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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00203021
Recruitment Status : Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Glatiramer acetate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study to Evaluate the Safety of Copaxone(R) and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone(R)
Actual Study Start Date : May 2, 1994
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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®



Primary Outcome Measures :
  1. EDSS for efficacy every 6 months and adverse events for safety every 3 months. [ Time Frame: 26 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203021


Locations
United States, California
Teva Investigational Site 009
Los Angeles, California, United States, 90033
Teva Investigational Site 004
Los Angeles, California, United States, 90095-7077
United States, Connecticut
Teva Investigational Site 008
New Haven, Connecticut, United States, 06520-8018
United States, Maryland
Teva Investigational Site 005
Baltimore, Maryland, United States, 21201
United States, Michigan
Teva Investigational Site 003
Detroit, Michigan, United States, 48201
United States, New Mexico
Teva Investigational Site 002
Albuquerque, New Mexico, United States, 87131
United States, New York
Teva Investigational Site 007
Rochester, New York, United States, 14642
United States, Pennsylvania
Teva Investigational Site 001
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Teva Investigational Site 010
Houston, Texas, United States, 77030
United States, Utah
Teva Investigational Site 006
Salt Lake City, Utah, United States, 84148
United States, Wisconsin
Teva Investigational Site 011
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Cory Ford, MD University of New Mexico

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT00203021     History of Changes
Other Study ID Numbers: GA-9004
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Glatiramer Acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents