Clinical trial NCT00203021: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing-Remitting Multiple Sclerosis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Month 288
measure: Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288
timeFrame: Baseline, Month 288
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Teva Investigational Site 009
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 004
state: California
city: New Haven
country: United States
facility: Teva Investigational Site 008
state: Connecticut
city: Baltimore
country: United States
facility: Teva Investigational Site 005
state: Maryland
city: Detroit
country: United States
facility: Teva Investigational Site 003
state: Michigan
city: Albuquerque
country: United States
facility: Teva Investigational Site 002
state: New Mexico
city: Rochester
country: United States
facility: Teva Investigational Site 007
state: New York
city: Philadelphia
country: United States
facility: Teva Investigational Site 001
state: Pennsylvania
city: Houston
country: United States
facility: Teva Investigational Site 010
state: Texas
city: Salt Lake City
country: United States
facility: Teva Investigational Site 006
state: Utah
city: Madison
country: United States
facility: Teva Investigational Site 011
state: Wisconsin
Study officials:
affiliation: University of New Mexico
name: Cory Ford, MD
role: STUDY_DIRECTOR
References: