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

• 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: EMD Serono
• Information provided by: EMD Serono

Tracking Information

• First Submitted Date: August 12, 2009
• First Posted Date: 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: October 2009
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: The Multicenter, Open-label, Single-use Autoinjector Convenience Study
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label)
• Condition: Multiple Sclerosis

Intervention

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 1, 2010): 109
• Original Estimated Enrollment (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

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00958009
• Other Study ID Numbers: 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: EMD Serono
• Collaborators: Not Provided

Investigators

• Study Director: Fernando Dangond, MD; EMD Serono

• PRS Account: EMD Serono
• Verification Date: August 2013