Trial Outcomes & Findings for A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study (NCT NCT01036165)

Last Updated: 2013-08-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

103 participants

Primary outcome timeframe

at 12 Weeks

Results posted on

2013-08-08

Participant Flow

103 subjects were recruited from 15 US clinics in the US during the trial period February 2010 to August 2010

Subjects who signed informed consent and satisfied the eligibility critera at screening returned to the clinic on study day 1 to begin treatment with the Rebismart autoinjector. All subjects participating in the trial received Rebif 44 mcg sc tiw using the Rebismart autoinjector for 12 weeks.

Participant milestones

Participant milestones
Measure	Subject Disposition Intent-to-Treat Analysis
Overall Study STARTED	103
Overall Study COMPLETED	88
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Subject Disposition Intent-to-Treat Analysis
Overall Study Adverse Event	6
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	3
Overall Study Device Related Issues	3
Overall Study Problems finding proper area to inject	1

Baseline Characteristics

A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subject Disposition n=103 Participants Intent-to-Treat Analysis
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	103 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	46.4 years STANDARD_DEVIATION 9.35 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	103 participants n=5 Participants

PRIMARY outcome

Timeframe: at 12 Weeks

Outcome measures

Outcome measures
Measure	Subject Disposition n=103 Participants Intent-to-Treat Analysis
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.	0.78 Proportion of subjects Interval 0.7 to 0.86

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subject Disposition n=103 Participants Intent-to-Treat Analysis
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. Device makes injections simple	81.8 Percentage of subjects Interval 73.8 to 89.9
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. Allows easy access to skin injection sites	79.5 Percentage of subjects Interval 71.1 to 88.0
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. Helps me self-administer Injections	84.1 Percentage of subjects Interval 76.4 to 91.7
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. Step by step Instructions are a key benefit	93.2 Percentage of subjects Interval 87.9 to 98.4
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. Ease of using injection device	90.9 Percentage of subjects Interval 84.9 to 96.9
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. Ease of loading cartridge	97.7 Percentage of subjects Interval 94.6 to 100.0
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. Ease of inserting the needle	84.1 Percentage of subjects Interval 76.4 to 91.7
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. Ease of pushing the button	96.6 Percentage of subjects Interval 92.8 to 100.0
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. Ease of holding device during injection	84.1 Percentage of subjects Interval 76.4 to 91.7
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. Ease of removing the needle from device	76.1 Percentage of subjects Interval 67.2 to 85.0
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. Able to often or always administer full injection	98.9 Percentage of subjects Interval 96.6 to 100.0
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. Rate the convenience of the device	87.5 Percentage of subjects Interval 80.6 to 94.4

Adverse Events

Subject Disposition

Serious events: 1 serious events

Other events: 92 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Subject Disposition n=103 participants at risk；n=99 participants at risk Intent-to-Treat Analysis
Infections and infestations Appendicitis	1.0% 1/99 • Number of events 1
Renal and urinary disorders Nephrolithiasis	1.0% 1/99 • Number of events 1

Other adverse events

Other adverse events
Measure	Subject Disposition n=103 participants at risk；n=99 participants at risk Intent-to-Treat Analysis
General disorders Influenza like illness	10.7% 11/103 • Number of events 11
General disorders Injection site erythema	34.0% 35/103 • Number of events 35
General disorders Injection site haematoma	11.7% 12/103 • Number of events 12
General disorders Injection Site Pain	50.5% 52/103 • Number of events 52
General disorders Urinary Tract Infection	7.8% 8/103 • Number of events 8
Nervous system disorders Headache	5.8% 6/103 • Number of events 6
Nervous system disorders Multiple Sclerosis relapse	8.7% 9/103 • Number of events 9
General disorders Injection site haemorrhage	6.8% 7/103 • Number of events 7

Additional Information

Fernando Dangond, MD

EMD Serono, Inc.

Phone: 781-681-2348

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Neither Institution nor any Principal Investigators shall publish or present any results from such Study to any third parties until: (i) EMD Serono publishes the results from all sites participating in such Study; (ii) Institution receives notification from EMD Serono that publication of the multi-site results is no longer planned; or (iii) twenty-four (24) months following the completion of the multi-site study at all sites, whichever occurs first.
Publication restrictions are in place

Restriction type: OTHER