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

NCT01167426 | Completed Phase 3 Results

• 1 other identifier: PM034
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Relapsing Remitting Multiple Sclerosis; RRMS; Clinically Isolated Syndrome; CIS; Copaxone; glatiramer acetate; Autoject 2

Outcome Measures

Primary Outcomes (1)

• Change From Week 2 to Week 6 in Composite Score of Patient Satisfaction With Injection Experience

  The Satisfaction with Injection Experience questionnaire consists of 5 questions where participants are asked to rate their injection experience over the past 2 weeks on ease of use, bother, acceptability, confidence to inject and satisfaction. The response options range from "strongly disagree" (score = 1) to "strongly agree" (score = 5). The composite score of Satisfaction with Injection Experience is defined as the mean of the five Likert questions. The composite score ranges from 1.0 to 5.0, with a score of 5.0 representing the most satisfaction with injection experience and a score of 1.0 representing the least satisfaction with injection experience.

  Week 2 (prior to first injection with 20 mg/0.5 mL formulation), Week 6 (after 4 weeks of treatment with 20 mg/0.5 mL formulation).

Secondary Outcomes (1)

• Patient Injection Experience Preference

  Week 4

Study Arms (1)

20 mg/0.5 mL Glatiramer Acetate

ACTIVE COMPARATOR

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).

Drug: Glatiramer Acetate 20 mg/0.5 mL

Interventions

Glatiramer acetate 20 mg/0.5 mL DRUG

20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe.

Also known as: Copaxone®

20 mg/0.5 mL Glatiramer Acetate

Eligibility Criteria

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

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Teva Neuroscience, Inc.: lead

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

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

Results Point of Contact

• Title: Thomas Smith, MD
• Organization: Teva Pharmaceuticals Medical Affairs

tom.smith@tevapharm.com

816-508-5128

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: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 22, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 17, 2013
• Results First Posted: October 17, 2013

Record last verified: 2012-08