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

NCT00203021 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: GA-900401-9004
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 11

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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Glatiramer Acetate: Delayed Start

EXPERIMENTAL

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: Early Start

EXPERIMENTAL

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

Interventions

Glatiramer acetate DRUG

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

Also known as: Copaxone®

Glatiramer Acetate: Delayed Start; Glatiramer Acetate: Early Start

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (11)

Teva Investigational Site 009

Los Angeles, California, 90033, United States

Location

Teva Investigational Site 004

Los Angeles, California, 90095-7077, United States

Location

Teva Investigational Site 008

New Haven, Connecticut, 06520-8018, United States

Location

Teva Investigational Site 005

Baltimore, Maryland, 21201, United States

Location

Teva Investigational Site 003

Detroit, Michigan, 48201, United States

Location

Teva Investigational Site 002

Albuquerque, New Mexico, 87131, United States

Location

Teva Investigational Site 007

Rochester, New York, 14642, United States

Location

Teva Investigational Site 001

Philadelphia, Pennsylvania, 19104, United States

Location

Teva Investigational Site 010

Houston, Texas, 77030, United States

Location

Teva Investigational Site 006

Salt Lake City, Utah, 84148, United States

Location

Teva Investigational Site 011

Madison, Wisconsin, 53719, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Cory Ford, MD

  University of New Mexico

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: March 26, 1994
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: February 18, 2020
• Results First Posted: July 18, 2019

Record last verified: 2020-02

Locations

US (11)