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

Primary Purpose

Relapsing-Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glatiramer acetate
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Teva Investigational Site 009
  • Teva Investigational Site 004
  • Teva Investigational Site 008
  • Teva Investigational Site 005
  • Teva Investigational Site 003
  • Teva Investigational Site 002
  • Teva Investigational Site 007
  • Teva Investigational Site 001
  • Teva Investigational Site 010
  • Teva Investigational Site 006
  • Teva Investigational Site 011

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Glatiramer Acetate: Delayed Start

Glatiramer Acetate: Early Start

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs)
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.
Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at 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).

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
February 14, 2020
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00203021
Brief Title
Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 26, 1994 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glatiramer Acetate: Delayed Start
Arm Type
Experimental
Arm Description
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.
Arm Title
Glatiramer Acetate: Early Start
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Glatiramer acetate
Other Intervention Name(s)
Copaxone®
Intervention Description
Glatiramer acetate will be administered as per the dose and schedule specified in the respective arms.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Baseline up to Month 288
Title
Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288
Description
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).
Time Frame
Baseline, Month 288

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cory Ford, MD
Organizational Affiliation
University of New Mexico
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 009
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Teva Investigational Site 004
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7077
Country
United States
Facility Name
Teva Investigational Site 008
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8018
Country
United States
Facility Name
Teva Investigational Site 005
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Teva Investigational Site 003
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Teva Investigational Site 002
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Teva Investigational Site 007
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Teva Investigational Site 001
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Teva Investigational Site 010
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Teva Investigational Site 006
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
Teva Investigational Site 011
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

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

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