Efficacy and Safety of GTR in Comparison to Copaxone®

NCT01489254 | Completed Phase 3 Results DMC

• 2 other identifiers: GTR0012011-000888-27
• Study Type: interventional
• Target: 794
• Locations: 19 countries
• Sites: 133

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis,; Relapsing-Remitting Multiple Sclerosis,; glatiramer acetate,; MRI,; lesions,; MS relapse rate,; Copaxone

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Study Arms (3)

GTR

EXPERIMENTAL

Drug

Drug: Glatiramer Acetate (GTR)

Copaxone®

ACTIVE COMPARATOR

Drug

Drug: Glatiramer Acetate (Copaxone®)

Placebo

PLACEBO COMPARATOR

Drug

Drug: Placebo

Interventions

Glatiramer Acetate (GTR) DRUG

Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2)

GTR

Glatiramer Acetate (Copaxone®) DRUG

Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)

Copaxone®

Placebo DRUG

Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Synthon BV: lead

Study Sites (133)

Synthon investigational site 112

Irvine, California, United States

Location

Synthon investigational site 120

Port Charlotte, Florida, United States

Location

Synthon investigational site 130

Sunrise, Florida, United States

Location

Synthon investigational site 107

Elk Grove Village, Illinois, United States

Location

Synthon investigational site 141

Raleigh, North Carolina, United States

Location

Synthon investigational site 106

Cleveland, Ohio, United States

Location

Synthon investigational site 135

Dayton, Ohio, United States

Location

Synthon investigational site 401

Bitebsk, Belarus

Location

Synthon investigational site 403

Grodno, Belarus

Location

Synthon investigational site 402

Homyel, Belarus

Location

Synthon investigational site 404

Minsk, Belarus

Location

Synthon investigational site 407

Minsk, Belarus

Location

Synthon investigational site 408

Minsk, Belarus

Location

Synthon investigational site 405

Vitebsk, Belarus

Location

Synthon investigational site 486

Banja Luka, Bosnia and Herzegovina

Location

Synthon investigational site 487

Sarajevo, Bosnia and Herzegovina

Location

Synthon investigational site 488

Tuzla, Bosnia and Herzegovina

Location

Synthon investigational site 204

Pleven, Bulgaria

Location

Synthon investigational site 207

Pleven, Bulgaria

Location

Synthon investigational site 206

Plovdiv, Bulgaria

Location

Synthon investigational site 202

Sofia, Bulgaria

Location

Synthon investigational site 203

Sofia, Bulgaria

Location

Synthon investigational site 205

Sofia, Bulgaria

Location

Synthon investigational site 208

Sofia, Bulgaria

Location

Synthon investigational site 201

Varna, Bulgaria

Location

Synthon investigational site 477

Osijek, Croatia

Location

Synthon investigational site 475

Zagreb, Croatia

Location

Synthon investigational site 476

Zagreb, Croatia

Location

Synthon investigational site 478

Zagreb, Croatia

Location

Synthon investigational site 211

Brno, Czechia

Location

Synthon investigational site 217

Brno, Czechia

Location

Synthon investigational site 210

Olomouc, Czechia

Location

Synthon investigational site 212

Ostrava, Czechia

Location

Synthon investigational site 215

Prague, Czechia

Location

Synthon investigational site 216

Prague, Czechia

Location

Synthon investigational site 214

Teplice, Czechia

Location

Synthon investigational site 297

Kohtla-Järve, Estonia

Location

Synthon investigational site 296

Tallinn, Estonia

Location

Synthon investigational site 526

Tbilisi, Georgia

Location

Synthon investigational site 527

Tbilisi, Georgia

Location

Synthon investigational site 528

Tbilisi, Georgia

Location

Synthon investigational site 529

Tbilisi, Georgia

Location

Synthon investigational site 530

Tbilisi, Georgia

Location

Synthon investigational site 227

Jena, Germany

Location

Synthon investigational site 234

Coppito, Italy

Location

Synthon investigational site 235

Naples, Italy

Location

Synthon investigational site 516

Guadalajara, Mexico

Location

Synthon investigational site 512

Mexico City, Mexico

Location

Synthon investigational site 514

Mexico City, Mexico

Location

Synthon investigational site 515

Morelia, Mexico

Location

Synthon investigational site 547

Chisinau, Moldova

Location

Synthon investigational site 548

Chisinau, Moldova

Location

Synthon investigational site 549

Chisinau, Moldova

Location

Synthon investigational site 550

Chisinau, Moldova

Location

Synthon investigational site 244

Bialystok, Poland

Location

Synthon investigational site 240

Katowice, Poland

Location

Synthon investigational site 241

Katowice, Poland

Location

Synthon investigational site 242

Katowice, Poland

Location

Synthon investigational site 245

Katowice, Poland

Location

Synthon investigational site 247

Lodz, Poland

Location

Synthon investigational site 251

Lublin, Poland

Location

Synthon investigational site 243

Olsztyn, Poland

Location

Synthon investigational site 248

Poznan, Poland

Location

Synthon investigational site 250

Szczecin, Poland

Location

Synthon investigational site 246

Warsaw, Poland

Location

Synthon investigational site 249

Wroclaw, Poland

Location

