Efficacy and Safety of GTR in Comparison to Copaxone®
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Glatiramer Acetate (GTR); Glatiramer Acetate (Copaxone®); Placebo
Intervention description: Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2); Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2); Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 794.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis,; Relapsing-Remitting Multiple Sclerosis,; glatiramer acetate,; MRI,; lesions,; MS relapse rate,; Copaxone

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
    

Eligibility 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.