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

This study is ongoing, but not recruiting participants.

First Received on September 12, 2005. Last Updated on November 14, 2011 History of Changes

Sponsor:	Teva Pharmaceutical Industries
Information provided by (Responsible Party):	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00203021

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 IV

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:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Copolymer 1

U.S. FDA Resources

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:	July 2012
Estimated Primary Completion Date:	July 2012 (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

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

Locations

United States, California
Teva Investigational Site 009
Los Angeles, California, United States
United States, Connecticut
Teva Investigational Site 008
New Haven, Connecticut, United States
United States, Florida
Teva Investigational Site 001
West Palm Beach, Florida, 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, 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:	01-9004
Study First Received:	September 12, 2005
Last Updated:	November 14, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012