Trial record 17 of 313 for:    "Multiple Sclerosis, Relapsing-Remitting"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by EMD Serono
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT02019550
First received: December 18, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Device: Rebif® Rebidose®
Device: Rebiject II®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Percentage of subjects rating the device as easy to use [ Time Frame: Up to Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects rating the device based on User Trial Questionnaire (UTQ) [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
    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.

  • Percentage of subjects rating the device as very difficult, difficult, neither easy nor difficult, easy, or very easy [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
  • Change from Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) score at Weeks 4 and 8 [ Time Frame: Baseline, Weeks 4 and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rebif® Rebidose®/Rebiject II® 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.
Device: 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.
Experimental: Rebiject II®/Rebif® Rebidose® Device: 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.
Device: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019550

Contacts
Contact: US Medical Information 888-275-7376

Locations
United States, Delaware
Research Site Recruiting
Dover, Delaware, United States
United States, Florida
Research Site Recruiting
Tampa, Florida, United States
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States
United States, Indiana
Research Site Recruiting
Indianapolis, Indiana, United States
United States, New York
Research Site Recruiting
Patchogue, New York, United States
Research Site Recruiting
Plainview, New York, United States
United States, North Carolina
Research Site Recruiting
Hickory, North Carolina, United States
Research Site Recruiting
Winston-Salem, North Carolina, United States
United States, Pennsylvania
Research Site Recruiting
Greensburg, Pennsylvania, United States
United States, Tennessee
Research Site Recruiting
Knoxville, Tennessee, United States
United States, Texas
Research Site Recruiting
Houston, Texas, United States
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Medical Responsible EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT02019550     History of Changes
Other Study ID Numbers: 200136-573
Study First Received: December 18, 2013
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
Multiple Sclerosis, Relapsing-Remitting
Rebif®Rebidose®
Rebiject II®

Additional relevant MeSH terms:
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon beta 1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014