Trial Outcomes & Findings for Rebif® Rebidose® Versus Rebiject II® Ease-of-Use (NCT NCT02019550)
NCT ID: NCT02019550
Last Updated: 2017-03-07
Results Overview
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device sequence.
COMPLETED
PHASE4
97 participants
Week 4
2017-03-07
Participant Flow
The study was conducted at 32 sites in the United States.
Overall, 103 subjects were screened, for inclusion in this trial. Of which, 97 subjects were randomized into the study.
Participant milestones
| Measure |
First Rebif Rebidose, Then Rebiject II
Subjects self-injected Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Treatment Period 1 (4 Weeks)
STARTED
|
46
|
51
|
|
Treatment Period 1 (4 Weeks)
COMPLETED
|
46
|
50
|
|
Treatment Period 1 (4 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Treatment Period 2 (4 Weeks)
STARTED
|
46
|
50
|
|
Treatment Period 2 (4 Weeks)
COMPLETED
|
46
|
50
|
|
Treatment Period 2 (4 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
First Rebif Rebidose, Then Rebiject II
Subjects self-injected Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Treatment Period 1 (4 Weeks)
Adverse Event
|
0
|
1
|
Baseline Characteristics
Rebif® Rebidose® Versus Rebiject II® Ease-of-Use
Baseline characteristics by cohort
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=51 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 9.78 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 11.20 • n=7 Participants
|
48.4 years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
|
Gender
Female
|
40 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Gender
Male
|
6 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 4
Easy
|
34.8 percentage of subjects
|
50.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 4
Very easy
|
39.1 percentage of subjects
|
30.0 percentage of subjects
|
PRIMARY outcome
Timeframe: Week 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 8
Easy
|
45.7 percentage of subjects
|
24.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 8
Very easy
|
30.4 percentage of subjects
|
40.0 percentage of subjects
|
PRIMARY outcome
Timeframe: Baseline up to Week 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device used.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=96 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=96 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) up to Week 8
Easy
|
29.2 percentage of subjects
|
47.9 percentage of subjects
|
|
Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) up to Week 8
Very easy
|
39.6 percentage of subjects
|
30.2 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" = subjects evaluable for this outcome, "Number Analyzed"=subjects evaluable at the specified time point.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with using the device while traveling (defined as being away from home overnight). Subjects assessed if they were satisfied with their ability to use the device while traveling overnight as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree". Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=17 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=21 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)
Week 4: Strongly disagree
|
0 subjects
|
0 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)
Week 4: Disagree
|
0 subjects
|
0 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)
Week 4: Neither agree nor disagree
|
2 subjects
|
1 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)
Week 4: Agree
|
5 subjects
|
7 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)
Week 4: Strongly agree
|
10 subjects
|
10 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)
Week 8: Strongly disagree
|
1 subjects
|
0 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)
Week 8: Disagree
|
0 subjects
|
0 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)
Week 8: Neither agree nor disagree
|
1 subjects
|
3 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)
Week 8: Agree
|
8 subjects
|
9 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)
Week 8: Strongly agree
|
6 subjects
|
9 subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies subjects evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with respect to the amount of time it took to complete injection with the device. Subjects assessed if they were satisfied as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree". Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)
Week 4: Strongly disagree
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)
Week 4: Disagree
|
2.2 percentage of subjects
|
8.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)
Week 4: Neither agree nor disagree
|
10.9 percentage of subjects
|
8.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)
Week 4: Agree
|
39.1 percentage of subjects
|
50.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)
Week 4: Strongly agree
|
47.8 percentage of subjects
|
34.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)
Week 8: Strongly disagree
|
2.2 percentage of subjects
|
4.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)
Week 8: Disagree
|
6.5 percentage of subjects
|
2.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)
Week 8: Neither agree nor disagree
|
0.0 percentage of subjects
|
4.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)
Week 8: Agree
|
50.0 percentage of subjects
|
44.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)
Week 8: Strongly agree
|
41.3 percentage of subjects
|
46.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies subjects evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with respect to number of steps it took to complete an injection with the device. Subjects assessed if they were satisfied as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree". Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)
Week 4: Strongly disagree
|
0.0 percentage of subjects
|
2.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)
Week 4: Disagree
|
0.0 percentage of subjects
|
10.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)
Week 4: Neither agree nor disagree
|
0.0 percentage of subjects
|
20.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)
Week 4: Agree
|
52.2 percentage of subjects
|
42.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)
Week 4: Strongly agree
|
47.8 percentage of subjects
|
26.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)
Week 8: Strongly disagree
|
2.2 percentage of subjects
|
4.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)
Week 8: Disagree
|
6.5 percentage of subjects
|
4.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)
Week 8: Neither agree nor disagree
|
8.7 percentage of subjects
|
4.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)
Week 8: Agree
|
45.7 percentage of subjects
|
38.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)
Week 8: Strongly agree
|
37.0 percentage of subjects
|
50.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies subjects evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with holding the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)
Week 4: very difficult
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)
Week 4: difficult
|
4.3 percentage of subjects
|
6.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)
Week 4: neither easy nor difficult
|
21.7 percentage of subjects
|
18.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)
Week 4: easy
|
43.5 percentage of subjects
|
48.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)
Week 4: very easy
|
30.4 percentage of subjects
|
28.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)
Week 8: very difficult
|
0.0 percentage of subjects
|
4.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)
Week 8: difficult
|
6.5 percentage of subjects
|
12.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)
Week 8: neither easy nor difficult
|
13.0 percentage of subjects
|
20.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)
Week 8: easy
|
43.5 percentage of subjects
|
28.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)
Week 8: very easy
|
37.0 percentage of subjects
|
36.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" = subjects evaluable for this outcome, "Number Analyzed"=subjects evaluable at the specified time point.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with using the device while away from home. Subjects assessed if they were satisfied with their ability to use the device while away from home as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree". Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=17 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=18 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)
Week 4: Strongly agree
|
4 subjects
|
9 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)
Week 4: Strongly disagree
|
1 subjects
|
0 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)
Week 4: Disagree
|
0 subjects
|
0 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)
Week 4: Neither agree nor disagree
|
0 subjects
|
1 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)
Week 4: Agree
|
6 subjects
|
8 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)
Week 8: Strongly disagree
|
0 subjects
|
0 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)
Week 8: Disagree
|
0 subjects
|
0 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)
Week 8: Neither agree nor disagree
|
0 subjects
|
1 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)
Week 8: Agree
|
6 subjects
|
7 subjects
|
|
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)
Week 8: Strongly agree
|
11 subjects
|
8 subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies subjects evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of convenience of using the device as "Extremely inconvenient", "Somewhat inconvenient", "Neutral/no opinion", "Somewhat convenient", or "Extremely convenient". Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)
Week 4: Extremely inconvenient
|
0.0 percentage of subjects
|
2.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)
Week 4: Somewhat inconvenient
|
8.7 percentage of subjects
|
18.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)
Week 4: Neutral/no opinion
|
4.3 percentage of subjects
|
10.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)
Week 4: Somewhat convenient
|
26.1 percentage of subjects
|
44.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)
Week 4: Extremely convenient
|
60.9 percentage of subjects
|
26.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)
Week 8: Extremely inconvenient
|
2.2 percentage of subjects
|
4.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)
Week 8: Somewhat inconvenient
|
15.2 percentage of subjects
|
8.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)
Week 8: Neutral/no opinion
|
8.7 percentage of subjects
|
8.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)
Week 8: Somewhat convenient
|
39.1 percentage of subjects
|
34.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)
Week 8: Extremely convenient
|
34.8 percentage of subjects
|
46.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies subjects evaluable for this outcome. Here results are presented by device sequence.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess how convenient it was to store the injection device. Subjects responded as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree" that the device was convenient to store.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)
Week 4: Disagree
|
19.6 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)
Week 4: Strongly disagree
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)
Week 4: Neither agree nor disagree
|
15.2 percentage of subjects
|
8.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)
Week 4: Agree
|
34.8 percentage of subjects
|
58.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)
Week 4: Strongly agree
|
30.4 percentage of subjects
|
34.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)
Week 8: Strongly disagree
|
0.0 percentage of subjects
|
2.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)
Week 8: Disagree
|
2.2 percentage of subjects
|
24.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)
Week 8: Neither agree nor disagree
|
4.3 percentage of subjects
|
12.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)
Week 8: Agree
|
54.3 percentage of subjects
|
40.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)
Week 8: Strongly agree
|
39.1 percentage of subjects
|
22.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies subjects evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess whether the device features help minimize safety hazards. Subjects responded as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree". Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)
Week 4: Strongly agree
|
34.8 percentage of subjects
|
20.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)
Week 4: Strongly disagree
|
0.0 percentage of subjects
|
4.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)
Week 4: Disagree
|
0.0 percentage of subjects
|
6.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)
Week 4: Neither agree nor disagree
|
30.4 percentage of subjects
|
22.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)
Week 4: Agree
|
34.8 percentage of subjects
|
48.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)
Week 8: Strongly disagree
|
0.0 percentage of subjects
|
4.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)
Week 8: Disagree
|
15.2 percentage of subjects
|
8.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)
Week 8: Neither agree nor disagree
|
17.4 percentage of subjects
|
24.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)
Week 8: Agree
|
39.1 percentage of subjects
|
32.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)
Week 8: Strongly agree
|
28.3 percentage of subjects
|
32.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies subjects evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of anxiety while giving themselves an injection with device. Subjects assessed their anxiety as "Not at all anxious", "A little anxious", "Moderately anxious", "Very anxious", "Extremely anxious". Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)
Week 4: Not at all anxious
|
54.3 percentage of subjects
|
58.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)
Week 4: A little anxious
|
19.6 percentage of subjects
|
26.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)
Week 4: Moderately anxious
|
13.0 percentage of subjects
|
14.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)
Week 4: Very anxious
|
6.5 percentage of subjects
|
2.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)
Week 4: Extremely anxious
|
6.5 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)
Week 8: Not at all anxious
|
47.8 percentage of subjects
|
44.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)
Week 8: A little anxious
|
30.4 percentage of subjects
|
34.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)
Week 8: Moderately anxious
|
8.7 percentage of subjects
|
12.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)
Week 8: Very anxious
|
4.3 percentage of subjects
|
10.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)
Week 8: Extremely anxious
|
8.7 percentage of subjects
|
0.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies subjects evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess whether the trainer provided easily understandable, unbiased and practical information about proper injection. Subjects responded as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree". Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)
Week 4: Strongly disagree
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)
Week 4: Disagree
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)
Week 4: Neither agree nor disagree
|
0.0 percentage of subjects
|
2.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)
Week 4: Agree
|
32.6 percentage of subjects
|
38.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)
Week 4: Strongly agree
|
67.4 percentage of subjects
|
60.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)
Week 8: Strongly disagree
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)
Week 8: Disagree
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)
Week 8: Neither agree nor disagree
|
2.2 percentage of subjects
|
2.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)
Week 8: Agree
|
19.6 percentage of subjects
|
28.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)
Week 8: Strongly agree
|
78.3 percentage of subjects
|
70.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies subjects evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked they would recommend injection device to others needing REBIF therapy. Subjects responded as "Very unlikely", "Unlikely", "Neutral/no opinion", "Likely", "Very likely". Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)
Week 4: Very unlikely
|
2.2 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)
Week 4: Unlikely
|
10.9 percentage of subjects
|
8.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)
Week 4: Neutral/no opinion
|
15.2 percentage of subjects
|
10.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)
Week 4: Likely
|
23.9 percentage of subjects
|
42.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)
Week 4: Very likely
|
47.8 percentage of subjects
|
40.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)
Week 8: Very unlikely
|
4.3 percentage of subjects
|
10.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)
Week 8: Unlikely
|
8.7 percentage of subjects
|
20.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)
Week 8: Neutral/no opinion
|
13.0 percentage of subjects
|
8.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)
Week 8: Likely
|
28.3 percentage of subjects
|
18.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)
Week 8: Very likely
|
45.7 percentage of subjects
|
44.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies subjects evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall satisfaction with using the device. Subjects responded as "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree", "Strongly agree" that they were satisfied with the device. Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)
Week 4: Strongly disagree
|
2.2 percentage of subjects
|
2.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)
Week 4: Disagree
|
15.2 percentage of subjects
|
6.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)
Week 4: Neither agree nor disagree
|
10.9 percentage of subjects
|
8.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)
Week 4: Agree
|
34.8 percentage of subjects
|
54.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)
Week 4: Strongly agree
|
37.0 percentage of subjects
|
30.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)
Week 8: Strongly disagree
|
2.2 percentage of subjects
|
8.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)
Week 8: Disagree
|
4.3 percentage of subjects
|
16.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)
Week 8: Neither agree nor disagree
|
10.9 percentage of subjects
|
16.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)
Week 8: Agree
|
43.5 percentage of subjects
|
20.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)
Week 8: Strongly agree
|
39.1 percentage of subjects
|
40.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Weeks 4 and 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" signifies subjects evaluable for this outcome.
The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as very difficult", "difficult" or "neither easy nor difficult" were reported. Here results are presented by device sequence.
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
|
First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
|
|---|---|---|
|
Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)
Week 8: very difficult
|
2.2 percentage of subjects
|
4.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)
Week 4: very difficult
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)
Week 4: difficult
|
2.2 percentage of subjects
|
6.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)
Week 4: neither easy nor difficult
|
23.9 percentage of subjects
|
14.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)
Week 8: difficult
|
6.5 percentage of subjects
|
14.0 percentage of subjects
|
|
Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)
Week 8: neither easy nor difficult
|
15.2 percentage of subjects
|
18.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline, up to Week 8Population: FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here "Number of Participants Analyzed" = subjects evaluable for this outcome, "Number Analyzed" = subjects evaluable for specified dimensions.
The MusiQoL is a validated 31-item questionnaire describing 9 dimensions named according to its constitutive items:activities of daily living (8 items);psychological well-being (4 items);symptoms (3 items);friends relationships (4 items);family relationships (3 items);satisfaction with health care (RHCS 3 items);sentimental and sexual life (2 items);coping (2 items);and rejection (2 items). Each of the questions was answered using a 6-point Likert scale, defined as 1-Never/Not at all, 2-Rarely/A little, 3-Sometimes/Somewhat, 4-Often/A lot, 5-Always/Very much and 6-Not applicable. The scores of each dimension were obtained by computing mean of the item scores of dimension with negatively worded item scores reversed so that higher scores indicated higher health-related QoL. All 9 dimension scores were linearly transformed to a 0-100 scale,where higher score=higher health-related QoL. Global index score was computed as mean of the 9 dimension scores (range 0-100;higher score=higher QoL).
Outcome measures
| Measure |
First Rebif Rebidose, Then Rebiject II
n=46 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
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First Rebiject II, Then Rebif Rebidose
n=50 Participants
Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
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|---|---|---|
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Baseline:Activities of daily living(ADL)
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69.0 score on a scale
Standard Deviation 23.08
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61.6 score on a scale
Standard Deviation 26.64
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Baseline:Psychological well-being (PWB)
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71.1 score on a scale
Standard Deviation 24.38
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68.2 score on a scale
Standard Deviation 25.20
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Baseline:Symptoms (SPT)
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71.3 score on a scale
Standard Deviation 21.27
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66.1 score on a scale
Standard Deviation 22.84
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Baseline:Friends relationships (RFr)
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66.3 score on a scale
Standard Deviation 19.00
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64.9 score on a scale
Standard Deviation 23.83
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Baseline:Family relationships (RFa)
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81.3 score on a scale
Standard Deviation 19.39
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74.7 score on a scale
Standard Deviation 21.85
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Baseline: RHCS
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63.7 score on a scale
Standard Deviation 29.84
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58.9 score on a scale
Standard Deviation 34.50
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Baseline:Sentimental and sexual life(SSL)
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79.3 score on a scale
Standard Deviation 24.75
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74.0 score on a scale
Standard Deviation 26.28
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Baseline: Coping (COP)
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93.6 score on a scale
Standard Deviation 15.76
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94.3 score on a scale
Standard Deviation 10.60
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Baseline: Rejection (REJ)
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87.4 score on a scale
Standard Deviation 21.37
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88.8 score on a scale
Standard Deviation 14.08
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Baseline: Global index score
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75.3 score on a scale
Standard Deviation 14.52
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72.8 score on a scale
Standard Deviation 14.94
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Change to Week 8: ADL
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2.05 score on a scale
Standard Deviation 13.773
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4.51 score on a scale
Standard Deviation 12.457
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Change to Week 8: PWB
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2.17 score on a scale
Standard Deviation 13.124
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2.98 score on a scale
Standard Deviation 15.832
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Change to Week 8: SPT
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2.99 score on a scale
Standard Deviation 12.271
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3.61 score on a scale
Standard Deviation 15.320
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Change to Week 8: RFr
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-1.02 score on a scale
Standard Deviation 21.746
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0.68 score on a scale
Standard Deviation 23.287
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Change to Week 8: RFa
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-3.15 score on a scale
Standard Deviation 13.211
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-2.54 score on a scale
Standard Deviation 22.213
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Change to Week 8: RHCS
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1.28 score on a scale
Standard Deviation 21.228
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-4.39 score on a scale
Standard Deviation 25.552
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Change to Week 8: SSL
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2.17 score on a scale
Standard Deviation 9.612
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3.26 score on a scale
Standard Deviation 12.482
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Change to Week 8: COP
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0.30 score on a scale
Standard Deviation 10.639
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-0.30 score on a scale
Standard Deviation 10.865
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Change to Week 8: REJ
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0.28 score on a scale
Standard Deviation 19.737
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-0.52 score on a scale
Standard Deviation 12.563
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Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8
Change to Week 8: Global index score
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0.62 score on a scale
Standard Deviation 7.275
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0.87 score on a scale
Standard Deviation 8.204
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Adverse Events
Rebif Rebidose
Rebiject II
Serious adverse events
| Measure |
Rebif Rebidose
n=95 participants at risk
Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2.
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Rebiject II
n=97 participants at risk
Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2.
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|---|---|---|
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Infections and infestations
Staphylococcal osteomyelitis
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1.1%
1/95 • Baseline up to Week 8
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0.00%
0/97 • Baseline up to Week 8
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Other adverse events
| Measure |
Rebif Rebidose
n=95 participants at risk
Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2.
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Rebiject II
n=97 participants at risk
Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2.
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|---|---|---|
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General disorders
Bruising at injection site-Left thigh
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0.00%
0/95 • Baseline up to Week 8
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1.0%
1/97 • Baseline up to Week 8
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General disorders
Dosing error
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0.00%
0/95 • Baseline up to Week 8
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1.0%
1/97 • Baseline up to Week 8
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General disorders
Numbness of right hand
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1.1%
1/95 • Baseline up to Week 8
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0.00%
0/97 • Baseline up to Week 8
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General disorders
Redness
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0.00%
0/95 • Baseline up to Week 8
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1.0%
1/97 • Baseline up to Week 8
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General disorders
Worsening of bunion
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0.00%
0/95 • Baseline up to Week 8
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1.0%
1/97 • Baseline up to Week 8
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General disorders
Post bunionectomy pain
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0.00%
0/95 • Baseline up to Week 8
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1.0%
1/97 • Baseline up to Week 8
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General disorders
Allergic reaction to artificial sweetener (aspartame)
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1.1%
1/95 • Baseline up to Week 8
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0.00%
0/97 • Baseline up to Week 8
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General disorders
Tendonitis Right ring finger/hand
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0.00%
0/95 • Baseline up to Week 8
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1.0%
1/97 • Baseline up to Week 8
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General disorders
Bilateral feet pain
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1.1%
1/95 • Baseline up to Week 8
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0.00%
0/97 • Baseline up to Week 8
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General disorders
Right abdomen wall injection site reaction
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0.00%
0/95 • Baseline up to Week 8
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1.0%
1/97 • Baseline up to Week 8
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Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Results disclosure agreements
- Principal investigator is a sponsor employee PI shall not publish or present any results from the Study to any third parties until i- EMD Serono publishes 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 months following completion of the multi-site study at all sites, whichever comes first. Prior to publishing or presenting results from the study, PI must provide proposed publication to EMD Serono.
- Publication restrictions are in place
Restriction type: OTHER