A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study (Performs)
This study has been completed.
Information provided by:
First received: December 18, 2009
Last updated: November 30, 2010
Last verified: November 2010
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Twelve-week, Phase IIIb, Open-label, Single-arm, Multicenter Trial to Evaluate Ease of Use of an Electronic Autoinjector (RebiSmart™) for Self-injection in Subjects With Relapsing Multiple Sclerosis (RMS) Treated With Rebif® 44mcg Subcutaneously (sc) Three Times a Week (Tiw)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by EMD Serono:
Primary Outcome Measures:
- The Primary Endpoint is the Proportion of RMS Subjects Rating the RebiSmart™ Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire. [ Time Frame: at 12 Weeks ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]The User Trial Questionnaire B was administered at Week 6 and Week 12 to assess the ease of use, functional reliability, overall satisfaction, satisfaction with device attributes, convenience, safety and portability of the Rebismart. Means and confidence intervals refer to the proportion of subjects responding positively, based on the number of non-missing values for each question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.
|Study Start Date:||January 2010|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
The RebiSmart™ autoinjector contains Rebif® 132 mcg multidose cartridges for sc injection.
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