AzTrials
AzTrials

Multiple SclerosisPhase 3GATENCT01489254

Efficacy and Safety of GTR in Comparison to Copaxone®

A Phase 3 study testing Glatiramer Acetate (GTR) and Glatiramer Acetate (Copaxone®) in people with Multiple Sclerosis, run by Synthon BV at 133 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Glatiramer Acetate (GTR) and Glatiramer Acetate (Copaxone®)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
794 participants
Where
133 sitesin 19 countries
Study dates
Oct 2011to Jan 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 28Show fewer
  • 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.

Trial locations and contacts

133 sites in 19 countries.

133 sites in 19 countries

Russia26 sites

  • Synthon investigational site 438

    Arkhangelsk

  • Synthon investigational site 435

    Barnaul

  • Synthon investigational site 437

    Belgorod

  • Synthon investigational site 445

    Kaluga

  • Synthon investigational site 427

    Kazan'

  • Synthon investigational site 432

    Kemerovo

  • Synthon investigational site 447

    Kirov

  • Synthon investigational site 446

    Lipetsk

  • Synthon investigational site 571

    Moscow

  • Synthon investigational site 428

    Nizhny Novgorod

  • Synthon investigational site 429

    Nizhny Novgorod

  • Synthon investigational site 434

    Novosibirsk

  • Synthon investigational site 442

    Novosibirsk

  • Synthon investigational site 444

    Penza

  • Synthon investigational site 433

    Pyatigorsk

  • Synthon investigational site 421

    Saint Petersburg

  • Synthon investigational site 426

    Saint Petersburg

  • Synthon investigational site 430

    Saint Petersburg

  • Synthon investigational site 440

    Saint Petersburg

  • Synthon investigational site 424

    Samara

  • Synthon investigational site 420

    Smolensk

  • Synthon investigational site 422

    Tomsk

  • Synthon investigational site 441

    Tver'

