Clinical trial NCT01036165: A Multicenter, Open-label, RebiSmart™ Autoinjector Ease of Use Study
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2009-12-21
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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 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

Primary outcomes:
measure: 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.
timeFrame: at 12 Weeks
Secondary outcomes:
measure: Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes.
timeFrame: at Week 12
Other outcomes:
Locations:
city: Rockland
country: United States
facility: EMD Serono, Inc.
state: Massachusetts
Study officials:
affiliation: EMD Serono
name: Fernando Dangond, MD
role: STUDY_DIRECTOR
References: