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The Multicenter, Open-label, Single-use Autoinjector Convenience Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00958009
Recruitment Status : Completed
First Posted : August 13, 2009
Results First Posted : December 30, 2010
Last Update Posted : August 7, 2013
Sponsor:
Information provided by:
EMD Serono

Tracking Information
First Submitted Date  ICMJE August 12, 2009
First Posted Date  ICMJE August 13, 2009
Results First Submitted Date  ICMJE December 1, 2010
Results First Posted Date  ICMJE December 30, 2010
Last Update Posted Date August 7, 2013
Study Start Date  ICMJE October 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2011)
Proportion of Relapsing Multiple Sclerosis (RMS) Subjects Rating the Single-use Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire [ Time Frame: at 12 weeks ]
Data from the User Trial Questionnaire, Question 14 (Overall, how do you rate your experience with using the injection device?) Mean and confidence interval refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.
Original Primary Outcome Measures  ICMJE
 (submitted: August 12, 2009)
Proportion of RMS Subjects Rating the Single-use Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire [ Time Frame: at 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2011)
Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. [ Time Frame: at 12 weeks ]
The User Trial Questionnaire was used to assess the ease of use, functional reliability, overall satisfaction with device attributes, convenience, safety and portability of the device. Mean and confidence intervals refer to proportion of subjects responding positively to question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2009)
Multiple secondary endpoints will be assessed, based on questions from the User Trial Questionnaire at Study Day 1, Week 6 and Week 12/Exit, related to the single-use autoinjector device use-related outcomes. [ Time Frame: at 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Multicenter, Open-label, Single-use Autoinjector Convenience Study
Official Title  ICMJE A Twelve-week, Phase IIIb, Open-label, Single-arm, Multicenter Trial to Evaluate Ease of Use of a Ready-to-use, Single-use Autoinjector (SA) for Self-injection in Subjects With Relapsing Multiple Sclerosis (RMS) Treated With Rebif® 44mcg Subcutaneously (sc), Three Times a Week (Tiw)
Brief Summary The purpose of this trial is to test the Single-Use Autoinjector for a) ease of use; b) multiple domains related to subject's acceptability and satisfaction, and c) reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with relapsing multiple sclerosis (RMS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Device: Rebidose®
The device is a ready to use single use auto injector containing Rebif® 44 mcg in a 0.5 mL prefilled syringe for sc injection
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 1, 2010)
109
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2009)
100
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 twelve weeks
  4. Capable of self-injecting using the single-use autoinjector
  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

Exclusion Criteria:

  1. Have used any other injectable medications (i.e. 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 interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, 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, haemoglobin < 100g/L
  5. Have complete transverse myelitis or 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, any visual, physical or cognitive impairment that would preclude the subject from self-injecting with the single-use 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00958009
Other Study ID Numbers  ICMJE 29651
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fernando Dangond, , Senior Director, Medical Affairs Neurology, EMD Serono, Inc.
Study Sponsor  ICMJE EMD Serono
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fernando Dangond, MD EMD Serono
PRS Account EMD Serono
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP