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Copaxone® Study to Follow Patients From the First Original Study for Safety and Effectiveness.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00203021
First received: September 12, 2005
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

Patients have scheduled visits every 3 months to assess Copaxone safety and their Multiple Sclerosis status.


Condition Intervention Phase
Multiple Sclerosis
Drug: Glatiramer acetate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone®

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • EDSS for efficacy every 6 months and adverse events for safety every 3 months. [ Time Frame: 17 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MRI data & Quality Of Life data periodically during study [ Time Frame: 17 years ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: July 1994
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glatiramer Acetate
Open label treatment
Drug: Glatiramer acetate
Glatiramer acetate 20mg and mannitol 40mg contained in same pre-filled syringe; subcutaneous injection once daily.
Other Name: Copaxone®

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have participated (been randomized) in the Copaxone Double-Blind placebo controlled study (Protocol 01-9001).
  • Gender: Patients may be male or female. Women of childbearing potential must practice an acceptable method of birth control.
  • Patients must meet the criteria of clinically definite MS as defined by Poser.5
  • The patient's signs and symptoms cannot be better explained by another disease process.
  • Patients must sign an approved informed consent prior to initiating the study.
  • Patients must be psychologically and physically stable to participate in the trial as judged by the investigator.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Medical or psychiatric conditions that affect the patient's ability to give informed consent or complete the study.
  • Inability to self-administer subcutaneous medication or lack of another responsible individual to administer the study preparation daily.
  • Use of Interferons, experimental MS therapies, or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine), or total lymphoid irradiation within 30 days of study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203021

Locations
United States, California
Teva Investigational Site 004
Los Angeles, California, United States
Teva Investigational Site 009
Los Angeles, California, United States
United States, Connecticut
Teva Investigational Site 008
New Haven, Connecticut, United States
United States, Maryland
Teva Investigational Site 005
Baltimore, Maryland, United States
United States, Michigan
Teva Investigational Site 003
Detroit, Michigan, United States
United States, New Mexico
Teva Investigational Site 002
Albuquerque, New Mexico, United States
United States, New York
Teva Investigational Site 007
Rochester, New York, United States
United States, Pennsylvania
Teva Investigational Site 001
Philadelphia, Pennsylvania, United States
United States, Texas
Teva Investigational Site 010
Houston, Texas, United States
United States, Utah
Teva Investigational Site 006
Salt Lake City, Utah, United States
United States, Wisconsin
Teva Investigational Site 011
Madison, Wisconsin, United States
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Kenneth Johnson, MD University of Maryland
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00203021     History of Changes
Other Study ID Numbers: GA-9004
Study First Received: September 12, 2005
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014