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Rebif® Rebidose® Versus Rebiject II® Ease-of-Use

A Phase IV, Randomized, Prospective, US-based, Multicenter, Cross-over Study Evaluating Subject Ease-of-use With Rebif® Rebidose® and Rebiject II® Autoinjectors in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With REBIF® 44 mcg Subcutaneously Three Times a Week

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02019550
Enrollment
97
Registered
2013-12-24
Start date
2014-03-31
Completion date
2016-01-31
Last updated
2017-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Relapsing-Remitting, Rebif®Rebidose®, Rebiject II®

Brief summary

This is a Phase 4, prospective, open-label, randomized, cross-over, multicenter trial to evaluate ease-of-use with Rebif® Rebidose® and Rebiject II® autoinjectors in subjects with relapsing remitting multiple sclerosis (RRMS). Subjects will participate in the study for up to 10 weeks (including screening and treatment periods). The treatment period will last 8 weeks and include 12 self-injections using the Rebif® Rebidose® device and 12 self-injections using the Rebiject II® device.

Interventions

DEVICERebif Rebidose

Rebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device.

DEVICERebiject II

Rebif 44 mcg will be injected subcutaneously three times a week using Rebiject II self-injector device.

Sponsors

EMD Serono
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Male and female subjects, 18 to 65 years of age inclusive, at the time of informed consent signature * Diagnosis of RRMS * Receiving Rebif®, 44 microgram subcutaneously three times a week, by manual injection for at least 12 weeks before the screening assessment and previous use of either Rebif® Rebidose® or Rebiject II® devices is acceptable if they have not been using them for the past 12 weeks prior to study entry and if, in the judgment of the investigator, the subjects are not experienced users * Subject is capable of self-injecting using Rebif® Rebidose® and Rebiject II® injection devices * Subject is willing and able to comply with the study procedures for the duration of the trial * Signed, informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization before any trial-related activities are performed * Female subjects of childbearing potential must have a negative pregnancy test at screening to be included in the trial and must be willing to avoid pregnancy by using a highly effective method of contraception * Outpatient status at the time of screening * Stable disease status without a history of surgical procedure or hospitalization within 30 days prior to Study Day 1, and with no surgical intervention planned for the duration of the study

Exclusion criteria

* Received MS therapy other than Rebif® within the 12 weeks before screening or at any time during the trial * Inadequate liver function and bone marrow reserve as defined in the protocol * Current complete transverse myelitis, bilateral optic neuritis, or neuromyelitis optica * History of injection-site necrosis within 12 months before study entry * History of alcohol or drug abuse in the past year * Any autoimmune disorder, except for thyroid disease stable on medication * Subject having moderate to severe renal impairment, in the Investigator's opinion. * Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS * Participation in another clinical trial within the past 30 days or an interventional trial for MS in the past 12 weeks * Use of high-dose steroids within 14 days of screening * Currently experiencing moderate to severe active inflammatory skin disease at sites of expected Rebif® injections * History of clinically significant lipoatrophy at sites of expected Rebif® injections, in the investigator's opinion * Current major depression or suicidal ideation or suicide attempt in the past year * Experiencing spasticity which in the opinion of the Investigator, could interfere with self-injections * Pregnant or lactating * Inability to self-inject or visual impairment which, in the opinion of the Investigator, is severe enough, even with correction, to impede the subject's participation in this study * Upper extremity deficit which, in the opinion of the Investigator, is severe enough to impede the subject's participation in this study * Cognitive deficit which, in the opinion of the Investigator, is severe enough to impede the subject's participation in this study * Subject-reported reason that he/she cannot complete the 8-week study * Any other medical condition, which in the opinion of the Investigator makes the subject unsuitable for this study * Known hypersensitivity to the trial treatment

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 4Week 4The 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.
Percentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 8Week 8The 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.
Percentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) up to Week 8Baseline up to Week 8The 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.

Secondary

MeasureTime frameDescription
Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.
Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.
Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.
Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.
Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.
Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.
Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.
Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.
Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.
Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline, up to Week 8The 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).
Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.
Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.
Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Weeks 4 and 8The 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.

Countries

United States

Participant flow

Recruitment details

The study was conducted at 32 sites in the United States.

Pre-assignment details

Overall, 103 subjects were screened, for inclusion in this trial. Of which, 97 subjects were randomized into the study.

