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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT00203021
Date of registration: 12/09/2005
Prospective Registration: No
Primary sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Public title: Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness
Scientific 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
Date of first enrolment: March 26, 1994
Target sample size: 208
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
United States
Name:     Cory Ford, MD
Affiliation:  University of New Mexico
Key inclusion & exclusion 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

- 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).

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Relapsing-Remitting Multiple Sclerosis
Drug: Glatiramer acetate
Primary Outcome(s)
Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288 [Time Frame: Baseline, Month 288]
Number of Participants With Adverse Events (AEs) [Time Frame: Baseline up to Month 288]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available: Yes
Date Posted: 18/07/2019
Date Completed:
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