safety and tolerability of glatiramer acetate

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: this is an open-label, randomized, multi-center, parallel-arm study to assess the safety and tolerability of a daily dose of glatiramer acetate (ga) 40 mg/ml three times a week (tiw) administered subcutaneously (sc) as compared to ga 20 mg/ml every day (qd) administered sc.

the study will comprise of a core study and an extension phase. during the core study, subjects will be evaluated at study sites for 5 scheduled visits at months: -1 (screening), 0 (baseline), 1, 2, and 4 (termination/early termination). subjects who complete all scheduled visits will have final procedures and assessments performed at the final visit (month 4, termination visit). subjects who withdraw from the study before completing the 4 months evaluation period will have early termination (et) procedures and assessments performed at their final visit. during the extension phase, all subjects will be offered to continue treatment with ga 40 mg/ml tiw. subjects will be evaluated every 4 months until this dose strength is commercially available for the treatment of relapsing-remitting multiple sclerosis (rrms) patients or until the development of this ga dose regimen is stopped by the sponsor, the last visit of this phase will be called termination/et-extension visit.

Eligibility criteria:
inclusion criteria: 1. men or women at least 18 years of age or older 2. subjects must have a confirmed and documented rrms diagnosis as defined by the revised mcdonald criteria, with relapse onset disease or a relapsing-remitting disease course 3. subjects must be ambulatory with a kurtzke expanded disability status scale (edss) score of 0-5.5 in both the screening and baseline visits. 4. subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment \[intravenous (iv), intramuscular (im) and/or per os (po)\] or adrenocorticotrophic hormone (acth), 60 days prior to randomization. 5. subjects must be treated with glatiramer acetate (ga) 20mg/ml qd sc injection for a minimum of 6 months prior to screening. 6. women of child-bearing potential must practice an acceptable method of birth control \[acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or a double-barrier method (condom or diaphragm with spermicide)\]. 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 exclusion criteria: 1. subject has any contraindication to glatiramer acetate therapy 2. subjects with progressive forms of multiple sclerosis (ms). 3. subjects with neuromyelitis optica (nmo). 4. use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening. 5. concomitant use of other disease modifying drug for ms ((fingolimod (gilenya®), dimethyl fumarate (tecfidera®), teriflunomide (aubagio®) or intravenous immunoglobulin (ivig)) within 6 months prior to screening 6. previous use of mitoxantrone, cladribine, alemtuzumab, rituximab, natalizumab. 7. chronic (more than 30 consecutive days) systemic (iv, po or im) corticosteroid treatment within 6 months prior to screening visit. 8. previous total body irradiation or total lymphoid irradiation. 9. previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation. 10. pregnancy or breastfeeding. 11. 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 and abnormal laboratory tests. 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. 12. subjects who underwent endovascular treatment for chronic cerebrospinal venous insufficiency (ccsvi). 13. employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals -

Keywords: multiple sclerosis relapsing-remitting multiple sclerosis glatiramer acetate glatiramer