Multiple Sclerosis
Conditions
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.
Interventions
DEVICERebiSmart™
The RebiSmart™ autoinjector contains Rebif® 132 mcg multidose cartridges for sc injection.
Sponsors
EMD Serono
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | at 12 Weeks | Data from the User Trial Questionnaire-B, Question 13 (Overall, how do you rate your experience with using the injection device). Mean and confidence intervals refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | at Week 12 | The User Trial Questionnaire B was administered at Week 6 and Week 12 to assess the ease of use, functional reliability, overall satisfaction, satisfaction with device attributes, convenience, safety and portability of the Rebismart. Means and confidence intervals refer to the proportion of subjects responding positively, based on the number of non-missing values for each question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed. |
Countries
United States
Participant flow
Recruitment details
103 subjects were recruited from 15 US clinics in the US during the trial period February 2010 to August 2010
Pre-assignment details
Subjects who signed informed consent and satisfied the eligibility critera at screening returned to the clinic on study day 1 to begin treatment with the Rebismart autoinjector. All subjects participating in the trial received Rebif 44 mcg sc tiw using the Rebismart autoinjector for 12 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Subject Disposition Intent-to-Treat Analysis | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Device Related Issues | 3 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Problems finding proper area to inject | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Subject Disposition |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 103 Participants |
| Age Continuous | 46.4 years STANDARD_DEVIATION 9.35 |
| Region of Enrollment United States | 103 participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 92 / 103 |
| serious Total, serious adverse events | 1 / 99 |
Outcome results
Primary
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.
Data from the User Trial Questionnaire-B, Question 13 (Overall, how do you rate your experience with using the injection device). Mean and confidence intervals refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.
Time frame: at 12 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Subject Disposition | 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. | 0.78 Proportion of subjects |
95% CI: [0.7, 0.86]
Secondary
Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes.
The User Trial Questionnaire B was administered at Week 6 and Week 12 to assess the ease of use, functional reliability, overall satisfaction, satisfaction with device attributes, convenience, safety and portability of the Rebismart. Means and confidence intervals refer to the proportion of subjects responding positively, based on the number of non-missing values for each question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.
Time frame: at Week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Subject Disposition | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | Device makes injections simple | 81.8 Percentage of subjects |
| Subject Disposition | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | Allows easy access to skin injection sites | 79.5 Percentage of subjects |
| Subject Disposition | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | Helps me self-administer Injections | 84.1 Percentage of subjects |
| Subject Disposition | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | Step by step Instructions are a key benefit | 93.2 Percentage of subjects |
| Subject Disposition | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | Ease of using injection device | 90.9 Percentage of subjects |
| Subject Disposition | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | Ease of loading cartridge | 97.7 Percentage of subjects |
| Subject Disposition | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | Ease of inserting the needle | 84.1 Percentage of subjects |
| Subject Disposition | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | Ease of pushing the button | 96.6 Percentage of subjects |
| Subject Disposition | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | Ease of holding device during injection | 84.1 Percentage of subjects |
| Subject Disposition | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | Ease of removing the needle from device | 76.1 Percentage of subjects |
| Subject Disposition | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | Able to often or always administer full injection | 98.9 Percentage of subjects |
| Subject Disposition | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmart™ Autoinjector Use-related Outcomes. | Rate the convenience of the device | 87.5 Percentage of subjects |