Trial Outcomes & Findings for The Multicenter, Open-label, Single-use Autoinjector Convenience Study (NCT NCT00958009)

Last Updated: 2013-08-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

109 participants

Primary outcome timeframe

at 12 weeks

Results posted on

2013-08-07

Participant Flow

109 subjects were recruited from 12 US clinics in the US during the trial period Oct 2009 to April 2010.

Subjects who signed informed consent and satisfied the eligibility critera at screening returned to the clinic on study day 1 to begin treatment. All subjects participating in the trial received Rebif 44 mcg subcutaneious (sc, three times per week (tiw) using the single-use autoinjector (SA).

Participant milestones

Participant milestones
Measure	RMS Subject Disposition Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
Overall Study STARTED	109
Overall Study COMPLETED	107
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	RMS Subject Disposition Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
Overall Study Adverse Event	1
Overall Study Subject found device difficult to use	1

Baseline Characteristics

The Multicenter, Open-label, Single-use Autoinjector Convenience Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RMS Subject Disposition n=109 Participants Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	109 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	46.0 years STANDARD_DEVIATION 9.32 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	109 participants n=5 Participants

PRIMARY outcome

Timeframe: at 12 weeks

Population: Subjects in the all enrolled analysis set who received at least one dose of investigational medicinal product (IMP) were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data.

Outcome measures

Outcome measures
Measure	RMS Subject Disposition n=109 Participants Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
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	0.86 Proportion of subjects Interval 0.8 to 0.93

SECONDARY outcome

Timeframe: at 12 weeks

Population: Subjects in the all enrolled analysis set who received at least one dose of IMP were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data.

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.

Outcome measures

Outcome measures
Measure	RMS Subject Disposition n=109 Participants Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Device makes injections simple	0.83 Proportion of subjects Interval 0.77 to 0.9
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Allows easy access to skin injection sites	0.78 Proportion of subjects Interval 0.7 to 0.86
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Helps me self-administer injections	0.83 Proportion of subjects Interval 0.75 to 0.9
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Ease of pushing device against skin	0.76 Proportion of subjects Interval 0.68 to 0.84
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Ease of holding device during injection	0.77 Proportion of subjects Interval 0.69 to 0.85
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Able to often or always administer full injection	0.96 Proportion of subjects Interval 0.93 to 1.0
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Satisfaction with size of device	0.61 Proportion of subjects Interval 0.51 to 0.7
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Satisfaction with ease of removing cap from device	0.87 Proportion of subjects Interval 0.81 to 0.93
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Satisfaction with ease of activating button	0.78 Proportion of subjects Interval 0.7 to 0.86
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Satisfaction with time to inject medicine	0.83 Proportion of subjects Interval 0.75 to 0.9
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Satisfaction with ability to see post injection	0.81 Proportion of subjects Interval 0.73 to 0.88
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Rate convenience of device	0.74 Proportion of subjects Interval 0.66 to 0.83
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. Rate how reliable injection device was	0.79 Proportion of subjects Interval 0.71 to 0.87

Adverse Events

RMS Subject Disposition

Serious events: 4 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RMS Subject Disposition n=109 participants at risk Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
General disorders Chest Pain	0.92% 1/109 • Number of events 1
Cardiac disorders Angina pectoris	0.92% 1/109 • Number of events 1
Gastrointestinal disorders Pancreatitis acute	0.92% 1/109 • Number of events 1
Nervous system disorders Convulsion	0.92% 1/109 • Number of events 1
Vascular disorders Hypertension	0.92% 1/109 • Number of events 1

Other adverse events

Other adverse events
Measure	RMS Subject Disposition n=109 participants at risk Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
General disorders Influenza like illness	23.9% 26/109 • Number of events 26
General disorders Injection site erythema	35.8% 39/109 • Number of events 39
General disorders Injection site haematoma	11.9% 13/109 • Number of events 13
General disorders Injection site pain	24.8% 27/109 • Number of events 27
General disorders Injection site swelling	7.3% 8/109 • Number of events 8
Infections and infestations Upper respiratory tract infection	5.5% 6/109 • Number of events 6
Nervous system disorders Headache	6.4% 7/109 • 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