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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

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 Relapsing Remitting Multiple Sclerosis (RRMS) Treated With REBIF® 44 mcg Subcutaneously Three Times a Week

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019550
• Other study ID #: 200136-573
• Status: Completed
• Phase: Phase 4
• First received: December 18, 2013
• Last updated: March 29, 2016
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Device:
• Rebif® Rebidose®
Rebif® will be administered at a dose of 44 microgram (mcg) subcutaneously three times a week (12 injections) by using Rebif® Rebidose® self-injector device in Period 1 (4 weeks). Total treatment duration will be of 8 weeks.
• Rebiject II®
Subjects who will receive Rebif® by using Rebif® Rebidose® in Period 1 will be receiving Rebif® at a dose of 44 mcg subcutaneously three times a week (12 injections) by using Rebiject II® self-injector device in Period 2 (4 weeks). Total treatment duration will be of 8 weeks.
• Rebiject II®
Rebif® will be administered at a dose of 44 mcg subcutaneously three times a week (12 injections) by using Rebiject II® self-injector device in Period 1 (4 weeks). Total treatment duration will be of 8 weeks.
• Rebif® Rebidose®
Subjects who will receive Rebif® by using Rebiject II® in Period 1 will be receiving Rebif® at a dose of 44 mcg subcutaneously three times a week (12 injections) by using Rebif® Rebidose® self-injector device in Period 2 (4 weeks). Total treatment duration will be of 8 weeks.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects rating the device as easy to use		Up to Week 8	No
Secondary	Percentage of subjects rating the device based on User Trial Questionnaire (UTQ)	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.	Weeks 4 and 8	No
Secondary	Percentage of subjects rating the device as very difficult, difficult, neither easy nor difficult, easy, or very easy		Weeks 4 and 8	No
Secondary	Change from Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) score at Weeks 4 and 8		Baseline, Weeks 4 and 8	No