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

NCT02019550 | Completed Phase 4 Results

• 1 other identifier: 200136-573
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Relapsing-Remitting; Rebif®Rebidose®; Rebiject II®

Outcome Measures

Primary Outcomes (3)

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

  The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device sequence.

  Week 4

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

  The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device sequence.

  Week 8

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

  The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as "very difficult", "difficult", "neither easy nor difficult", "easy", or "very easy". Percentage of subjects who rated the overall use of device as "easy" or "very easy" were reported. Here results are presented by device used.

  Baseline up to Week 8

Secondary Outcomes (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

• 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

• 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

• 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

Study Arms (2)

First Rebif Rebidose, Then Rebiject II

EXPERIMENTAL

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.

Device: Rebif Rebidose; Device: Rebiject II

First Rebiject II, Then Rebif Rebidose

EXPERIMENTAL

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.

Device: Rebif Rebidose; Device: Rebiject II

Interventions

Rebif Rebidose DEVICE

Rebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device.

First Rebif Rebidose, Then Rebiject II; First Rebiject II, Then Rebif Rebidose

Rebiject II DEVICE

Rebif 44 mcg will be injected subcutaneously three times a week using Rebiject II self-injector device.

First Rebif Rebidose, Then Rebiject II; First Rebiject II, Then Rebif Rebidose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (21)

Research site

Cullman, Alabama, 35058, United States

Location

Research Site

Tuscon, Arizona, 85718, United States

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Newport Beach, California, 92663, United States

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Fort Collins, Colorado, 80528, United States

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Dover, Delaware, 19901, United States

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Miami, Florida, 33136, United States

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Sunrise, Florida, 33351, United States

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Atlanta, Georgia, 30327, United States

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Indianapolis, Indiana, 46256, United States

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Foxborough, Massachusetts, 02035, United States

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Golden Valley, Minnesota, 55422, United States

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Stratford, New Jersey, 08084, United States

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Patchogue, New York, 11772, United States

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Hickory, North Carolina, 28602, United States

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Winston-Salem, North Carolina, 27103, United States

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Dayton, Ohio, 45417, United States

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Oklahoma City, Oklahoma, 73104, United States

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Greensburg, Pennsylvania, 15601, United States

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Spartanburg, South Carolina, 29307, United States

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Knoxville, Tennessee, 37934, United States

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Mansfield, Texas, 76063, United States

Location

Related Publications (1)

• Wray S, Hayward B, Dangond F, Singer B. Ease of use of two autoinjectors in patients with multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: results of the randomized, crossover REDEFINE study. Expert Opin Drug Deliv. 2018 Feb;15(2):127-135. doi: 10.1080/17425247.2018.1407755. Epub 2017 Dec 5.

  PMID: 29206056 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: March 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 7, 2017
• Results First Posted: March 7, 2017

Record last verified: 2017-01

Locations

US (21)