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

November 10, 2016 updated by: Synthon BV

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

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

794

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

      • Bitebsk, Belarus
        • Synthon investigational site 401
      • Gomel, Belarus
        • Synthon investigational site 402
      • Grodno, Belarus
        • Synthon investigational site 403
      • Minsk, Belarus
        • Synthon investigational site 404
      • Minsk, Belarus
        • Synthon investigational site 407
      • Minsk, Belarus
        • Synthon investigational site 408
      • Vitebsk, Belarus
        • Synthon investigational site 405
      • Banja Luka, Bosnia and Herzegovina
        • Synthon investigational site 486
      • Sarajevo, Bosnia and Herzegovina
        • Synthon investigational site 487
      • Tuzla, Bosnia and Herzegovina
        • Synthon investigational site 488
      • Pleven, Bulgaria
        • Synthon investigational site 204
      • Pleven, Bulgaria
        • Synthon investigational site 207
      • Plovdiv, Bulgaria
        • Synthon investigational site 206
      • Sofia, Bulgaria
        • Synthon investigational site 202
      • Sofia, Bulgaria
        • Synthon investigational site 203
      • Sofia, Bulgaria
        • Synthon investigational site 205
      • Sofia, Bulgaria
        • Synthon investigational site 208
      • Varna, Bulgaria
        • Synthon investigational site 201
      • Osijek, Croatia
        • Synthon investigational site 477
      • Zagreb, Croatia
        • Synthon investigational site 475
      • Zagreb, Croatia
        • Synthon investigational site 476
      • Zagreb, Croatia
        • Synthon investigational site 478
      • Brno, Czech Republic
        • Synthon investigational site 211
      • Brno, Czech Republic
        • Synthon investigational site 217
      • Olomouc, Czech Republic
        • Synthon investigational site 210
      • Ostrava, Czech Republic
        • Synthon investigational site 212
      • Praha, Czech Republic
        • Synthon investigational site 215
      • Praha, Czech Republic
        • Synthon investigational site 216
      • Teplice, Czech Republic
        • Synthon investigational site 214
      • Kohtla-Jarve, Estonia
        • Synthon investigational site 297
      • Tallinn, Estonia
        • Synthon investigational site 296
      • Tbilisi, Georgia
        • Synthon investigational site 526
      • Tbilisi, Georgia
        • Synthon investigational site 527
      • Tbilisi, Georgia
        • Synthon investigational site 528
      • Tbilisi, Georgia
        • Synthon investigational site 529
      • Tbilisi, Georgia
        • Synthon investigational site 530
      • Jena, Germany
        • Synthon investigational site 227
      • Coppito, Italy
        • Synthon investigational site 234
      • Naples, Italy
        • Synthon investigational site 235
      • Guadalajara, Mexico
        • Synthon investigational site 516
      • Mexico City, Mexico
        • Synthon investigational site 512
      • Mexico City, Mexico
        • Synthon investigational site 514
      • Morelia, Mexico
        • Synthon investigational site 515
      • Chisinau, Moldova, Republic of
        • Synthon investigational site 547
      • Chisinau, Moldova, Republic of
        • Synthon investigational site 548
      • Chisinau, Moldova, Republic of
        • Synthon investigational site 549
      • Chisinau, Moldova, Republic of
        • Synthon investigational site 550
      • Bialystok, Poland
        • Synthon investigational site 244
      • Katowice, Poland
        • Synthon investigational site 240
      • Katowice, Poland
        • Synthon investigational site 241
      • Katowice, Poland
        • Synthon investigational site 242
      • Katowice, Poland
        • Synthon investigational site 245
      • Lodz, Poland
        • Synthon investigational site 247
      • Lublin, Poland
        • Synthon investigational site 251
      • Olsztyn, Poland
        • Synthon investigational site 243
      • Poznan, Poland
        • Synthon investigational site 248
      • Szczecin, Poland
        • Synthon investigational site 250
      • Warszawa, Poland
        • Synthon investigational site 246
      • Wroclaw, Poland
        • Synthon investigational site 249
      • Bucharest, Romania
        • Synthon investigational site 260
      • Bucharest, Romania
        • Synthon investigational site 262
      • Bucharest, Romania
        • Synthon investigational site 263
      • Bucharest, Romania
        • Synthon investigational site 264
      • Bucharest, Romania
        • Synthon investigational site 265
      • Cluj-Napoca, Romania
        • Synthon investigational site 266
      • Timisoara, Romania
        • Synthon investigational site 267
      • Arkhangelsk, Russian Federation
        • Synthon investigational site 438
      • Barnaul, Russian Federation
        • Synthon investigational site 435
      • Belgorod, Russian Federation
        • Synthon investigational site 437
      • Ekaterinburg, Russian Federation
        • Synthon investigational site 431
      • Kaluga, Russian Federation
        • Synthon investigational site 445
      • Kazan, Russian Federation
        • Synthon investigational site 427
      • Kemerovo, Russian Federation
        • Synthon investigational site 432
      • Kirov, Russian Federation
        • Synthon investigational site 447
      • Lipetsk, Russian Federation
        • Synthon investigational site 446
