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NCT01618955 · ClinicalTrials.gov registry record · Phase 2
Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device
A Phase 2 study, sponsored by Antares Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
NCT01618955: Completed Phase 2 study, sponsored by Antares Pharma.
NCT01618955 is a Phase 2 study that has completed, run by Antares Pharma. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01618955, a Phase 2 study, has completed, sponsored by Antares Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.
Primary Outcome
A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device. The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient's performance of essential self-injection steps, including the following: 1. SC self-injection was administered by the patient 2. SC self-injection w
Interventions
- DEVICE VIBEX MTX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2012-05 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
What the finished NCT01618955 record still lists
NCT01618955 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 1 intervention - of which VIBEX MTX is the first listed.
NCT01618955 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01618955 about?
NCT01618955 is a clinical study titled "Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device". The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.
What is the current status of trial NCT01618955?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2012-05. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01618955?
The interventions under investigation include: VIBEX MTX (DEVICE).
Who is sponsoring clinical trial NCT01618955?
This trial is sponsored by Antares Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01618955's enrollment target sits among peer trials
101 672nd of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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