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Efficacy and Safety of GTR in Comparison to Copaxone®

Information source: Synthon BV
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Glatiramer Acetate (GTR) (Drug); Glatiramer Acetate (Copaxone®) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Synthon BV

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

Clinical Details

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

Primary outcome: The number of Gadolinium enhancing lesions during months 7-9

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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Synthon investigational site 401, Bitebsk, Belarus

Synthon investigational site 402, Gomel, Belarus

Synthon investigational site 403, Grodno, Belarus

Synthon investigational site 404, Minsk, Belarus

Synthon investigational site 407, Minsk, Belarus

Synthon investigational site 408, Minsk, Belarus

Synthon investigational site 405, Vitebsk, Belarus

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

Synthon investigational site 204, Pleven, Bulgaria

Synthon investigational site 207, Pleven, Bulgaria

Synthon investigational site 206, Plovdiv, Bulgaria

Synthon investigational site 202, Sofia, Bulgaria

Synthon investigational site 203, Sofia, Bulgaria

Synthon investigational site 205, Sofia, Bulgaria

Synthon investigational site 208, Sofia, Bulgaria

Synthon investigational site 201, Varna, Bulgaria

Synthon investigational site 477, Osijek, Croatia

Synthon investigational site 475, Zagreb, Croatia

Synthon investigational site 476, Zagreb, Croatia

Synthon investigational site 478, Zagreb, Croatia

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

Synthon investigational site 297, Kohtla-Jarve, Estonia

Synthon investigational site 296, Tallinn, Estonia

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

Synthon investigational site 227, Jena, Germany

Synthon investigational site 234, Coppito, Italy

Synthon investigational site 235, Naples, Italy

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

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

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

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

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 428, Nizhniy Novgorod, Russian Federation

Synthon investigational site 429, Nizhniy Novgorod, Russian Federation

Synthon investigational site 434, Novosibirsk, Russian Federation

Synthon investigational site 442, 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 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, 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

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

Synthon investigational site 501, Cape Town, South Africa

Synthon investigational site 505, Durban, South Africa

Synthon investigational site 502, Pretoria, South Africa

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 455, Kyiv, Ukraine

Synthon investigational site 456, 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

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

Synthon investigational site 112, Irvine, California, United States

Synthon investigational site 120, Port Charlotte, Florida, United States

Synthon investigational site 130, Sunrise, Florida, United States

Synthon investigational site 107, Elk Grove Village, Illinois, United States

Synthon investigational site 141, Raleigh, North Carolina, United States

Synthon investigational site 106, Cleveland, Ohio, United States

Synthon investigational site 135, Dayton, Ohio, United States

Additional Information

Starting date: October 2011
Last updated: March 18, 2015

Page last updated: August 20, 2015

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