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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebidose® | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. | 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. |
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Inclusion Criteria:
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. All subjects participating in the trial received Rebif 44 mcg subcutaneious (sc, three times per week (tiw) using the single-use autoinjector (SA).
109 subjects were recruited from 12 US clinics in the US during the trial period Oct 2009 to April 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | RMS Subject Disposition | Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | RMS Subject Disposition | Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication |
| 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 | 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 | 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. | Subjects in the all enrolled analysis set who received at least one dose of investigational medicinal product (IMP) were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data. | 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 | RMS Subject Disposition | Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | MedDra 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders | MedDra 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 12 weeks |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. | 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. | Subjects in the all enrolled analysis set who received at least one dose of IMP were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data. | Posted | Mean | 95% Confidence Interval | Proportion of subjects | at 12 weeks |
|
|
|
| 4 |
| 109 |
| 83 |
| 109 |
| Angina pectoris | Cardiac disorders | MedDra 13.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDra 13.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDra 13.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDra 13.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDra 13.0 | Systematic Assessment |
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| Injection site haematoma | General disorders | MedDra 13.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDra 13.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDra 13.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDra 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDra 13.0 | Systematic Assessment |
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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 |
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| Ease of pushing device against skin |
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| Ease of holding device during injection |
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| Able to often or always administer full injection |
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| Satisfaction with size of device |
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| Satisfaction with ease of removing cap from device |
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| Satisfaction with ease of activating button |
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| Satisfaction with time to inject medicine |
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| Satisfaction with ability to see post injection |
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| Rate convenience of device |
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| Rate how reliable injection device was |
|