Rebif® Rebidose® Versus Rebiject II® Ease-of-Use | NCT02019550

Label	Type	Description	Intervention Names
First Rebif Rebidose, Then Rebiject II	Experimental	Subjects will self-inject Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 (4 weeks) for the next 4 weeks.	Device: Rebif Rebidose Device: Rebiject II
First Rebiject II, Then Rebif Rebidose	Experimental	Subjects will self-inject 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.	Device: Rebif Rebidose Device: Rebiject II

Name	Type	Description	Arm Group Labels	Other Names
Rebif Rebidose	Device	Rebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device.	First Rebif Rebidose, Then Rebiject II

Measure	Description	Time Frame
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.	Week 4
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.	Week 8
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.	Baseline up to Week 8

Measure	Description	Time Frame
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.

Name	Affiliation	Role
Medical Responsible	EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research site		Cullman	Alabama	35058	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
29206056	Derived	Wray S, Hayward B, Dangond F, Singer B. Ease of use of two autoinjectors in patients with multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: results of the randomized, crossover REDEFINE study. Expert Opin Drug Deliv. 2018 Feb;15(2):127-135. doi: 10.1080/17425247.2018.1407755. Epub 2017 Dec 5.

ID	Title	Description
FG000	First Rebif Rebidose, Then Rebiject II	Subjects self-injected Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

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.

Posted

Number

percentage of subjects

Week 4

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG00046 OG00150

Title

Denominators

Categories

Easy

Title	Measurements
	OG00034.8 OG00150.0

Very easy

Title	Measurements
	OG000

Primary

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

Posted

Number

percentage of subjects

Week 8

ID	Title	Description
OG000	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.
OG001	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.

Primary

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

Posted

Number

percentage of subjects

Baseline up to Week 8

ID	Title	Description
OG000	Rebif Rebidose	Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2.
OG001	Rebiject II	Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2.

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.

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.

Posted

Number

subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Number

percentage of subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Number

percentage of subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Number

percentage of subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Number

subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Number

percentage of subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

Posted

Number

percentage of subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Number

percentage of subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Number

percentage of subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Number

percentage of subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Number

percentage of subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Number

percentage of subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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.

Posted

Number

percentage of subjects

Weeks 4 and 8

ID	Title	Description
OG000	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.
OG001	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.

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).

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline, up to Week 8

ID	Title	Description
OG000	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.

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rebif Rebidose	Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2.			1	95	3	95
EG001	Rebiject II	Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2.			0	97	5	97

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bruising at injection site-Left thigh	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected95 at risk EG0011 affected97 at risk
Dosing error	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected95 at risk EG0011 affected97 at risk
Numbness of right hand	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected95 at risk EG0010 affected97 at risk
Redness	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected95 at risk EG0011 affected97 at risk
Worsening of bunion	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected95 at risk EG0011 affected97 at risk
Post bunionectomy pain	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected95 at risk EG0011 affected97 at risk
Allergic reaction to artificial sweetener (aspartame)	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected95 at risk EG0010 affected97 at risk
Tendonitis Right ring finger/hand	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected95 at risk EG0011 affected97 at risk
Bilateral feet pain	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0001 affected95 at risk EG0010 affected97 at risk
Right abdomen wall injection site reaction	General disorders	MedDRA 16.1	Non-systematic Assessment	EG0000 affected95 at risk EG0011 affected97 at risk

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups