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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Device: Rebif Rebidose; Device: Rebiject II

Study type: Interventional

Funder types: Industry

Identifiers

NCT02019550

200136-573

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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97 participants in 2 patient groups

First Rebif Rebidose, Then Rebiject II

Experimental group

Description:

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.

Treatment:

Device: Rebiject II

Device: Rebif Rebidose

First Rebiject II, Then Rebif Rebidose

Experimental group

Description:

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.

Treatment:

Device: Rebiject II

Device: Rebif Rebidose