Safety of New Formulation of Glatiramer Acetate

Last updated: February 2, 2017
Sponsor: Teva Pharmaceutical Industries
Overall Status: Completed

Phase

3

Condition

Memory Loss

Multiple Sclerosis

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT00947752
PM033
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 daysutilizing 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 orcontinue 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 bewilling 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 adjunctiveLISR management techniques

  • Willing and able to provide written informed consent

Exclusion

Exclusion Criteria:

  • Currently using or treated with another immunomodulating therapy (IMT) in conjunctionwith GA in the 30 days prior to screening for this study

  • Currently using intermittent or pulse courses of corticosteroids by any route ofadministration in the 30 days prior to screening for this study. (Corticosteroids areprohibited for the duration of the study.)

  • Currently using an investigational drug or using treatment with any otherinvestigational 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 fivesites 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 forthis research, as determined by the Investigator

  • Previous participation in this study

Study Design

Total Participants: 147
Study Start date:
July 01, 2009
Estimated Completion Date:
November 30, 2009