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Efficacy and Safety of GTR in Comparison to Copaxone® | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety of GTR in Comparison to Copaxone®

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

NCT01489254•Synthon BV

View on ClinicalTrials.gov

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

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

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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:
+18 more criteria

Locations (133)

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

Synthon investigational site 401

Bitebsk, Belarus

Synthon investigational site 403

Grodno, Belarus

Synthon investigational site 402

Homyel, Belarus

Key Dates

Start Date

October 1, 2011

Primary Completion Date

January 1, 2015

Completion Date

January 1, 2015

Last Updated

December 29, 2016

Enrollment

794

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

Glatiramer Acetate (GTR)

DRUG

Glatiramer Acetate (Copaxone®)

DRUG

Placebo

DRUG

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of GTR in Comparison to Copaxone®

Inclusion Criteria

Exclusion Criteria

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