synthon investigational site 264
  • Synthon investigational site 265
  • Synthon investigational site 266
  • Synthon investigational site 267
  • Synthon investigational site 438
  • Synthon investigational site 435
  • Synthon investigational site 437
  • Synthon investigational site 431
  • Synthon investigational site 445
  • Synthon investigational site 427
  • Synthon investigational site 432
  • Synthon investigational site 447
  • Synthon investigational site 446
  • Synthon investigational site 571
  • Synthon investigational site 428
  • Synthon investigational site 429
  • Synthon investigational site 434
  • Synthon investigational site 442
  • Synthon investigational site 444
  • Synthon investigational site 433
  • Synthon investigational site 424
  • Synthon investigational site 420
  • Synthon investigational site 421
  • Synthon investigational site 426
  • Synthon investigational site 430
  • Synthon investigational site 440
  • Synthon investigational site 422
  • Synthon investigational site 441
  • Synthon investigational site 425
  • Synthon investigational site 423
  • Synthon investigational site 450
  • Synthon investigational site 451
  • Synthon investigational site 453
  • Synthon investigational site 452
  • Synthon investigational site 501
  • Synthon investigational site 505
  • Synthon investigational site 502
  • Synthon investigational site 474
  • Synthon investigational site 459
  • Synthon investigational site 463
  • Synthon investigational site 458
  • Synthon investigational site 472
  • Synthon investigational site 464
  • Synthon investigational site 468
  • Synthon investigational site 495
  • Synthon investigational site 461
  • Synthon investigational site 469
  • Synthon investigational site 455
  • Synthon investigational site 456
  • Synthon investigational site 496
  • Synthon investigational site 473
  • Synthon investigational site 462
  • Synthon investigational site 466
  • Synthon investigational site 497
  • Synthon investigational site 498
  • Synthon investigational site 457
  • Synthon investigational site 470
  • Synthon investigational site 471
  • Synthon investigational site 465
  • Synthon investigational site 460
  • Synthon investigational site 284
  • Synthon investigational site 281
  • Synthon investigational site 283
  • Synthon investigational site 280

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

GTR

Copaxone®

Placebo

Arm Description

Drug

Drug

Drug

Outcomes

Primary Outcome Measures

The Number of T1-Gadolinium Enhancing Lesions During Months 7-9
The primary endpoint was the total number of gadolinium enhancing lesions (i.e., the cumulative number of new and persisting gadolinium enhancing lesions) during months 7 through 9.

Secondary Outcome Measures

Full Information

First Posted
December 8, 2011
Last Updated
November 10, 2016
Sponsor
Synthon BV
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1. Study Identification

Unique Protocol Identification Number
NCT01489254
Brief Title
Efficacy and Safety of GTR in Comparison to Copaxone®
Acronym
GATE
Official Title
Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, 9 Month, Equivalence Trial Comparing the Efficacy and Safety and Tolerability of GTR (Synthon BV) to Copaxone® (Teva) in Subjects With Relapsing Remitting Multiple Sclerosis Followed by an Open-label 15 Month GTR Treatment Part Evaluating the Long-term GTR Treatment Effects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synthon BV

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple sclerosis
Detailed Description
GTR is being developed by Synthon as a similar version of Copaxone®. GTR has a similar quantitative and qualitative composition as Copaxone®, with regard to active substance and excipients and is presented in the same dosage form (pre-filled syringe containing a solution for injection). Introduction of GTR is anticipated to have a price lowering effect and will give doctors and patients more choice in the pharmaceutical armamentarium for MS. This trial consists of two parts: Part 1 is a multi-country, multi-centre, randomized, double-blind, active and placebo-controlled, equivalence trial comparing the efficacy and safety and tolerability of GTR versus Copaxone® in subjects with RRMS. Eligible subjects will be randomly assigned to receive daily 20 mg GTR (Synthon BV), 20 mg Copaxone® (TEVA) or placebo for a period of 9 months. In Part 2, the trial continues as an open-label uncontrolled trial to evaluate efficacy and safety of long-term treatment with GTR. Subjects completing the 9-month double-blind period will be treated with open-label 20 mg daily GTR for another 15 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis,, Relapsing-Remitting Multiple Sclerosis,, glatiramer acetate,, MRI,, lesions,, MS relapse rate,, Copaxone

