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: October 10, 2014
Last verified: June 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 133 Study Locations
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: October 10, 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
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014