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

CompletedPhase 4Relapsing MSNCT02019550

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Rebif Rebidose
  • Rebiject II

Results by group

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

Week 4

GroupValueIntervalNumber analysed
First Rebif Rebidose, Then Rebiject II34.8 percentage of subjects46
First Rebiject II, Then Rebif Rebidose50.0 percentage of subjects50
First Rebif Rebidose, Then Rebiject II39.1 percentage of subjects46
First Rebiject II, Then Rebif Rebidose30.0 percentage of subjects50

First Rebif Rebidose, Then Rebiject II

34.8

First Rebiject II, Then Rebif Rebidose

50

First Rebif Rebidose, Then Rebiject II

39.1

First Rebiject II, Then Rebif Rebidose

30

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

Week 8

GroupValueIntervalNumber analysed
First Rebif Rebidose, Then Rebiject II45.7 percentage of subjects46
First Rebiject II, Then Rebif Rebidose24.0 percentage of subjects50
First Rebif Rebidose, Then Rebiject II30.4 percentage of subjects46
First Rebiject II, Then Rebif Rebidose40.0 percentage of subjects50

First Rebif Rebidose, Then Rebiject II

45.7

First Rebiject II, Then Rebif Rebidose

24

First Rebif Rebidose, Then Rebiject II

30.4

First Rebiject II, Then Rebif Rebidose

40

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

Baseline up to Week 8

GroupValueIntervalNumber analysed
Rebif Rebidose29.2 percentage of subjects96
Rebiject II47.9 percentage of subjects96
Rebif Rebidose39.6 percentage of subjects96
Rebiject II30.2 percentage of subjects96

Rebif Rebidose

29.2

Rebiject II

47.9

Rebif Rebidose

39.6

Rebiject II

30.2

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Rebif Rebidose951 (1.1%)
Rebiject II970 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

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

    Week 4

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

    Week 8

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

    Baseline up to Week 8

Other measures (14)

  • 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 8

    Quality of life (reported by participants)

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

    Weeks 4 and 8

    Quality of life (reported by participants)

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

    Weeks 4 and 8

    Quality of life (reported by participants)

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

    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)

    Weeks 4 and 8

    Quality of life (reported by participants)

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

    Weeks 4 and 8

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

    Weeks 4 and 8

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

    Weeks 4 and 8

    Safety

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

    Weeks 4 and 8

    Mood and sleep

  • 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 8

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 to 65

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Mar 2014

    2. Main results due

      Jan 2016

    3. Finished

      Jan 2016

    4. Results posted

      Mar 2017

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