Safety of New Formulation of Glatiramer Acetate (Song)

Teva Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Relapsing Remitting Multiple Sclerosis

Treatments

Drug: Experimental Glatiramer Acetate

Drug: Glatiramer Acetate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00947752

PM033

Details and patient eligibility

About

The purpose of this study is to compare pain associated with injections and injection-site reactions of the approved formulation of Glatiramer Acetate (GA) versus investigational formulation of GA. In addition, the investigators will evaluate the side effects of the two formulations of GA.

Enrollment

147 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects ≥ 18 years of age with a diagnosis of RRMS
Currently injecting GA 20mg/1.0mL per day subcutaneously (SC) for a minimum of 90 days utilizing the autoject®2 for glass syringe or by a manual injection technique
Willing to switch from autoject®2 for glass syringe to manual injection technique or continue with a manual injection technique during the course of the study
Willing and able to be trained on a seven site injection rotation. Subject must be willing to comply with a minimum five injection site rotation plan during the study
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 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 intermittent or pulse courses of corticosteroids by any route of administration in the 30 days prior to screening for this study. (Corticosteroids are prohibited for the duration of the study.)
Currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study
Presence or history of skin necrosis
Known extensive dermatological condition that could be a confounding factor
Pregnant or planning pregnancy or breastfeeding
Any physical condition that impairs ability to be injected at the minimum of five sites rotation
Not able or willing to complete a daily diary
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 subject unsuitable for this research, as determined by the Investigator
Previous participation in this study