Relapsing remitting multiple sclerosis MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: glatiramer acetate
Product Code: GTR
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: glatiramer acetate
CAS Number: 147245-92-9
Current Sponsor cod
Sponsors
Synthon BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to sign written Informed Consent; 2. Female and male subjects aged 18-55 years inclusive at the time of Informed Consent signing; 3. Diagnosis of RRMS according to the revised McDonald criteria 4.Screening Expanded Disability Status Scale (EDSS) score of 0.0 up to and including 5.5; 5. Neurologically stable with no evidence of relapse within 30 days prior to baseline assessments. 6. Experienced at least 1 relapse in the year before first screening assessment; 7. 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); 8. 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 immune-modulatory treatment, or a screening MRI showing maximally 15 T1-GdE lesions; 9. 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; 10. Female subjects of childbearing potential must agree to practice appropriate contraceptive methods as assessed by the investigator. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 750 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any life-threatening, medically unstable or otherwise clinically significant condition or findings other than MS, in particular neoplastic disease, seizure disorders, or psychiatric disease; 2. Any clinically significant deviation from reference ranges in laboratory tests; 3. Positive laboratory test results for human immunodeficiency virus (HIV), HBsAg or HCV at screening; 4. Any significant deviation from reference ranges for hepatic function as defined by either AST (SGOT), ALT (SGPT), GGT, or AP elevated 3-fold or higher beyond the upper limit of the reference range or total bilirubin elevated 2-fold or higher beyond the upper limit of the reference range (in case of Gilbert’s Syndrome, a joint documented decision will be made between the investigator and the Medical Officer); 5. 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); 6. Having been treated with or having received a. 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; b. within one year before screening: • mitoxantrone, but subject cannot be enrolled when mitoxantrone was taken at a cumulative lifetime dosing above 100 mg/m2; c. 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); d. within 3 months before screening: • azathioprine, methotrexate; • plasma exchange; • any other experimental intervention, in particular experimental drugs; e. within 1 month before screening: • Interferon-ß 1a or 1b; • short-term oral or injectable corticosteroids for treatment of a relapse; • short-term ACTH; 7. 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); 8. Pregnancy or breastfeeding; 9. Known hypersensitivity to gadolinium-containing products, glatiramer acetate or mannitol; 10. Having an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2; 11. 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; 12. Any reason why, in the investigator's opinion, the subject should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Blinded phase: • to compare the efficacy of GTR to Copaxone® based on MRI parameters • to compare the efficacy of GTR to Copaxone® based on the annualized relapse rate; • to compare the efficacy of GTR to Copaxone® based on the changes in EDSS; • to compare the efficacy of GTR to Copaxone® based on the percentage subjects free from disease activity at month 9; • to compare the percentage of subjects with anti-glatiramer antibodies after GTR and Copaxone® treatment. Open-label phase: • to evaluate efficacy, safety and tolerability of long-term (2-years) GTR treatment; • to evaluate efficacy, safety and tolerability of switching to GTR treatment after previous Copaxone® use.;Primary end point(s): The mean number of Gadolinium enhancing lesions. ;Timepoint(s) of evaluation of this end point: the months 7-9 after start of treatment;Main Objective: To demonstrate that the efficacy of Synthon’s glatiramer acetate (GTR) is equivalent to Copaxone® (TEVA) in subjects with relapsing remitting multiple sclerosis (RRMS) as measured by the number of gadolinium-enhancing lesions on T1-weighted MRIs during the months 7-9. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • MRI parameters; • Annualized relapse rate; • EDSS change from baseline; • Percentage subjects “Free from disease activity”; • Percentage of subjects with anti-glatiramer antibodies formation. ;Timepoint(s) of evaluation of this end point: as per trial objectives and trial flowchart, page 7 and 8 of protocol | — |
Countries
Belarus, Bulgaria, Croatia, Czech Republic, Estonia, Germany, Greece, Italy, Lithuania, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Operations
PSI CRO Czech Republic s.r.o.
Outcome results
None listed