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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Glatiramer acetate 20 mg/0.5 mL; Drug: Glatiramer Acetate 20 mg/0.5 mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT01167426

PM034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years of age with a diagnosis of Relapse Remitting Multiple Sclerosis (RRMS) or Clinically Isolated Syndrome (CIS)
• Currently injecting glatiramer acetate 20 mg/1.0 mL per day subcutaneously (SC) for a minimum of 90 days utilizing the autoject 2 for glass syringe for a minimum of 75% of daily injections
• Willing and able to complete all procedures and evaluations related to the study
• Willing to continue to follow usual injection site preparation and routine adjunctive local injection site reactions (LISR) management techniques
• Willing and able to provide written informed consent

Exclusion criteria

• Currently using or treated with another immunomodulating therapy (IMT) in conjunction with GA in the 30 days prior to screening for this study
• Currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study
• Pregnant or planning pregnancy or breastfeeding
• Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.) either currently or in the past 30 days prior to screening for this study
• Any other medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the Investigator
• Unwilling to perform all daily injections with an autoject 2 device
• Previous participation in any study evaluating the new 20 mg/0.5 mL formulation

Trial design

148 participants in 1 patient group

20 mg/0.5 mL Glatiramer Acetate

Active Comparator group

Description:

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).

Treatment:

Drug: Glatiramer Acetate 20 mg/0.5 mL