      • Moscow, Russian Federation
        • Synthon investigational site 571
      • Nizhniy Novgorod, Russian Federation
        • Synthon investigational site 428
      • Nizhniy Novgorod, Russian Federation
        • Synthon investigational site 429
      • Novosibirsk, Russian Federation
        • Synthon investigational site 434
      • Novosibirsk, Russian Federation
        • Synthon investigational site 442
      • Penza, Russian Federation
        • Synthon investigational site 444
      • Pyatigorsk, Russian Federation
        • Synthon investigational site 433
      • Samara, Russian Federation
        • Synthon investigational site 424
      • Smolensk, Russian Federation
        • Synthon investigational site 420
      • St.Petersburg, Russian Federation
        • Synthon investigational site 421
      • St.Petersburg, Russian Federation
        • Synthon investigational site 426
      • St.Petersburg, Russian Federation
        • Synthon investigational site 430
      • St.Petersburg, Russian Federation
        • Synthon investigational site 440
      • Tomsk, Russian Federation
        • Synthon investigational site 422
      • Tver, Russian Federation
        • Synthon investigational site 441
      • Tyumen, Russian Federation
        • Synthon investigational site 425
      • Ufa, Russian Federation
        • Synthon investigational site 423
      • Belgrade, Serbia
        • Synthon investigational site 450
      • Belgrade, Serbia
        • Synthon investigational site 451
      • Kragujevac, Serbia
        • Synthon investigational site 453
      • Novi Sad, Serbia
        • Synthon investigational site 452
      • Cape Town, South Africa
        • Synthon investigational site 501
      • Durban, South Africa
        • Synthon investigational site 505
      • Pretoria, South Africa
        • Synthon investigational site 502
      • Cherkassy, Ukraine
        • Synthon investigational site 474
      • Chernihiv, Ukraine
        • Synthon investigational site 459
      • Chernivtsi, Ukraine
        • Synthon investigational site 463
      • Dnepropetrovsk, Ukraine
        • Synthon investigational site 458
      • Dnepropetrovsk, Ukraine
        • Synthon investigational site 472
      • Donetsk, Ukraine
        • Synthon investigational site 464
      • Donetsk, Ukraine
        • Synthon investigational site 468
      • Ivano-Frankivsk, Ukraine
        • Synthon investigational site 495
      • Kharkiv, Ukraine
        • Synthon investigational site 461
      • Kharkiv, Ukraine
        • Synthon investigational site 469
      • Kyiv, Ukraine
        • Synthon investigational site 455
      • Kyiv, Ukraine
        • Synthon investigational site 456
      • Kyiv, Ukraine
        • Synthon investigational site 496
      • Lutsk, Ukraine
        • Synthon investigational site 473
      • Lviv, Ukraine
        • Synthon investigational site 462
      • Lviv, Ukraine
        • Synthon investigational site 466
      • Lviv, Ukraine
        • Synthon investigational site 497
      • Mariupol, Ukraine
        • Synthon investigational site 498
      • Odessa, Ukraine
        • Synthon investigational site 457
      • Poltava, Ukraine
        • Synthon investigational site 470
      • Uzhhorod, Ukraine
        • Synthon investigational site 471
      • Vinnytsia, Ukraine
        • Synthon investigational site 465
      • Zhytomyr, Ukraine
        • Synthon investigational site 460
      • Sheffield, United Kingdom
        • Synthon investigational site 284
      • Stoke on Trent, United Kingdom
        • Synthon investigational site 281
      • Torquay, United Kingdom
        • Synthon investigational site 283
      • Truro, United Kingdom
        • Synthon investigational site 280
    • California
      • Irvine, California, United States
        • Synthon investigational site 112
    • Florida
      • Port Charlotte, Florida, United States
        • Synthon investigational site 120
      • Sunrise, Florida, United States
        • Synthon investigational site 130
    • Illinois
      • Elk Grove Village, Illinois, United States
        • Synthon investigational site 107
    • North Carolina
      • Raleigh, North Carolina, United States
        • Synthon investigational site 141
    • Ohio
      • Cleveland, Ohio, United States
        • Synthon investigational site 106
      • Dayton, Ohio, United States
        • Synthon investigational site 135

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:

  • 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.

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: GTR
Drug
Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2)
ACTIVE_COMPARATOR: Copaxone®
Drug
Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)
PLACEBO_COMPARATOR: Placebo
Drug
Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of T1-Gadolinium Enhancing Lesions During Months 7-9
Time Frame: 9 months
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.
9 months

Collaborators and Investigators

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

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

October 1, 2011

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

December 8, 2011

First Submitted That Met QC Criteria

December 8, 2011

First Posted (ESTIMATE)

December 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 29, 2016

Last Update Submitted That Met QC Criteria

November 10, 2016

Last Verified

November 1, 2016

More Information

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.

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