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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Device: Rebif Rebidose
* Device: Rebiject II


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First Rebif Rebidose, Then Rebiject II<br>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<br>* Rebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device.<br>Device: Rebiject II<br>* Rebif 44 mcg will be injected subcutaneously three times a week using Rebiject II self-injector device.<br>|
| Experimental: First Rebiject II, Then Rebif Rebidose<br>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<br>* Rebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device.<br>Device: Rebiject II<br>* Rebif 44 mcg will be injected subcutaneously three times a week using Rebiject II self-injector device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Weeks 4 and 8 | 
| 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. | Weeks 4 and 8 | 
| 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. | Weeks 4 and 8 | 
| 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. | Weeks 4 and 8 | 
| 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. | Weeks 4 and 8 | 
| 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. | Weeks 4 and 8 | 
| 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. | Weeks 4 and 8 | 
| 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. | Weeks 4 and 8 | 
| 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. | Weeks 4 and 8 | 
| 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. | Weeks 4 and 8 | 
| 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. | Weeks 4 and 8 | 
| 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. | Weeks 4 and 8 | 
| 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. | Weeks 4 and 8 | 
| 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). | Baseline, up to Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Relapsing-Remitting, Rebif®Rebidose®, Rebiject II®