A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study (Performs)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01036165|
Recruitment Status : Completed
First Posted : December 21, 2009
Results First Posted : December 22, 2010
Last Update Posted : August 8, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Device: RebiSmart™||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
- Device: RebiSmart™
The RebiSmart™ autoinjector contains Rebif® 132 mcg multidose cartridges for sc injection.
- 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 ]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.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036165
|United States, Massachusetts|
|EMD Serono, Inc.|
|Rockland, Massachusetts, United States, 02370|
|Study Director:||Fernando Dangond, MD||EMD Serono|