NCT01167426

Evaluation of Two Glatiramer Acetate (GA) Formulations in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients

An Open-Label, Multicenter Study Evaluating Patient Injection Satisfaction With Two Formulations of Glatiramer Acetate (GA) Using Autoject 2 as the Subcutaneous Injection Delivery Method.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Teva Neuroscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Glatiramer Acetate 20 mg/0.5 mL	20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe.
DRUG	Glatiramer acetate 20 mg/0.5 mL	20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device.

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2010-07-22
• Last updated: 2013-10-17
• Results posted: 2013-10-17