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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Synthon BV
ClinicalTrials.gov Identifier:
NCT01489254
First received: December 8, 2011
Last updated: March 31, 2014
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis
Drug: Glatiramer Acetate (GTR)
Drug: Glatiramer Acetate (Copaxone®)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Synthon BV:

Primary Outcome Measures:
  • The number of Gadolinium enhancing lesions during months 7-9 [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: October 2011
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GTR
Drug
Drug: Glatiramer Acetate (GTR)
Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2)
Active Comparator: Copaxone®
Drug
Drug: Glatiramer Acetate (Copaxone®)
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
Drug: Placebo
Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)

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.

  Eligibility

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

    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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489254

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

No publications provided

Responsible Party: Synthon BV
ClinicalTrials.gov Identifier: NCT01489254     History of Changes
Other Study ID Numbers: GTR001, 2011-000888-27
Study First Received: December 8, 2011
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Belarus: Ministry of Health of the Republic of Belarus
Belarus: Local Ethics Committees
Bosnia and Herzegovina: Medicines and Medical Devices Agency
Bosnia and Herzegovina: Ethics Committees at Medical sites
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ethics Committee for Multicenter Clinical Trials
Croatia: Ministry of Health
Croatia: Central Ethics Committee
Czech Republic: State Institute for Drug Control (SUKL)
Czech Republic: Multicenter Ethics Committee
Estonia: State Agency of Medicines
Estonia: Central Ethics Committee
Georgia: Ministry of Labour, Health and Social Affairs
Georgia: Ethics Committees at Medical sites
Germany: Federal Agency for Medicinal Products and Medical Devices (BfArM)
Germany: Regional Independent Ethics Committee
Italy: Regulatory Authority at Medical Site
Italy: Ethics Committee at Medical site
Mexico: Federal Commission for Protection against Sanitary Risks
Mexico: Ethics Committees at Medical sites
Moldova: Medicine Agency
Moldova: National Ethics Committee
Poland: Central Register of clinical trials
Poland: Multicenter Ethics Committee
Romania: National Medicine and Medical Devices Agency
Romania: National Ethics Committee
Russia: Ministry of Healthcare and Social Development of the Russian Federation
Serbia: Medicines and Medical Devices Agency
Serbia: Ethics Committees at Medical Sites
South Africa: Medicines Control Council (MCC)
South Africa: Ethics Committees at Medical sites
UK: The Medicines and Healthcare products Regulatory Agency
UK: Regional Independent Ethics Committee
Ukraine: State Expert Centre under the Ministry of Health of Ukraine
Ukraine: Central Ethics Committee

Keywords provided by Synthon BV:
Multiple Sclerosis,
Relapsing-Remitting Multiple Sclerosis,
glatiramer acetate,
MRI,
lesions,
MS relapse rate,
Copaxone

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

ClinicalTrials.gov processed this record on April 17, 2014