Synthon investigational site 260

Bucharest, Romania

Location

Synthon investigational site 262

Bucharest, Romania

Location

Synthon investigational site 263

Bucharest, Romania

Location

Synthon investigational site 264

Bucharest, Romania

Location

Synthon investigational site 265

Bucharest, Romania

Location

Synthon investigational site 266

Cluj-Napoca, Romania

Location

Synthon investigational site 267

Timișoara, Romania

Location

Synthon investigational site 438

Arkhangelsk, Russia

Location

Synthon investigational site 435

Barnaul, Russia

Location

Synthon investigational site 437

Belgorod, Russia

Location

Synthon investigational site 445

Kaluga, Russia

Location

Synthon investigational site 427

Kazan', Russia

Location

Synthon investigational site 432

Kemerovo, Russia

Location

Synthon investigational site 447

Kirov, Russia

Location

Synthon investigational site 446

Lipetsk, Russia

Location

Synthon investigational site 571

Moscow, Russia

Location

Synthon investigational site 428

Nizhny Novgorod, Russia

Location

Synthon investigational site 429

Nizhny Novgorod, Russia

Location

Synthon investigational site 434

Novosibirsk, Russia

Location

Synthon investigational site 442

Novosibirsk, Russia

Location

Synthon investigational site 444

Penza, Russia

Location

Synthon investigational site 433

Pyatigorsk, Russia

Location

Synthon investigational site 421

Saint Petersburg, Russia

Location

Synthon investigational site 426

Saint Petersburg, Russia

Location

Synthon investigational site 430

Saint Petersburg, Russia

Location

Synthon investigational site 440

Saint Petersburg, Russia

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Synthon investigational site 424

Samara, Russia

Location

Synthon investigational site 420

Smolensk, Russia

Location

Synthon investigational site 422

Tomsk, Russia

Location

Synthon investigational site 441

Tver', Russia

Location

Synthon investigational site 425

Tyumen, Russia

Location

Synthon investigational site 423

Ufa, Russia

Location

Synthon investigational site 431

Yekaterinburg, Russia

Location

Synthon investigational site 450

Belgrade, Serbia

Location

Synthon investigational site 451

Belgrade, Serbia

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Synthon investigational site 453

Kragujevac, Serbia

Location

Synthon investigational site 452

Novi Sad, Serbia

Location

Synthon investigational site 501

Cape Town, South Africa

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Synthon investigational site 505

Durban, South Africa

Location

Synthon investigational site 502

Pretoria, South Africa

Location

Synthon investigational site 474

Cherkassy, Ukraine

Location

Synthon investigational site 459

Chernihiv, Ukraine

Location

Synthon investigational site 463

Chernivtsi, Ukraine

Location

Synthon investigational site 458

Dnipro, Ukraine

Location

Synthon investigational site 472

Dnipro, Ukraine

Location

Synthon investigational site 464

Donetsk, Ukraine

Location

Synthon investigational site 468

Donetsk, Ukraine

Location

Synthon investigational site 495

Ivano-Frankivsk, Ukraine

Location

Synthon investigational site 461

Kharkiv, Ukraine

Location

Synthon investigational site 469

Kharkiv, Ukraine

Location

Synthon investigational site 455

Kyiv, Ukraine

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Synthon investigational site 456

Kyiv, Ukraine

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Synthon investigational site 496

Kyiv, Ukraine

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Synthon investigational site 473

Lutsk, Ukraine

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Synthon investigational site 462

Lviv, Ukraine

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Synthon investigational site 466

Lviv, Ukraine

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Synthon investigational site 497

Lviv, Ukraine

Location

Synthon investigational site 498

Mariupol, Ukraine

Location

Synthon investigational site 457

Odesa, Ukraine

Location

Synthon investigational site 470

Poltava, Ukraine

Location

Synthon investigational site 471

Uzhhorod, Ukraine

Location

Synthon investigational site 465

Vinnytsia, Ukraine

Location

Synthon investigational site 460

Zhytomyr, Ukraine

Location

Synthon investigational site 284

Sheffield, United Kingdom

Location

Synthon investigational site 281

Stoke-on-Trent, United Kingdom

Location

Synthon investigational site 283

Torquay, United Kingdom

Location

Synthon investigational site 280

Truro, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26458034 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: VP Clinical Development
• Organization: Synthon BV

clinicaltrials@synthon.com

+3124727700

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 9, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: December 29, 2016
• Results First Posted: October 31, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

RO (7); ES (2); BU (8); UA (23); IT (2); SE (4); GE (5); CZ (7); ZA (3); RU (26); BE (7); GB (4); MO (4); BO (3); CR (4); DE (1); US (7); ME (4); PL (12)