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NCT01874145 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability of Glatiramer Acetate
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 209
- Enrollment target
NCT01874145: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01874145 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 209 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01874145, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 209 participants
- Enrollment target
Study Summary
This is an open-label, randomized, multi-center, parallel-arm study to assess the safety and tolerability of a daily dose of Glatiramer Acetate (GA) 40 mg/mL three times a week (TIW) administered subcutaneously (SC) as compared to GA 20 mg/mL every day (QD) administered SC.
Primary Outcome
Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years. For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient. Parameter statist
Interventions
- DRUG GA 20 mg/mL
- DRUG GA 40 mg/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 209 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT01874145 record still lists
NCT01874145 is an interventional study that assigns participants to a tested intervention. The registered 209 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which GA 20 mg/mL is the first listed.
NCT01874145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01874145 about?
NCT01874145 is a clinical study titled "Safety and Tolerability of Glatiramer Acetate". This is an open-label, randomized, multi-center, parallel-arm study to assess the safety and tolerability of a daily dose of Glatiramer Acetate (GA) 40 mg/mL three times a week (TIW) administered subcutaneously (SC) as compared to GA 20 mg/mL every day (QD) administered SC.
What is the current status of trial NCT01874145?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 209 participants. The study started on 2013-06. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01874145?
The interventions under investigation include: GA 20 mg/mL (DRUG), GA 40 mg/mL (DRUG).
Who is sponsoring clinical trial NCT01874145?
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 NCT01874145's enrollment target sits among peer trials
209 1345th of 2000 higher than 656 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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