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

Tracking Information
First Submitted Date ICMJE	August 12, 2009
First Posted Date ICMJE	August 13, 2009
Results First Submitted Date	December 1, 2010
Results First Posted Date	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	Complete list of historical versions of study NCT00958009 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	Phase 3
Study Design ICMJE	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	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	June 2010
Actual Primary Completion Date	April 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature; RMS diagnosed according to the McDonald criteria; Currently receiving Rebif® 44mcg sc tiw using manual injections and/or Rebiject II autoinjector for greater than twelve weeks; Capable of self-injecting using the single-use autoinjector; Be willing and able to comply with the study procedures for the duration of the trial; Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study-related activities are carried out; Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential Exclusion Criteria: 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); 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; 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; Have inadequate bone marrow reserve, defined as a total white blood cell count < 3.0x 109/L, platelet count < 75x109/L, haemoglobin < 100g/L; Have complete transverse myelitis or bilateral optic neuritis; Have a history of alcohol or drug abuse; Have thyroid dysfunction; Have moderate to severe renal impairment; 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; Have a history of seizures not adequately controlled by treatment; Have serious or acute cardiac disease, such as uncontrolled dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure; 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; Have a known hypersensitivity or allergy to interferon-beta or any of the excipients; Have participated in another clinical trial within the past thirty days; Are pregnant or attempting to conceive
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	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	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