  • Synthon investigational site 425

    Tyumen

  • Synthon investigational site 423

    Ufa

  • Synthon investigational site 431

    Yekaterinburg

Other trials in Russia

Ukraine23 sites

  • Synthon investigational site 474

    Cherkassy

  • Synthon investigational site 459

    Chernihiv

  • Synthon investigational site 463

    Chernivtsi

  • Synthon investigational site 458

    Dnipro

  • Synthon investigational site 472

    Dnipro

  • Synthon investigational site 464

    Donetsk

  • Synthon investigational site 468

    Donetsk

  • Synthon investigational site 495

    Ivano-Frankivsk

  • Synthon investigational site 461

    Kharkiv

  • Synthon investigational site 469

    Kharkiv

  • Synthon investigational site 455

    Kyiv

  • Synthon investigational site 456

    Kyiv

  • Synthon investigational site 496

    Kyiv

  • Synthon investigational site 473

    Lutsk

  • Synthon investigational site 462

    Lviv

  • Synthon investigational site 466

    Lviv

  • Synthon investigational site 497

    Lviv

  • Synthon investigational site 498

    Mariupol

  • Synthon investigational site 457

    Odesa

  • Synthon investigational site 470

    Poltava

  • Synthon investigational site 471

    Uzhhorod

  • Synthon investigational site 465

    Vinnytsia

  • Synthon investigational site 460

    Zhytomyr

Other trials in Ukraine

Poland12 sites

  • Synthon investigational site 244

    Bialystok

  • Synthon investigational site 240

    Katowice

  • Synthon investigational site 241

    Katowice

  • Synthon investigational site 242

    Katowice

  • Synthon investigational site 245

    Katowice

  • Synthon investigational site 247

    Lodz

  • Synthon investigational site 251

    Lublin

  • Synthon investigational site 243

    Olsztyn

  • Synthon investigational site 248

    Poznan

  • Synthon investigational site 250

    Szczecin

  • Synthon investigational site 246

    Warsaw

  • Synthon investigational site 249

    Wroclaw

Other trials in Poland

Bulgaria8 sites

  • Synthon investigational site 204

    Pleven

  • Synthon investigational site 207

    Pleven

  • Synthon investigational site 206

    Plovdiv

  • Synthon investigational site 202

    Sofia

  • Synthon investigational site 203

    Sofia

  • Synthon investigational site 205

    Sofia

  • Synthon investigational site 208

    Sofia

  • Synthon investigational site 201

    Varna

Other trials in Bulgaria

United States7 sites

  • Synthon investigational site 106

    Cleveland, Ohio

  • Synthon investigational site 135

    Dayton, Ohio

  • Synthon investigational site 107

    Elk Grove Village, Illinois

  • Synthon investigational site 112

    Irvine, California

  • Synthon investigational site 120

    Port Charlotte, Florida

  • Synthon investigational site 141

    Raleigh, North Carolina

  • Synthon investigational site 130

    Sunrise, Florida

Other trials in United States

Belarus7 sites

  • Synthon investigational site 401

    Bitebsk

  • Synthon investigational site 403

    Grodno

  • Synthon investigational site 402

    Homyel

  • Synthon investigational site 404

    Minsk

  • Synthon investigational site 407

    Minsk

  • Synthon investigational site 408

    Minsk

  • Synthon investigational site 405

    Vitebsk

Other trials in Belarus

Czechia7 sites

  • Synthon investigational site 211

    Brno

  • Synthon investigational site 217

    Brno

  • Synthon investigational site 210

    Olomouc

  • Synthon investigational site 212

    Ostrava

  • Synthon investigational site 215

    Prague

  • Synthon investigational site 216

    Prague

  • Synthon investigational site 214

    Teplice

Other trials in Czechia

Romania7 sites

  • Synthon investigational site 260

    Bucharest

  • Synthon investigational site 262

    Bucharest

  • Synthon investigational site 263

    Bucharest

  • Synthon investigational site 264

    Bucharest

  • Synthon investigational site 265

    Bucharest

  • Synthon investigational site 266

    Cluj-Napoca

  • Synthon investigational site 267

    Timișoara

Other trials in Romania

Georgia5 sites

  • Synthon investigational site 526

    Tbilisi

  • Synthon investigational site 527

    Tbilisi

  • Synthon investigational site 528

    Tbilisi

  • Synthon investigational site 529

    Tbilisi

  • Synthon investigational site 530

    Tbilisi

Other trials in Georgia

Croatia4 sites

  • Synthon investigational site 477

    Osijek

  • Synthon investigational site 475

    Zagreb

  • Synthon investigational site 476

    Zagreb

  • Synthon investigational site 478

    Zagreb

Other trials in Croatia

Mexico4 sites

  • Synthon investigational site 516

    Guadalajara

  • Synthon investigational site 512

    Mexico City

  • Synthon investigational site 514

    Mexico City

  • Synthon investigational site 515

    Morelia

Other trials in Mexico

Moldova4 sites

  • Synthon investigational site 547

    Chisinau

  • Synthon investigational site 548

    Chisinau

  • Synthon investigational site 549

    Chisinau

  • Synthon investigational site 550

    Chisinau

Other trials in Moldova

Serbia4 sites

  • Synthon investigational site 450

    Belgrade

  • Synthon investigational site 451

    Belgrade

  • Synthon investigational site 453

    Kragujevac

  • Synthon investigational site 452

    Novi Sad

Other trials in Serbia

United Kingdom4 sites

  • Synthon investigational site 284

    Sheffield

  • Synthon investigational site 281

    Stoke-on-Trent

  • Synthon investigational site 283

    Torquay

  • Synthon investigational site 280

    Truro

Other trials in United Kingdom

Bosnia and Herzegovina3 sites

  • Synthon investigational site 486

    Banja Luka

  • Synthon investigational site 487

    Sarajevo

  • Synthon investigational site 488

    Tuzla

Other trials in Bosnia and Herzegovina

South Africa3 sites

  • Synthon investigational site 501

    Cape Town

  • Synthon investigational site 505

    Durban

  • Synthon investigational site 502

    Pretoria

Other trials in South Africa

Estonia2 sites

  • Synthon investigational site 297

    Kohtla-Järve

  • Synthon investigational site 296

    Tallinn

Other trials in Estonia

Italy2 sites

  • Synthon investigational site 234

    Coppito

  • Synthon investigational site 235

    Naples

Other trials in Italy

Germany1 site

  • Synthon investigational site 227

    Jena

Other trials in Germany

About this study

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

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

Read the 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.

Being tested
Glatiramer Acetate (GTR), Glatiramer Acetate (Copaxone®), Placebo
Keywords
Multiple Sclerosis,, Relapsing-Remitting Multiple Sclerosis,, glatiramer acetate,, MRI,, lesions,, MS relapse rate,, Copaxone
Medical subject headings
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glatiramer Acetate (GTR)Drug

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

  • 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)

  • PlaceboDrug

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

Study groups in NCT01489254
Study groupRoleWhat they receive
GTRExperimentalDrug
Receives: Drug: Glatiramer Acetate (GTR)
Copaxone®Active comparatorDrug
Receives: Drug: Glatiramer Acetate (Copaxone®)
PlaceboPlacebo comparatorDrug
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
794 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01489254
Sponsor's protocol ID
GTR001
Other IDs
2011-000888-27
Acronym
GATE
Status last verified
Nov 2016
First submitted
8 Dec 2011
Last updated
29 Dec 2016
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 26458034

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glatiramer Acetate (GTR) and Glatiramer Acetate (Copaxone®) in people with Multiple Sclerosis, run by Synthon BV at 133 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in Russia, Ukraine, Poland, Bulgaria, United States and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01489254, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in