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
GTR
Arm Type
Experimental
Arm Description
Drug
Arm Title
Copaxone®
Arm Type
Active Comparator
Arm Description
Drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug
Intervention Type
Drug
Intervention Name(s)
Glatiramer Acetate (GTR)
Intervention Description
Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2)
Intervention Type
Drug
Intervention Name(s)
Glatiramer Acetate (Copaxone®)
Intervention Description
Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)
Primary Outcome Measure Information:
Title
The Number of T1-Gadolinium Enhancing Lesions During Months 7-9
Description
The primary endpoint was the total number of gadolinium enhancing lesions (i.e., the cumulative number of new and persisting gadolinium enhancing lesions) during months 7 through 9.
Time Frame
9 months

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: Willing and able to sign written Informed Consent; Female and male subjects aged 18-55 years inclusive at the time of Informed Consent signing; Diagnosis of RRMS according to the revised McDonald criteria; Expanded Disability Status Scale (EDSS) score of 0.0 up to and including 5.5; Neurologically stable with no evidence of relapse within 30 days prior to randomization; Experienced at least 1 relapse in the year before first screening assessment; At least 1 T1-weighted Gadolinium enhancing (T1-GdE) lesion on routine brain MRI taken within 3 months of starting screening or on screening brain MRI (as confirmed by central imaging laboratory; Having a routine brain MRI showing maximally 15 T1-GdE lesions if scan is taken without subject receiving immuno-modulatory treatment, or a routine brain MRI showing maximally 5 T1-GdE lesions when taken while on immuno-modulatory treatment, or a screening MRI showing maximally 15 T1-GdE lesions; Must decline initiation or continuation of treatment with other available disease-modifying drugs for MS, for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator; Female subjects of childbearing potential must agree to practice appropriate contraceptive methods as assessed by the investigator. Exclusion Criteria: Any life-threatening, medically unstable or otherwise clinically significant condition or findings other than MS, in particular neoplastic disease, seizure disorders, or psychiatric disease; Any clinically significant deviation from reference ranges in laboratory tests; Positive laboratory test results for human immunodeficiency virus (HIV), HBsAg or HCV at screening; Any significant deviation from reference ranges for hepatic function; Positive urine drug screen or history of substance abuse within the year before screening (any use of illicit or prescription drugs or alcohol constituting an abuse pattern in the opinion of the investigator); Having been treated with or having received at any time: glatiramer acetate, cladribine, rituximab, cyclophosphamide, alemtuzumab, or other immunosuppressive treatments with effects potentially lasting for more than 6 months total lymphoid irradiation or bone marrow transplantation within one year before screening: mitoxantrone, but subject cannot be enrolled when mitoxantrone was taken at a cumulative lifetime dosing above 100 mg/m2 within 6 months before screening: fingolimod, immunoglobulins and/or monoclonal antibodies (including natalizumab), leflunomide, or putative MS treatments chronic oral or injected corticosteroids or injected ACTH (more than 30 consecutive days) within 3 months before screening: azathioprine, methotrexate plasma exchange any other experimental intervention, in particular experimental drugs within 1 month before screening: Interferon-β 1a or 1b short-term oral or injectable corticosteroids for treatment of a relapse short-term ACTH Having, in the opinion of the investigator, consecutively failed on efficacy grounds two full and adequate courses of accepted treatment modalities (normally at least one year of treatment for each); Pregnancy or breastfeeding; Known hypersensitivity to gadolinium-containing products, glatiramer acetate or mannitol; Having an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2; Inability to undergo (repeat) MRI investigations as judged by the investigator, e.g. due to claustrophobia, metal implants or fragments, tattoos or permanent make-up; Any reason why, in the investigator's opinion, the subject should not participate.
Facility Information:
Facility Name
Synthon investigational site 112
City
Irvine
State/Province
California
Country
United States
Facility Name
Synthon investigational site 120
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
Synthon investigational site 130
City
Sunrise
State/Province
Florida
Country
United States
Facility Name
Synthon investigational site 107
City
Elk Grove Village
State/Province
Illinois
Country
United States
Facility Name
Synthon investigational site 141
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Synthon investigational site 106
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Synthon investigational site 135
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Synthon investigational site 401
City
Bitebsk
Country
Belarus
Facility Name
Synthon investigational site 402
City
Gomel
Country
Belarus
Facility Name
Synthon investigational site 403
City
Grodno
Country
Belarus
Facility Name
Synthon investigational site 404
City
Minsk
Country
Belarus
Facility Name
Synthon investigational site 407
City
Minsk
Country
Belarus
Facility Name
Synthon investigational site 408
City
Minsk
Country
Belarus
Facility Name
Synthon investigational site 405
City
Vitebsk
Country
Belarus
Facility Name
Synthon investigational site 486
City
Banja Luka
Country
Bosnia and Herzegovina
Facility Name
Synthon investigational site 487
City
Sarajevo
Country
Bosnia and Herzegovina
Facility Name
Synthon investigational site 488
City
Tuzla
Country
Bosnia and Herzegovina
Facility Name
Synthon investigational site 204
City
Pleven
Country
Bulgaria
Facility Name
Synthon investigational site 207
City
Pleven
Country
Bulgaria
Facility Name
Synthon investigational site 206
City
Plovdiv
Country
Bulgaria
Facility Name
Synthon investigational site 202
City
Sofia
Country
Bulgaria
Facility Name
Synthon investigational site 203
City
Sofia
Country
Bulgaria
Facility Name
Synthon investigational site 205
City
Sofia
Country
Bulgaria
Facility Name
Synthon investigational site 208
City
Sofia
Country
Bulgaria
Facility Name
Synthon investigational site 201
City
Varna
Country
Bulgaria
Facility Name
Synthon investigational site 477
City
Osijek
Country
Croatia
Facility Name
Synthon investigational site 475
City
Zagreb
Country
Croatia
Facility Name
Synthon investigational site 476
City
Zagreb
Country
Croatia
Facility Name
Synthon investigational site 478
City
Zagreb
Country
Croatia
Facility Name
Synthon investigational site 211
City
Brno
Country
Czech Republic
Facility Name
Synthon investigational site 217
City
Brno
Country
Czech Republic
Facility Name
Synthon investigational site 210
City
Olomouc
Country
Czech Republic
Facility Name
Synthon investigational site 212
City
Ostrava
Country
Czech Republic
Facility Name
Synthon investigational site 215
City
Praha
Country
Czech Republic
Facility Name
Synthon investigational site 216
City
Praha
Country
Czech Republic
Facility Name
Synthon investigational site 214
City
Teplice
Country
Czech Republic
Facility Name
Synthon investigational site 297
City
Kohtla-Jarve
Country
Estonia
Facility Name
Synthon investigational site 296
City
Tallinn
Country
Estonia
Facility Name
Synthon investigational site 526
City
Tbilisi
Country
Georgia
Facility Name
Synthon investigational site 527
City
Tbilisi
Country
Georgia
Facility Name
Synthon investigational site 528
City
Tbilisi
Country
Georgia
Facility Name
Synthon investigational site 529
City
Tbilisi
Country
Georgia
Facility Name
Synthon investigational site 530
