Rebif® Rebidose® Versus Rebiject II® Ease-of-Use
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Rebif Rebidose; Rebiject II
Intervention description: Rebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device.; Rebif 44 mcg will be injected subcutaneously three times a week using Rebiject II self-injector device.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis, Relapsing-Remitting; Rebif®Rebidose®; Rebiject II®

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.
    

Eligibility 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