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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203021
• Other study ID #: GA-9004
• Secondary ID: 01-9004
• Status: Completed
• Phase: Phase 4
• Start date: March 26, 1994
• Est. completion date: February 28, 2018

Study information

• Verified date: February 2020
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Glatiramer acetate
Glatiramer acetate will be administered as per the dose and schedule specified in the respective arms.

Locations

Country	Name	City	State
United States	Teva Investigational Site 002	Albuquerque	New Mexico
United States	Teva Investigational Site 005	Baltimore	Maryland
United States	Teva Investigational Site 003	Detroit	Michigan
United States	Teva Investigational Site 010	Houston	Texas
United States	Teva Investigational Site 004	Los Angeles	California
United States	Teva Investigational Site 009	Los Angeles	California
United States	Teva Investigational Site 011	Madison	Wisconsin
United States	Teva Investigational Site 008	New Haven	Connecticut
United States	Teva Investigational Site 001	Philadelphia	Pennsylvania
United States	Teva Investigational Site 007	Rochester	New York
United States	Teva Investigational Site 006	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products, R&D Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to Month 288
Primary	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).	Baseline, Month 288