City
Tbilisi
Country
Georgia
Facility Name
Synthon investigational site 227
City
Jena
Country
Germany
Facility Name
Synthon investigational site 234
City
Coppito
Country
Italy
Facility Name
Synthon investigational site 235
City
Naples
Country
Italy
Facility Name
Synthon investigational site 516
City
Guadalajara
Country
Mexico
Facility Name
Synthon investigational site 512
City
Mexico City
Country
Mexico
Facility Name
Synthon investigational site 514
City
Mexico City
Country
Mexico
Facility Name
Synthon investigational site 515
City
Morelia
Country
Mexico
Facility Name
Synthon investigational site 547
City
Chisinau
Country
Moldova, Republic of
Facility Name
Synthon investigational site 548
City
Chisinau
Country
Moldova, Republic of
Facility Name
Synthon investigational site 549
City
Chisinau
Country
Moldova, Republic of
Facility Name
Synthon investigational site 550
City
Chisinau
Country
Moldova, Republic of
Facility Name
Synthon investigational site 244
City
Bialystok
Country
Poland
Facility Name
Synthon investigational site 240
City
Katowice
Country
Poland
Facility Name
Synthon investigational site 241
City
Katowice
Country
Poland
Facility Name
Synthon investigational site 242
City
Katowice
Country
Poland
Facility Name
Synthon investigational site 245
City
Katowice
Country
Poland
Facility Name
Synthon investigational site 247
City
Lodz
Country
Poland
Facility Name
Synthon investigational site 251
City
Lublin
Country
Poland
Facility Name
Synthon investigational site 243
City
Olsztyn
Country
Poland
Facility Name
Synthon investigational site 248
City
Poznan
Country
Poland
Facility Name
Synthon investigational site 250
City
Szczecin
Country
Poland
Facility Name
Synthon investigational site 246
City
Warszawa
Country
Poland
Facility Name
Synthon investigational site 249
City
Wroclaw
Country
Poland
Facility Name
Synthon investigational site 260
City
Bucharest
Country
Romania
Facility Name
Synthon investigational site 262
City
Bucharest
Country
Romania
Facility Name
Synthon investigational site 263
City
Bucharest
Country
Romania
Facility Name
Synthon investigational site 264
City
Bucharest
Country
Romania
Facility Name
Synthon investigational site 265
City
Bucharest
Country
Romania
Facility Name
Synthon investigational site 266
City
Cluj-Napoca
Country
Romania
Facility Name
Synthon investigational site 267
City
Timisoara
Country
Romania
Facility Name
Synthon investigational site 438
City
Arkhangelsk
Country
Russian Federation
Facility Name
Synthon investigational site 435
City
Barnaul
Country
Russian Federation
Facility Name
Synthon investigational site 437
City
Belgorod
Country
Russian Federation
Facility Name
Synthon investigational site 431
City
Ekaterinburg
Country
Russian Federation
Facility Name
Synthon investigational site 445
City
Kaluga
Country
Russian Federation
Facility Name
Synthon investigational site 427
City
Kazan
Country
Russian Federation
Facility Name
Synthon investigational site 432
City
Kemerovo
Country
Russian Federation
Facility Name
Synthon investigational site 447
City
Kirov
Country
Russian Federation
Facility Name
Synthon investigational site 446
City
Lipetsk
Country
Russian Federation
Facility Name
Synthon investigational site 571
City
Moscow
Country
Russian Federation
Facility Name
Synthon investigational site 428
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Synthon investigational site 429
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Synthon investigational site 434
City
Novosibirsk
Country
Russian Federation
Facility Name
Synthon investigational site 442
City
Novosibirsk
Country
Russian Federation
Facility Name
Synthon investigational site 444
City
Penza
Country
Russian Federation
Facility Name
Synthon investigational site 433
City
Pyatigorsk
Country
Russian Federation
Facility Name
Synthon investigational site 424
City
Samara
Country
Russian Federation
Facility Name
Synthon investigational site 420
City
Smolensk
Country
Russian Federation
Facility Name
Synthon investigational site 421
City
St.Petersburg
Country
Russian Federation
Facility Name
Synthon investigational site 426
City
St.Petersburg
Country
Russian Federation
Facility Name
Synthon investigational site 430
City
St.Petersburg
Country
Russian Federation
Facility Name
Synthon investigational site 440
City
St.Petersburg
Country
Russian Federation
Facility Name
Synthon investigational site 422
City
Tomsk
Country
Russian Federation
Facility Name
Synthon investigational site 441
City
Tver
Country
Russian Federation
Facility Name
Synthon investigational site 425
City
Tyumen
Country
Russian Federation
Facility Name
Synthon investigational site 423
City
Ufa
Country
Russian Federation
Facility Name
Synthon investigational site 450
City
Belgrade
Country
Serbia
Facility Name
Synthon investigational site 451
City
Belgrade
Country
Serbia
Facility Name
Synthon investigational site 453
City
Kragujevac
Country
Serbia
Facility Name
Synthon investigational site 452
City
Novi Sad
Country
Serbia
Facility Name
Synthon investigational site 501
City
Cape Town
Country
South Africa
Facility Name
Synthon investigational site 505
City
Durban
Country
South Africa
Facility Name
Synthon investigational site 502
City
Pretoria
Country
South Africa
Facility Name
Synthon investigational site 474
City
Cherkassy
Country
Ukraine
Facility Name
Synthon investigational site 459
City
Chernihiv
Country
Ukraine
Facility Name
Synthon investigational site 463
City
Chernivtsi
Country
Ukraine
Facility Name
Synthon investigational site 458
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Synthon investigational site 472
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Synthon investigational site 464
City
Donetsk
Country
Ukraine
Facility Name
Synthon investigational site 468
City
Donetsk
Country
Ukraine
Facility Name
Synthon investigational site 495
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Synthon investigational site 461
City
Kharkiv
Country
Ukraine
Facility Name
Synthon investigational site 469
City
Kharkiv
Country
Ukraine
Facility Name
Synthon investigational site 455
City
Kyiv
Country
Ukraine
Facility Name
Synthon investigational site 456
City
Kyiv
Country
Ukraine
Facility Name
Synthon investigational site 496
City
Kyiv
Country
Ukraine
Facility Name
Synthon investigational site 473
City
Lutsk
Country
Ukraine
Facility Name
Synthon investigational site 462
City
Lviv
Country
Ukraine
Facility Name
Synthon investigational site 466
City
Lviv
Country
Ukraine
Facility Name
Synthon investigational site 497
City
Lviv
Country
Ukraine
Facility Name
Synthon investigational site 498
City
Mariupol
Country
Ukraine
Facility Name
Synthon investigational site 457
City
Odessa
Country
Ukraine
Facility Name
Synthon investigational site 470
City
Poltava
Country
Ukraine
Facility Name
Synthon investigational site 471
City
Uzhhorod
Country
Ukraine
Facility Name
Synthon investigational site 465
City
Vinnytsia
Country
Ukraine
Facility Name
Synthon investigational site 460
City
Zhytomyr
Country
Ukraine
Facility Name
Synthon investigational site 284
City
Sheffield
Country
United Kingdom
Facility Name
Synthon investigational site 281
City
Stoke on Trent
Country
United Kingdom
Facility Name
Synthon investigational site 283
City
Torquay
Country
United Kingdom
Facility Name
Synthon investigational site 280
City
Truro
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
26458034
Citation
Cohen J, Belova A, Selmaj K, Wolf C, Sormani MP, Oberye J, van den Tweel E, Mulder R, Koper N, Voortman G, Barkhof F; Glatiramer Acetate Clinical Trial to Assess Equivalence With Copaxone (GATE) Study Group. Equivalence of Generic Glatiramer Acetate in Multiple Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2015 Dec;72(12):1433-41. doi: 10.1001/jamaneurol.2015.2154.
Results Reference
result

Learn more about this trial

Efficacy and Safety of GTR in Comparison to Copaxone®

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