Clinical Trial: Rebif® Rebidose® Versus Rebiject II® Ease-of-Use

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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.

Detailed Summary:
Sponsor: EMD Serono

Current Primary Outcome:

  • Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 4 [ Time Frame: 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.
  • Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) at Week 8 [ Time Frame: 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.
  • Percentage of Subjects Rating Each Device as "Easy/Very Easy to Use" Based on User Trial Questionnaire (UTQ) up to Week 8 [ Time Frame: Baseline 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"

    Original Primary Outcome: Percentage of subjects rating the device as easy to use [ Time Frame: Up to Week 8 ]

    Current Secondary Outcome:

    • Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ) [ Time Frame: Weeks 4 and 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 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 Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ) [ Time Frame: Weeks 4 and 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 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) [ Time Frame: Weeks 4 and 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 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.
    • Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ) [ Time Frame: Weeks 4 and 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 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) [ Time Frame: Weeks 4 and 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 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) [ Time Frame: Weeks 4 and 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 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) [ Time Frame: Weeks 4 and 8 ]
      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.
    • Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ) [ Time Frame: Weeks 4 and 8 ]
      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.
    • Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ) [ Time Frame: Weeks 4 and 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 level of anxiety while giving themselves an injection with device. Subjects assessed their anxiety as "Not at all anxious", "A little anxious"

      Original Secondary Outcome:

      • Percentage of subjects rating the device based on User Trial Questionnaire (UTQ) [ Time Frame: Weeks 4 and 8 ]
        The User Trial Questionnaire will be used to assess the ease of use, functional reliability, overall satisfaction with device attributes, convenience, use-safety and portability of the device.
      • Percentage of subjects rating the device as very difficult, difficult, neither easy nor difficult, easy, or very easy [ Time Frame: Weeks 4 and 8 ]
      • Change from Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) score at Weeks 4 and 8 [ Time Frame: Baseline, Weeks 4 and 8 ]


      Information By: EMD Serono

      Dates:
      Date Received: December 18, 2013
      Date Started: March 2014
      Date Completion:
      Last Updated: January 13, 2017
      Last Verified: January 2017