GLOWA Multinational, Multicenter, Randomized, Parallel Group, Double Blind, Placebo Controlled Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate 20mg/0.5ml New Formulation Administered Daily by Subcutaneous Injection
Glatiramer Acetate
+ Placebo
Autoimmune Diseases+5
+ Demyelinating Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: March 1, 2012
Actual date on which the first participant was enrolled.Approximately 1400 participants were planned for this study, however only 178 were enrolled prior to early termination.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.178 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Subjects must meet all inclusion criteria in order to be eligible for the study: * Subjects must have a confirmed and documented multiple sclerosis (MS) diagnosis as defined by the 2010 Revised McDonald criteria \[Ann Neurol 2011: 69:292-302\], with a relapsing-remitting disease course. * Subjects must be ambulatory with a Kurtzke's Expanded Disability Status Scale (EDSS) score of 0-5.5 in both screening and baseline visits. * Subjects must be in a relapse-free, stable neurological condition and free of corticosteroid treatment \[intravenous (IV), intramuscular (IM) and/or by mouth (PO)\] or ACTH (adrenocorticotropic hormone) 30 days prior to screening (Month-1) and between screening and baseline (Month 0) visits. * Subjects must have experienced one of the following: * At least one documented relapse in the 12 months prior to screening, * At least two documented relapses in the 24 months prior to screening, * One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in a magnetic resonance imaging (MRI) performed within 12 months prior to screening. * Subjects must be between 18 and 55 years of age, inclusive. * Women of child-bearing potential must practice an acceptable method of birth control \[acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or a double-barrier method (condom or diaphragm with spermicide)\]. * Subjects must be able to sign and date a written informed consent prior to entering the study. * Subjects must be willing and able to comply with the protocol requirements for the duration of the study. Exclusion Criteria: Any of the following conditions will exclude the subject from entering the study: * Subjects with progressive forms of MS. * Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening. * Use of immunosuppressive agents (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit. * Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening. * Use of cladribine within 2 years prior to screening. * Previous treatment with immunomodulators \[including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg)\] within 2 months prior to screening. * Previous use of glatiramer acetate (GA) or any other glatiramoid. * Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit. * Previous total body irradiation or total lymphoid irradiation. * Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation. * Pregnancy or breastfeeding. * 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. * A known history of sensitivity to Gadolinium. * Glomerular filtration rate (GFR) ≤ 60 mL/minute at the screening visit * Inability to successfully undergo MRI scanning. * A known drug hypersensitivity to Mannitol. * Subjects who underwent endovascular treatment for chronic cerebrospinal venous insufficiency (CCSVI).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 169 locations
Teva Investigational Site 68003
Minsk, BelarusTeva Investigational Site 68005
Minsk, BelarusTeva Investigational Site 68006
Minsk, Belarus