An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) (GLOW)

Teva Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Drug: Placebo; Drug: Glatiramer Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01578785

GA-MS-302

2011-005550-57 (EudraCT Number)

Details and patient eligibility

About

This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).

Full description

Approximately 1400 participants were planned for this study, however only 178 were enrolled prior to early termination.

Enrollment: 178 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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178 participants in 2 patient groups, including a placebo group

Glatiramer Acetate

Experimental group

Description:

Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.

Treatment:

Drug: Glatiramer Acetate

Placebo

Placebo Comparator group

Description:

Placebo solution in prefilled syringe for subcutaneous injection once daily.

Treatment:

Drug: Placebo