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Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness

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ClinicalTrials.gov Identifier: NCT00203021
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
This open-label extension study will evaluate the long-term safety of glatiramer acetate and its effect on the neurologic course of participants with relapsing-remitting multiple sclerosis (RRMS). Participants have scheduled visits every 3 months to assess glatiramer acetate safety and their Multiple Sclerosis (MS) status.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : March 26, 1994
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glatiramer Acetate: Delayed Start
Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 milligrams (mg) subcutaneous (SC) injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg three times weekly (TIW). The treatment continued for up to 288 months.
Drug: Glatiramer acetate
Glatiramer acetate will be administered as per the dose and schedule specified in the respective arms.
Other Name: Copaxone®

Experimental: Glatiramer Acetate: Early Start
Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.
Drug: Glatiramer acetate
Glatiramer acetate will be administered as per the dose and schedule specified in the respective arms.
Other Name: Copaxone®




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Month 288 ]
    An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Any AEs included both serious and non-serious AEs. A summary of other non-serious AEs and all serious AEs, regardless of causality, is located in Reported AE section.

  2. Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288 [ Time Frame: Baseline, Month 288 ]
    The EDSS uses an ordinal scale to assess neurologic impairment in Multiple Sclerosis based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral) and an ambulation score were combined to determine the total EDSS score, ranging from 0 (normal) to 10 (death due to Multiple Sclerosis).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have participated (been randomized) in the Copaxone double-blind placebo-controlled study 01-9001 and/or the double-placebo-controlled extension study 01-9001E.
  • Participants could be male or female. Women of childbearing potential must have practiced an acceptable method of birth control.
  • Participants must have completed the scheduled termination visit for Amendment 12 (Month 264).
  • Participants must have signed an approved informed consent form (ICF) prior to continuing in the study extension or at the first visit in the extension (Month 264 which corresponds to the termination visit of Amendment 12).
  • Participants must have been psychologically and physically stable to participate in the trial as judged by the investigator.
  • All participants enrolled in this extension study were required to have the following study-specific baseline characteristics prior to entry to Study 01-9001: a diagnosis of RRMS as defined by Poser et al 1983, at least 2 clearly identified relapses and remissions in the 2-year period prior to study entry, ambulatory with a Kurtzke EDSS score of 0 to 5.0 inclusive, and a stable neurologic state for at least 30 days prior to study entry.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Medical or psychiatric conditions that affect the participant'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 approved MS therapies including interferons, experimental MS therapies, or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine).

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
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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
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Study Director: Cory Ford, MD University of New Mexico
  Study Documents (Full-Text)

Documents provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):

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Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT00203021     History of Changes
Other Study ID Numbers: GA-9004
01-9004 ( Other Identifier: Teva )
First Posted: September 20, 2005    Key Record Dates
Results First Posted: July 18, 2019
Last Update Posted: July 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glatiramer Acetate
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents