An Open-Label, Multicenter, Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection

Teva Branded Pharmaceutical Products R&D, Inc.0 sites147 target enrollmentJuly 2009

ConditionsRelapsing Remitting Multiple Sclerosis

InterventionsGlatiramer Acetate Experimental Glatiramer Acetate

DrugsGlatiramer Acetate Experimental Glatiramer Acetate

Overview

Phase: Phase 3
Intervention: Glatiramer Acetate
Conditions: Relapsing Remitting Multiple Sclerosis
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Enrollment: 147
Primary Endpoint: Subject-reported Pain Associated Immediately After Each Injection
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

November 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

F1 Glatiramer acetate 20mg/1.0ml

Intervention: Glatiramer Acetate

F2 Glatiramer acetate 20mg/0.5ml

Intervention: Experimental Glatiramer Acetate

Outcomes

Primary Outcomes

Subject-reported Pain Associated Immediately After Each Injection

Time Frame: 5 weeks of injections

A visual analog scale (VAS) was used for subjective characteristics that cannot be directly measured. Respondents specified their level of agreement to a statement by indicating a position along a continuous line between two end-points. The VAS scale used 0 mm to represent "no pain" and up to 100 mm to represent "worst possible pain;" subjects drew a continuous line to represent their level of pain.