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The purpose of this study is to test the RebiSmartâ„¢ for
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RebiSmart™ | Device | The RebiSmart™ autoinjector contains Rebif® 132 mcg multidose cartridges for sc injection. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Endpoint is the Proportion of RMS Subjects Rating the RebiSmartâ„¢ 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. | at 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmartâ„¢ 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. |
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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 or equal to twelve weeks
Capable of self-injecting using the RebiSmartâ„¢ autoinjector. Self- injecting is defined as being able to make 2 of the 3 weekly injections without assistance.
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, 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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Dangond, MD | EMD Serono | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EMD Serono, Inc. | Rockland | Massachusetts | 02370 | United States |
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.
103 subjects were recruited from 15 US clinics in the US during the trial period February 2010 to August 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Subject Disposition | Intent-to-Treat Analysis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subject Disposition | Intent-to-Treat Analysis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Endpoint is the Proportion of RMS Subjects Rating the RebiSmartâ„¢ 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. | Posted | Mean | 95% Confidence Interval | Proportion of subjects | at 12 Weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subject Disposition | Intent-to-Treat Analysis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders | Medra 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fernando Dangond, MD | EMD Serono, Inc. | 781-681-2348 | Fernando.dangond@emdserono.com |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| at Week 12 |
| Device Related Issues |
|
| Problems finding proper area to inject |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Multiple Secondary Endpoints Will be Assessed, Based on Questions From the User Trial Questionnaire Related to the RebiSmartâ„¢ 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. | Posted | Mean | 95% Confidence Interval | Percentage of subjects | at Week 12 |
|
|
|
| 1 |
| 99 |
| 92 |
| 103 |
| Nephrolithiasis | Renal and urinary disorders | Medra 13.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Injection site haematoma | General disorders | Medra 13.0 | Systematic Assessment |
|
| Injection Site Pain | General disorders | Medra 13.0 | Systematic Assessment |
|
| Urinary Tract Infection | General disorders | Medra 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | Medra 13.0 | Systematic Assessment |
|
| Multiple Sclerosis relapse | Nervous system disorders | Medra 13.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | Medra 13.0 | Systematic Assessment |
|
Neither Institution nor any Principal Investigators shall publish or present any results from such Study to any third parties until: (i) EMD Serono publishes the results from all sites participating in such Study; (ii) Institution receives notification from EMD Serono that publication of the multi-site results is no longer planned; or (iii) twenty-four (24) months following the completion of the multi-site study at all sites, whichever occurs first.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| Step by step Instructions are a key benefit |
|
| Ease of using injection device |
|
| Ease of loading cartridge |
|
| Ease of inserting the needle |
|
| Ease of pushing the button |
|
| Ease of holding device during injection |
|
| Ease of removing the needle from device |
|
| Able to often or always administer full injection |
|
| Rate the convenience of the device |
|