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).
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Twelve-week, Phase IIIb, Open-label, Single-arm, Multicenter Trial to Evaluate Ease of Use of a Ready-to-use, Single-use Autoinjector (SA) for Self-injection in Subjects With Relapsing Multiple Sclerosis (RMS) Treated With Rebif® 44mcg Subcutaneously (sc), Three Times a Week (Tiw)|
- Proportion of Relapsing Multiple Sclerosis (RMS) Subjects Rating the Single-use 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, 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.
- Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]The User Trial Questionnaire was used to assess the ease of use, functional reliability, overall satisfaction with device attributes, convenience, safety and portability of the device. Mean and confidence intervals refer to proportion of subjects responding positively to question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.
|Study Start Date:||October 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958009
|United States, Massachusetts|
|EMD Serono, Inc.|
|Rockland, Massachusetts, United States, 02370|
|Study Director:||Fernando Dangond, MD||EMD Serono|