A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study (Performs)

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT01036165
First received: December 18, 2009
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to test the RebiSmart™ for

  • ease of use
  • multiple domains related to subject's acceptability and satisfaction
  • reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with RMS.

Condition Intervention Phase
Multiple Sclerosis
Device: RebiSmart™
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Twelve-week, Phase IIIb, Open-label, Single-arm, Multicenter Trial to Evaluate Ease of Use of an Electronic Autoinjector (RebiSmart™) for Self-injection in Subjects With Relapsing Multiple Sclerosis (RMS) Treated With Rebif® 44mcg Subcutaneously (sc) Three Times a Week (Tiw)

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • The Primary Endpoint is the Proportion of RMS Subjects Rating the RebiSmart™ Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire. [ Time Frame: at 12 Weeks ] [ Designated as safety issue: No ]
    Data from the User Trial Questionnaire-B, Question 13 (Overall, how do you rate your experience with using the injection device). Mean and confidence intervals refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.


Secondary Outcome Measures:
  • Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
    The User Trial Questionnaire B was administered at Week 6 and Week 12 to assess the ease of use, functional reliability, overall satisfaction, satisfaction with device attributes, convenience, safety and portability of the Rebismart. Means and confidence intervals refer to the proportion of subjects responding positively, based on the number of non-missing values for each question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.


Enrollment: 103
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: RebiSmart™
    The RebiSmart™ autoinjector contains Rebif® 132 mcg multidose cartridges for sc injection.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature
  2. RMS diagnosed according to the McDonald criteria
  3. Currently receiving Rebif® 44mcg sc tiw using manual injections and/or Rebiject II autoinjector for greater than or equal to twelve weeks
  4. Capable of self-injecting using the RebiSmart™ autoinjector. Self- injecting is defined as being able to make 2 of the 3 weekly injections without assistance.
  5. Be willing and able to comply with the study procedures for the duration of the trial
  6. Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out
  7. Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either:

    • Being post-menopausal or surgically sterile, or using a highly effective method of contraception (defined as a method that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, and includes for instance, implants, injectables, combined oral contraceptives*, some intrauterine devices, sexual abstinence or vasectomised partner)
    • Female subjects of childbearing potential must have a negative pregnancy test at Screening and Study Day 1 to be included in the trial. A urine pregnancy test will also be done at the Week 12/Exit visit

      • Note for subjects using a hormonal contraceptive method: No formal drug interaction studies have been carried out with Rebif®. As interferons have been reported to exert an inhibitory activity on hepatic microsomal enzymes, it is unlikely that the clearance of oral contraceptives would increase and result in decreased efficacy. In over 10,000 patient years of clinical trial experience with Rebif®, there has never been any indication of an interaction with oral contraceptives.

Exclusion Criteria:

  1. Have used any other injectable medications (e.g. for pain) on a regular basis during the week prior to Screening or throughout the duration of the trial (the administration of a single injection for treatment or prophylaxis of a condition unrelated to MS or Rebif® therapy (e.g., influenza or pneumococcus vaccination) will be acceptable)
  2. Have received MS therapy other than Rebif® within twelve weeks prior to Screening or at any time during the trial (e.g., other disease modifying drugs, Rebif® New Formulation, combination therapy, immunomodulatory and/or immunosuppressive agents, including but not limited to any other interferon (Avonex/Betaseron/Extavia), glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, fingolimod (FTY720), total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (e.g. natalizumab, alemtuzumab/Campath, anti-CD4), Intravenous immunoglobulin (IVIg), cytokines or anti-cytokine therapy) and telbivudine
  3. Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN), or alkaline phosphatase > 2.5x ULN, or total bilirubin > 2.5x ULN
  4. Have inadequate bone marrow reserve, defined as a total white blood cell count < 3.0x 109/L, platelet count < 75x109/L, hemoglobin < 100g/L
  5. Have complete transverse myelitis or simultaneous-onset bilateral optic neuritis
  6. Have a history of alcohol or drug abuse
  7. Have thyroid dysfunction
  8. Have moderate to severe renal impairment
  9. Have a major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
  10. Have a history of seizures not adequately controlled by treatment
  11. Have serious or acute cardiac disease, such as uncontrolled dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
  12. Have, in the opinion of the investigator, major visual, physical or cognitive impairment that would preclude the subject from self-injecting with the RebiSmart™ autoinjector
  13. Have a known hypersensitivity or allergy to interferon-beta or any of the excipients
  14. Have participated in another clinical trial within the past thirty days
  15. Are pregnant or attempting to conceive
  16. Have previously used a RebiSmart™ autoinjector
  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: NCT01036165

Locations
United States, Massachusetts
EMD Serono, Inc.
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Fernando Dangond, MD EMD Serono, Inc.
  More Information

No publications provided

Responsible Party: Ahmad Al-Sabbagh, Vice President Medical Affairs Neurology, EMD Serono, Inc.
ClinicalTrials.gov Identifier: NCT01036165     History of Changes
Other Study ID Numbers: 29652
Study First Received: December 18, 2009
Results First Received: November 30, 2010
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 20, 2014