CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 208 enrolled
Drug / intervention
Glatiramer acetatedrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Prior randomization in Copaxone double-blind study 01-9001 and/or extension study 01-9001E
  • ✓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 Kurtzke EDSS score 0 to 5.0 inclusive
Key exclusion· 4
  • ✕Pregnancy or lactation
  • ✕Medical or psychiatric conditions affecting ability to give informed consent or complete the study
  • ✕Prior or concurrent use of interferon or experimental MS therapies
  • ✕Prior immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00203021
NCT00203021Phase 4Completed
CompareCT.gov

Open Label Study to Evaluate the Safety of Copaxone® and to Monitor the Neurologic Course of Disease in Multiple Sclerosis Patients Treated With Copaxone

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Sep 20, 2005·Updated Feb 18, 2020

In Brief

A Phase 4 clinical trial evaluating Glatiramer acetate for Relapsing-Remitting Multiple Sclerosis. Completed, enrolled 208 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing-Remitting Multiple Sclerosis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
1994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartMar 26, 1994
Primary CompletionFeb 28, 2018
TodayJul 2, 2026
Enrollment to primary: 23.9 yearsPosted 20.8 years ago

Interventions

Glatiramer acetatedrug

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