Safety of New Formulation of Glatiramer Acetate

NCT00947752 | Completed Phase 3 Results

• 1 other identifier: PM033
• Study Type: interventional
• Target: 147
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis (RRMS); Glatiramer Acetate (GA)

Outcome Measures

Primary Outcomes (1)

• Subject-reported Pain Associated Immediately After Each Injection

  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.

  5 weeks of injections

Secondary Outcomes (1)

• Degree of Pain Within 5 Mins After Injection

  5 weeks of injections

Study Arms (2)

F1 Glatiramer acetate 20mg/1.0ml

ACTIVE COMPARATOR

Drug: Glatiramer Acetate

F2 Glatiramer acetate 20mg/0.5ml

EXPERIMENTAL

Drug: Experimental Glatiramer Acetate

Interventions

Glatiramer Acetate DRUG

Subjects received both doses once daily in a crossover fashion, for a total treatment duration of five weeks, including a one-week run-in period. Subject-reported injection pain was recorded in a daily diary.

Also known as: F1

F1 Glatiramer acetate 20mg/1.0ml

Experimental Glatiramer Acetate DRUG

GA 20 mg/0.5 mL

Also known as: F2

F2 Glatiramer acetate 20mg/0.5ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Related Links

• Visual Analog Scale definition

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Blinding in this study was not possible due to the subjects' ability to detect difference in the volume of each formulation. The lack of blinding was a known limitation.

Results Point of Contact

• Title: Thomas Smith, MD, VP, Medical Affairs
• Organization: Teva Neuroscience, Inc.

tom.smith@tevapharm.com

816-508-5000

Study Officials

• Tom Smith, MD

  Teva Neuroscience, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2009
• First Posted: July 28, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 14, 2017
• Results First Posted: June 9, 2011

Record last verified: 2017-02