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

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00958009
First received: August 12, 2009
Last updated: August 2, 2013
Last verified: August 2013

August 12, 2009
August 2, 2013
October 2009
April 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00958009 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Multicenter, Open-label, Single-use Autoinjector Convenience Study
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)

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).

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Multiple Sclerosis
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
109
June 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00958009
29651
No
Fernando Dangond, , Senior Director, Medical Affairs Neurology, EMD Serono, Inc.
EMD Serono
Not Provided
Study Director: Fernando Dangond, MD EMD Serono, Inc.
EMD Serono
August 2013

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