Copaxone® Study to Follow Patients From the First Original Study for Safety and Effectiveness. - Full Text View

Sponsored by:	Teva Pharmaceutical Industries
Information provided by:	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 Drug: mannitol	Phase IV

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Mannitol Copolymer 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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®

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
1: Experimental open label treatment	Drug: glatiramer acetate 20mg, subcutaneous injection once daily, pre-filled syringe. Glatiramer acetate and mannitol contained in same pre-filled syringe. Drug: mannitol 40mg, subcutaneous injection once daily, pre-filled syringe. Glatiramer acetate and mannitol contained in same pre-filled syringe.

Detailed Description:

Open label study to evaluate the safety of Copaxone and its effect on the neurologic course of patients with relapsing-remitting MS. Copaxone® Injection, a clear, colorless to slightly yellow, sterile, non-pyrogenic solution for subcutaneous injection is be self-injected daily by patients.

After all eligibility criteria for each patient was met treatment commenced for that patient. Patients will be evaluated every three months for safety and every six months for change in neurological status. Neurological examinations include Functional system evaluation, Kurtzke, Expanded Disability Status score, Ambulation Index.

The eleven University Hospital centers in the United States which participated in the Double-Blind Study (Protocol 01-9001) collaborate in the conduct of the study.

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
UCLA Neurological Services
Los Angeles, California, United States, 90095
USC Department of Neurology
Los Angeles, California, United States, 90033
United States, Connecticut
Yale MS Research Center
New Haven, Connecticut, United States, 06520
United States, Maryland
The Maryland Center for M.S.
Baltimore, Maryland, United States, 21201
United States, Michigan
University Health Center 8B
Detroit, Michigan, United States, 48201
United States, New Mexico
UNM School of Medicine
Albuquerque, New Mexico, United States, 87131
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Pennsylvania
Univ. of PA Medical Center, Dept. of Neuro.
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas HSC-Houston
Houston, Texas, United States, 77030
United States, Utah
VA Medical Center
Salt Lake City, Utah, United States, 84148
United States, Wisconsin
UW Hospital & Clinic
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

Kenneth Johnson, MD

University of Maryland

More Information

No publications provided

Responsible Party:	Teva Neuroscience ( J. Michael Nicholas, Ph.D. )
Study ID Numbers:	01-9004
Study First Received:	September 12, 2005
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00203021 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Demyelinating Diseases
Immunologic Factors
Diuretics
Adjuvants, Immunologic
Sclerosis
Cardiovascular Agents

Immunosuppressive Agents
Copolymer 1
Multiple Sclerosis
Mannitol
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Immune System Diseases
Diuretics, Osmotic
Physiological Effects of Drugs
Nervous System Diseases
Diuretics
Adjuvants, Immunologic
Sclerosis
Cardiovascular Agents

Immunosuppressive Agents
Pharmacologic Actions
Copolymer 1
Multiple Sclerosis
Pathologic Processes
Natriuretic Agents
Mannitol
Therapeutic Uses
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009