Participants by arm

ArmCount
First Rebif Rebidose, Then Rebiject II
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.
46
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.
51
Total97

Withdrawals & dropouts

PeriodReasonFG000FG001
Treatment Period 1 (4 Weeks)Adverse Event01

Baseline characteristics

CharacteristicFirst Rebif Rebidose, Then Rebiject IIFirst Rebiject II, Then Rebif RebidoseTotal
Age, Continuous49.4 years
STANDARD_DEVIATION 9.78
47.5 years
STANDARD_DEVIATION 11.2
48.4 years
STANDARD_DEVIATION 10.54
Gender
Female
40 Participants32 Participants72 Participants
Gender
Male
6 Participants19 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
3 / 955 / 97
serious
Total, serious adverse events
1 / 950 / 97

Outcome results

Primary

Percentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 4

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.

Time frame: Week 4

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 4Easy34.8 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 4Very easy39.1 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 4Very easy30.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 4Easy50.0 percentage of subjects
Primary

Percentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 8

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.

Time frame: Week 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 8Easy45.7 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 8Very easy30.4 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 8Easy24.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 8Very easy40.0 percentage of subjects
Primary

Percentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) up to Week 8

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.

Time frame: Baseline up to Week 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) up to Week 8Easy29.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) up to Week 8Very easy39.6 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) up to Week 8Very easy30.2 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) up to Week 8Easy47.9 percentage of subjects
Secondary

Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8

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).

Time frame: Baseline, up to Week 8

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline:Psychological well-being (PWB)71.1 score on a scaleStandard Deviation 24.38
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: ADL2.05 score on a scaleStandard Deviation 13.773
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline: RHCS63.7 score on a scaleStandard Deviation 29.84
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: PWB2.17 score on a scaleStandard Deviation 13.124
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline:Symptoms (SPT)71.3 score on a scaleStandard Deviation 21.27
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: SPT2.99 score on a scaleStandard Deviation 12.271
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline:Sentimental and sexual life(SSL)79.3 score on a scaleStandard Deviation 24.75
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: RFr-1.02 score on a scaleStandard Deviation 21.746
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline:Friends relationships (RFr)66.3 score on a scaleStandard Deviation 19
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: RFa-3.15 score on a scaleStandard Deviation 13.211
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: RHCS1.28 score on a scaleStandard Deviation 21.228
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline: Coping (COP)93.6 score on a scaleStandard Deviation 15.76
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: SSL2.17 score on a scaleStandard Deviation 9.612
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline:Activities of daily living(ADL)69.0 score on a scaleStandard Deviation 23.08
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: COP0.30 score on a scaleStandard Deviation 10.639
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline: Rejection (REJ)87.4 score on a scaleStandard Deviation 21.37
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: REJ0.28 score on a scaleStandard Deviation 19.737
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline:Family relationships (RFa)81.3 score on a scaleStandard Deviation 19.39
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: Global index score0.62 score on a scaleStandard Deviation 7.275
First Rebif Rebidose, Then Rebiject IIChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline: Global index score75.3 score on a scaleStandard Deviation 14.52
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: Global index score0.87 score on a scaleStandard Deviation 8.204
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline:Symptoms (SPT)66.1 score on a scaleStandard Deviation 22.84
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: RFa-2.54 score on a scaleStandard Deviation 22.213
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline:Activities of daily living(ADL)61.6 score on a scaleStandard Deviation 26.64
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline:Friends relationships (RFr)64.9 score on a scaleStandard Deviation 23.83
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline:Family relationships (RFa)74.7 score on a scaleStandard Deviation 21.85
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline: RHCS58.9 score on a scaleStandard Deviation 34.5
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline:Sentimental and sexual life(SSL)74.0 score on a scaleStandard Deviation 26.28
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline: Coping (COP)94.3 score on a scaleStandard Deviation 10.6
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline: Rejection (REJ)88.8 score on a scaleStandard Deviation 14.08
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline: Global index score72.8 score on a scaleStandard Deviation 14.94
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: ADL4.51 score on a scaleStandard Deviation 12.457
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: PWB2.98 score on a scaleStandard Deviation 15.832
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: SPT3.61 score on a scaleStandard Deviation 15.32
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: RFr0.68 score on a scaleStandard Deviation 23.287
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: RHCS-4.39 score on a scaleStandard Deviation 25.552
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: SSL3.26 score on a scaleStandard Deviation 12.482
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: COP-0.30 score on a scaleStandard Deviation 10.865
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Change to Week 8: REJ-0.52 score on a scaleStandard Deviation 12.563
First Rebiject II, Then Rebif RebidoseChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8Baseline:Psychological well-being (PWB)68.2 score on a scaleStandard Deviation 25.2
Secondary

Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IINumber 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 disagree0 subjects
First Rebif Rebidose, Then Rebiject IINumber 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 disagree1 subjects
First Rebif Rebidose, Then Rebiject IINumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)Week 8: Disagree0 subjects
First Rebif Rebidose, Then Rebiject IINumber 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 disagree0 subjects
First Rebif Rebidose, Then Rebiject IINumber 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 disagree0 subjects
First Rebif Rebidose, Then Rebiject IINumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)Week 4: Agree6 subjects
First Rebif Rebidose, Then Rebiject IINumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)Week 8: Agree6 subjects
First Rebif Rebidose, Then Rebiject IINumber 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 agree4 subjects
First Rebif Rebidose, Then Rebiject IINumber 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 agree11 subjects
First Rebif Rebidose, Then Rebiject IINumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)Week 4: Disagree0 subjects
First Rebiject II, Then Rebif RebidoseNumber 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 agree8 subjects
First Rebiject II, Then Rebif RebidoseNumber 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 disagree0 subjects
First Rebiject II, Then Rebif RebidoseNumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)Week 4: Disagree0 subjects
First Rebiject II, Then Rebif RebidoseNumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)Week 4: Agree8 subjects
First Rebiject II, Then Rebif RebidoseNumber 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 agree9 subjects
First Rebiject II, Then Rebif RebidoseNumber 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 disagree0 subjects
First Rebiject II, Then Rebif RebidoseNumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)Week 8: Disagree0 subjects
First Rebiject II, Then Rebif RebidoseNumber 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 disagree1 subjects
First Rebiject II, Then Rebif RebidoseNumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)Week 8: Agree7 subjects
First Rebiject II, Then Rebif RebidoseNumber 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 disagree1 subjects
Secondary

Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IINumber 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 disagree2 subjects
First Rebif Rebidose, Then Rebiject IINumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 4: Disagree0 subjects
First Rebif Rebidose, Then Rebiject IINumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 8: Disagree0 subjects
First Rebif Rebidose, Then Rebiject IINumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 4: Agree5 subjects
First Rebif Rebidose, Then Rebiject IINumber 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 disagree1 subjects
First Rebif Rebidose, Then Rebiject IINumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree0 subjects
First Rebif Rebidose, Then Rebiject IINumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 8: Agree8 subjects
First Rebif Rebidose, Then Rebiject IINumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree10 subjects
First Rebif Rebidose, Then Rebiject IINumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree6 subjects
First Rebif Rebidose, Then Rebiject IINumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree1 subjects
First Rebiject II, Then Rebif RebidoseNumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree9 subjects
First Rebiject II, Then Rebif RebidoseNumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree0 subjects
First Rebiject II, Then Rebif RebidoseNumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 4: Disagree0 subjects
First Rebiject II, Then Rebif RebidoseNumber 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 disagree1 subjects
First Rebiject II, Then Rebif RebidoseNumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 4: Agree7 subjects
First Rebiject II, Then Rebif RebidoseNumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree10 subjects
First Rebiject II, Then Rebif RebidoseNumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree0 subjects
First Rebiject II, Then Rebif RebidoseNumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 8: Disagree0 subjects
First Rebiject II, Then Rebif RebidoseNumber 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 disagree3 subjects
First Rebiject II, Then Rebif RebidoseNumber of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)Week 8: Agree9 subjects
Secondary

Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Very anxious6.5 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Moderately anxious8.7 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Very anxious4.3 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage 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 anxious47.8 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Extremely anxious8.7 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Extremely anxious6.5 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage 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 anxious54.3 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 8: A little anxious30.4 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 4: A little anxious19.6 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Moderately anxious13.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 4: A little anxious26.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Moderately anxious12.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Moderately anxious14.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Very anxious2.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Extremely anxious0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage 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 anxious44.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 8: A little anxious34.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Very anxious10.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Extremely anxious0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage 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 anxious58.0 percentage of subjects
Secondary

Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage 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 disagree10.9 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree2.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 4: Disagree2.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 8: Disagree6.5 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 4: Agree39.1 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 8: Agree50.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree47.8 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree41.3 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage 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 disagree0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree46.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 4: Disagree8.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage 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 disagree8.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 4: Agree50.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree34.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree4.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 8: Disagree2.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage 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 disagree4.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)Week 8: Agree44.0 percentage of subjects
Secondary

Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 4: very easy30.4 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 4: very difficult0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 4: easy43.5 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 8: difficult6.5 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 4: difficult4.3 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 8: neither easy nor difficult13.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 8: very difficult0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 4: neither easy nor difficult21.7 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 8: very easy37.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 8: easy43.5 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 8: very easy36.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 4: very difficult0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 4: difficult6.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 4: easy48.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 4: very easy28.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 8: very difficult4.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 8: difficult12.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 8: neither easy nor difficult20.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 8: easy28.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)Week 4: neither easy nor difficult18.0 percentage of subjects
Secondary

Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Week 4: very difficult0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Week 4: difficult2.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Week 4: neither easy nor difficult23.9 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Week 8: very difficult2.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Week 8: difficult6.5 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Week 8: neither easy nor difficult15.2 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Week 8: difficult14.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Week 4: very difficult0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Week 8: very difficult4.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Week 4: difficult6.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Week 8: neither easy nor difficult18.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)Week 4: neither easy nor difficult14.0 percentage of subjects
Secondary

Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 4: Neither agree nor disagree15.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 4: Disagree19.6 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 8: Disagree2.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 8: Neither agree nor disagree4.3 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree30.4 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 8: Agree54.3 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree39.1 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 4: Agree34.8 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree22.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 8: Agree40.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 4: Disagree0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 4: Neither agree nor disagree8.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 4: Agree58.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree34.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree2.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 8: Disagree24.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)Week 8: Neither agree nor disagree12.0 percentage of subjects
Secondary

Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Somewhat inconvenient8.7 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Neutral/no opinion4.3 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Somewhat convenient26.1 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Somewhat inconvenient15.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Somewhat convenient39.1 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Extremely inconvenient0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Extremely convenient60.9 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Extremely inconvenient2.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Neutral/no opinion8.7 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Extremely convenient34.8 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Neutral/no opinion8.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Extremely convenient26.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Neutral/no opinion10.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Somewhat convenient34.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Extremely inconvenient4.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Somewhat inconvenient8.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 8: Extremely convenient46.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Extremely inconvenient2.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Somewhat inconvenient18.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)Week 4: Somewhat convenient44.0 percentage of subjects
Secondary

Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 4: Disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 8: Disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 4: Agree32.6 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage 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 disagree2.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 8: Agree19.6 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree67.4 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree78.3 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage 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 disagree0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree70.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 4: Disagree0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage 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 disagree2.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 4: Agree38.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree60.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 8: Disagree0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage 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 disagree2.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 8: Agree28.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree0.0 percentage of subjects
Secondary

Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 4: Neutral/no opinion15.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 8: Very unlikely4.3 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 4: Unlikely10.9 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 4: Likely23.9 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 8: Neutral/no opinion13.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 4: Very unlikely2.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 8: Likely28.3 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 4: Very likely47.8 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 8: Very likely45.7 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 8: Unlikely8.7 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 8: Very likely44.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 4: Very unlikely0.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 4: Unlikely8.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 4: Neutral/no opinion10.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 4: Likely42.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 4: Very likely40.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 8: Very unlikely10.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 8: Unlikely20.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 8: Neutral/no opinion8.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)Week 8: Likely18.0 percentage of subjects
Secondary

Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 4: Neither agree nor disagree30.4 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 4: Agree34.8 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 4: Disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree34.8 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 8: Disagree15.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 8: Neither agree nor disagree17.4 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 8: Agree39.1 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree28.3 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 8: Neither agree nor disagree24.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 4: Neither agree nor disagree22.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree4.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree32.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree4.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 8: Disagree8.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 4: Disagree6.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 4: Agree48.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 8: Agree32.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree20.0 percentage of subjects
Secondary

Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 4: Disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage 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 disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 8: Disagree6.5 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree0.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage 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 disagree8.7 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 4: Agree52.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 8: Agree45.7 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree2.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree37.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree47.8 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree50.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree2.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage 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 disagree20.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 4: Agree42.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree26.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree4.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 8: Disagree4.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage 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 disagree4.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 8: Agree38.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)Week 4: Disagree10.0 percentage of subjects
Secondary

Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)

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.

Time frame: Weeks 4 and 8

Population: 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.

ArmMeasureGroupValue (NUMBER)
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree2.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 8: Disagree4.3 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree2.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 4: Disagree15.2 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 4: Neither agree nor disagree10.9 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 4: Agree34.8 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree37.0 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 8: Neither agree nor disagree10.9 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 8: Agree43.5 percentage of subjects
First Rebif Rebidose, Then Rebiject IIPercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree39.1 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 8: Strongly agree40.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 4: Strongly agree30.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 8: Strongly disagree8.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 4: Strongly disagree2.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 8: Disagree16.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 4: Disagree6.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 8: Agree20.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 4: Neither agree nor disagree8.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 8: Neither agree nor disagree16.0 percentage of subjects
First Rebiject II, Then Rebif RebidosePercentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)Week 4: Agree54.0 percentage of subjects

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026