The Multicenter, Open-label, Single-use Autoinjector Convenience Study
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ClinicalTrials.gov Identifier: NCT00958009 |
Recruitment Status :
Completed
First Posted : August 13, 2009
Results First Posted : December 30, 2010
Last Update Posted : August 7, 2013
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Sponsor:
EMD Serono
Information provided by:
EMD Serono
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Tracking Information | ||||
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First Submitted Date ICMJE | August 12, 2009 | |||
First Posted Date ICMJE | August 13, 2009 | |||
Results First Submitted Date ICMJE | December 1, 2010 | |||
Results First Posted Date ICMJE | December 30, 2010 | |||
Last Update Posted Date | August 7, 2013 | |||
Study Start Date ICMJE | October 2009 | |||
Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 ] 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.
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Original Primary Outcome Measures ICMJE |
Proportion of 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 ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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 ] 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.
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Original Secondary Outcome Measures ICMJE |
Multiple secondary endpoints will be assessed, based on questions from the User Trial Questionnaire at Study Day 1, Week 6 and Week 12/Exit, related to the single-use autoinjector device use-related outcomes. [ Time Frame: at 12 weeks ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The Multicenter, Open-label, Single-use Autoinjector Convenience Study | |||
Official Title ICMJE | 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) | |||
Brief 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). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) |
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Condition ICMJE | Multiple Sclerosis | |||
Intervention ICMJE | Device: Rebidose®
The device is a ready to use single use auto injector containing Rebif® 44 mcg in a 0.5 mL prefilled syringe for sc injection
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
109 | |||
Original Estimated Enrollment ICMJE |
100 | |||
Actual Study Completion Date ICMJE | June 2010 | |||
Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00958009 | |||
Other Study ID Numbers ICMJE | 29651 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Fernando Dangond, , Senior Director, Medical Affairs Neurology, EMD Serono, Inc. | |||
Study Sponsor ICMJE | EMD Serono | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | EMD Serono | |||
Verification Date | August 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |