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

Completed · Phase 4

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

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.

Key facts

Study ID: NCT02019550
Run by: EMD Serono
People needed: 97
Starts: 2014-03-01
Expected to finish: 2016-01-01
Last updated by the study team: 2017-03-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research site — Cullman, Alabama, United States
Research Site — Tuscon, Arizona, United States
Research Site — Newport Beach, California, United States
Research site — Fort Collins, Colorado, United States
Research Site — Dover, Delaware, United States
Research Site — Miami, Florida, United States
Research site — Sunrise, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Indianapolis, Indiana, United States
Research site — Foxborough, Massachusetts, United States
Research site — Golden Valley, Minnesota, United States
Research Site — Stratford, New Jersey, United States
Research Site — Patchogue, New York, United States
Research Site — Hickory, North Carolina, United States
Research Site — Winston-Salem, North Carolina, United States
Research Site — Dayton, Ohio, United States
Research Site — Oklahoma City, Oklahoma, United States
Research Site — Greensburg, Pennsylvania, United States
Research site — Spartanburg, South Carolina, United States
Research Site — Knoxville, Tennessee, United States
Research site — Mansfield, Texas, United States

Full record on ClinicalTrials.gov

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