Relapsing-remitting Multiple sclerosis (RRMS) 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: 20mg/0.5ml glatiramer acetate
Product Code: 20mg/0.5ml GA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: glatiramer acetate
CAS Number: 147245-92-9
Current Sponsor code
Sponsors
Teva Pharmaceutical Industries Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria, with a relapsing-remitting disease course. 2.Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline visits. 3.Subjects must be in a relapse-free, stable neurological condition and free of corticosteroid treatment or ACTH, 30 days prior to screening (Month -1) and between screening and baseline (Month 0) visits. 4.Subjects must have experienced one of the following: • At least one documented relapse in the 12 months prior to screening, or • At least two documented relapses in the 24 months prior to screening, or • One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening. 5.Subjects must be between 18 and 55 years of age, inclusive. 6.Women of child-bearing potential must practice an acceptable method of birth control. 7.Subjects must be able to sign and date a written informed consent prior to entering the study. 8.Subjects must be willing and able to comply with the protocol requirements for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with progressive forms of MS. 2. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening. 3. Use of immunosuppressive (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit. 4. Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening. 5. Use of cladribine within 2 years prior to screening. 6. Previous treatment with immunomodulators within 2 months prior to screening. 7. Previous use of GA or any other glatiramoid. 8. Chronic systemic corticosteroid treatment within 6 months prior to screening visit. 9. Previous total body irradiation or total lymphoid irradiation. 10. Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation. 11. Pregnancy or breastfeeding. 12. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests and chest X-ray. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment. 13. A known history of sensitivity to Gadolinium. 14. GFR = 60 mL/min/ 1.73m2 at the screening visit 15. Inability to successfully undergo MRI scanning. 16. A known drug hypersensitivity to Mannitol. 17. Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of Glatiramer Acetate (GA) injection 20 mg/0.5 ml administered daily compared to placebo in subjects with RRMS on the total number of confirmed relapses during the 12 month PC phase. This will be used to calculate the Annualized Relapse Rate during the PC phase per each arm.;Secondary Objective: To assess the effect of GA injection 20 mg/0.5ml administered daily compared to placebo in subjects with RRMS: - on the cumulative number of new/enlarging T2 lesions measured at Months 6 and 12 (end of PC phase). - on the cumulative number of Gd-enhancing lesions on T1-weighted images measured at Months 6 and 12 (end of PC phase). - on the development of brain atrophy as defined by the percent brain volume change from baseline to Month 12 (end of PC phase). ;Primary end point(s): The total number of confirmed relapses during the 12 months PC phase. This will be used to calculate the Annual Relapse Rate during the PC phase per each arm. ;Timepoint(s) of evaluation of this end point: Relapses will be confirmed/monitored throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - cumulative number of new/enlarging T2 lesions measured at Months 6 and 12 (End of the PC phase) - cumulative number of Gd-enhancing lesions on T1-weighted images measured at Month - percent brain volume change from baseline to Month 12 (end of PC phase). ;Timepoint(s) of evaluation of this end point: Following GFR evaluation, all subjects will undergo MRI scans at months 0 (13-7 days prior to baseline visit), Month 6 and Month 12 (end of PC phase) or ET. During an unscheduled visit the investigator will decide if an MRI scan is required. - The cumulative number of new/enlarging T2 lesions measured at Months 6 and 12 (end of PC phase). - The cumulative number of Gd-enhancing lesions on T1-weighted images measured at Months 6 and 12 (End of the PC phase). -The percent brain volume change from baseline to Month 12 (end of PC phase). | — |
Countries
Albania, Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Germany, Greece, Hungary, Latvia, Lithuania, Macedonia, the former Yugoslav Republic of, Mexico, Moldova, Republic of, Montenegro, Poland, Romania, Russian Federation, Serbia, Ukraine, United States
Contacts
Public ContactClinical trial information desk
Teva Pharma GmbH
Outcome results
None listed