Conditions: Multiple Sclerosis
Keywords: Relapsing Remitting Multiple Sclerosis RRMS Clinically Isolated Syndrome CIS Copaxone glatiramer acetate Autoject 2
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 148
Healthy volunteers: no

Brief summary:
This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.

Detailed description:
The study will consist of a 2 week treatment period with participants injecting their current therapy of Copaxone 20 mg/1.0 mL glatiramer acetate utilizing an autoject 2. All participants will then roll over to the new formulation of 20 mg/0.5 mL glatiramer acetate with an autoject 2 device for a 4 week treatment period. Patient satisfaction will be evaluated using an Experience Questionnaire throughout the study.

Arms:
arm 1: Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).

Interventions: intervention 1: Glatiramer Acetate 20 mg/0.5 mL intervention 2: Glatiramer acetate 20 mg/0.5 mL
Intervention descriptions: intervention 1: 20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe. intervention 2: 20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device.

Protocol document: