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NCT01036165 · ClinicalTrials.gov registry record · Phase 3
A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study
A Phase 3 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 3
- Development phase
- 103
- Enrollment target
NCT01036165: Completed Phase 3 study, sponsored by EMD Serono.
NCT01036165 is a Phase 3 study that has completed, run by EMD Serono. The registered enrollment target is 103 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01036165, a Phase 3 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 103 participants
- Enrollment target
Study Summary
The purpose of this study is to test the RebiSmart™ for * ease of use * multiple domains related to subject's acceptability and satisfaction * reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with RMS.
Primary Outcome
Data from the User Trial Questionnaire-B, Question 13 (Overall, how do you rate your experience with using the injection device). Mean and confidence intervals refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.
Interventions
- DEVICE RebiSmart™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2010-01 |
| Est. Completion | 2010-08 |
| Phase | Phase 3 |
What the finished NCT01036165 record still lists
NCT01036165 is an interventional study that assigns participants to a tested intervention. The registered 103 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 (87% lower).
The record links to 0 conditions, and to 1 intervention - of which RebiSmart™ is the first listed.
NCT01036165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01036165 about?
NCT01036165 is a clinical study titled "A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study". The purpose of this study is to test the RebiSmart™ for * ease of use * multiple domains related to subject's acceptability and satisfaction * reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with RMS.
What is the current status of trial NCT01036165?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 103 participants. The study started on 2010-01. Estimated completion is 2010-08.
What interventions are being tested in trial NCT01036165?
The interventions under investigation include: RebiSmart™ (DEVICE).
Who is sponsoring clinical trial NCT01036165?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01036165's enrollment target sits among peer trials
103 1674th of 2000 higher than 325 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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