Phase 4
Completed N=208
Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness
Source: ClinicalTrials.gov NCT00203021 ↗Enrolled (actual)
208
Serious AEs
39.4%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 107; 100; 44; 38 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
107; 100; 44; 38 | — |
| PRIMARY Change From Baseline in Kurtzke Expanded Disability Status Scale (EDSS) Score at Month 288 |
2.34; 2.23; 1.64; 1.06 | — |
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).
Data sourced from ClinicalTrials.gov (NCT00203021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.