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NCT00958009 · ClinicalTrials.gov registry record · Phase 3

The Multicenter, Open-label, Single-use Autoinjector Convenience Study

A Phase 3 study, sponsored by EMD Serono.

Completed
Registry status
Phase 3
Development phase
109
Enrollment target

NCT00958009: Completed Phase 3 study, sponsored by EMD Serono.

NCT00958009 is a Phase 3 study that has completed, run by EMD Serono. The registered enrollment target is 109 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00958009, a Phase 3 study, has completed, sponsored by EMD Serono.

COMPLETED
Registry status
Phase 3
Development phase
109 participants
Enrollment target

Study Summary

The purpose of this trial is to test the Single-Use Autoinjector for a) ease of use; b) multiple domains related to subject's acceptability and satisfaction, and c) reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with relapsing multiple sclerosis (RMS).

Primary Outcome

Data from the User Trial Questionnaire, Question 14 (Overall, how do you rate your experience with using the injection device?) Mean and confidence interval refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.

Interventions

  • DEVICE Rebidose®

Trial Details

FieldValue
Enrollment Target 109 participants
Start Date 2009-10
Est. Completion 2010-06
Phase Phase 3
EMD Serono

71 total trials

What the finished NCT00958009 record still lists

NCT00958009 is an interventional study that assigns participants to a tested intervention. The registered 109 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 (86% lower).

The record links to 0 conditions, and to 1 intervention - of which Rebidose® is the first listed.

NCT00958009 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00958009 about?

NCT00958009 is a clinical study titled "The Multicenter, Open-label, Single-use Autoinjector Convenience Study". The purpose of this trial is to test the Single-Use Autoinjector for a) ease of use; b) multiple domains related to subject's acceptability and satisfaction, and c) reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with relapsing multiple sclerosis (RMS).

What is the current status of trial NCT00958009?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 109 participants. The study started on 2009-10. Estimated completion is 2010-06.

What interventions are being tested in trial NCT00958009?

The interventions under investigation include: Rebidose® (DEVICE).

Who is sponsoring clinical trial NCT00958009?

This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00958009's enrollment target sits among peer trials

109 1664th of 2000 higher than 337 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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Source: ClinicalTrials.gov NCT00958009, the US trial registry maintained by the National Library of Medicine. NCT00958009 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.