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NCT00203021 · ClinicalTrials.gov registry record · Phase 4
Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness
A Phase 4 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 4
- Development phase
- 208
- Enrollment target
NCT00203021: Completed Phase 4 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT00203021 is a Phase 4 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 208 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00203021, a Phase 4 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 208 participants
- Enrollment target
Study 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.
Primary Outcome
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 t
Interventions
- DRUG Glatiramer acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 1994-03-26 |
| Est. Completion | 2018-02-28 |
| Phase | Phase 4 |
What the finished NCT00203021 record still lists
NCT00203021 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Glatiramer acetate is the first listed.
NCT00203021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00203021 about?
NCT00203021 is a clinical study titled "Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness". 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 Multipl...
What is the current status of trial NCT00203021?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 208 participants. The study started on 1994-03-26. Estimated completion is 2018-02-28.
What interventions are being tested in trial NCT00203021?
The interventions under investigation include: Glatiramer acetate (DRUG).
Who is sponsoring clinical trial NCT00203021?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00203021's enrollment target sits among peer trials
208 399th of 2000 higher than 1,600 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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