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The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.
Primary objective:
- To assess the safe usability of the VIBEX MTX device for subcutaneous (SC) self-injection of methotrexate (MTX) in adult patients with rheumatoid arthritis (RA) after standardized training by site personnel and review of written instructions
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIBEX MTX | Active Comparator | VIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIBEX MTX | Device | Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection | A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device. The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient's performance of essential self-injection steps, including the following:
| 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan J Kivitz, MD;CPI | Altoona Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
All patients received standardized subcutaneous self-injection training per Instructions For Use, then demonstrated the self-injection procedure with practice device and completed the training confirmation questionnaire. And then the subjects were allowed to self-administer the study dose via Vibex MTX.
Subjects were screened & enrolled at 8 sites in the US. There were 20 subjects in 10mg, 30 subjects in 15mg, 31 subjects in 20mg and 20 subjects in 25mg dose group. The dose group was determined by the Investigator based on subject's current therapeutic regimen of MTX and disease status. The patient's dose was the same for the entire study.
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| ID | Title | Description |
|---|---|---|
| FG000 | MTX 10 mg | Self-administration of Subcutaneous Methotrexate using VIBEX MTX |
| FG001 | MTX 15 mg | Self-administration of Subcutaneous Methotrexate using VIBEX MTX |
| FG002 | MTX 20 mg | Self-administration of Subcutaneous Methotrexate using VIBEX MTX |
| FG003 | MTX 25 mg | Self-administration of Subcutaneous Methotrexate using VIBEX MTX |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 101 patients were included in the Safety Population, which consisted of all patients who received study drug and administered a successful or unsuccessful self-injection.
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| ID | Title | Description |
|---|---|---|
| BG000 | MTX 10 mg | Self-administration of Subcutaneous Methotrexate using VIBEX MTX |
| BG001 | MTX 15 mg | Self-administration of Subcutaneous Methotrexate using VIBEX MTX |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection | A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device. The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient's performance of essential self-injection steps, including the following:
| The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, percentages are presented. | Posted | Number | Percentage of Participants | 24 hours |
1 week
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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 | Vibex MTX 10 mg | Self-administration of subcutaneous methotrexate using Vibex MTX |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sick Sinus Syndrome | Cardiac disorders | SOCRA, MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exostosis | Musculoskeletal and connective tissue disorders | SOCRA, MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Jaffe, MD; Vice President-Clinical Development | Antares Pharma Inc. | 609-359-3020 | 324 | jjaffe@antarespharma.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 24 hours |
| Safety of Vibex MTX Device | A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device Injection site assessments were done 0.25 hour, 1 hour, 6 hours and 24 hours after an injection and reported as the following:
| 24 hours |
| Tolerance of Vibex MTX Device (Injection Site Pain Severity as Reported by Patient on VAS Scale - 0 mm = no Pain to 100 mm = Very Severe Pain) | A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device. Visual Analog Scale assessment of injection site pain was reported by patients on 100 mm line immediately after an injection and at 24 hours after injection. | 24 hours |
| BG002 | MTX 20 mg | Self-administration of Subcutaneous Methotrexate using VIBEX MTX |
| BG003 | MTX 25 mg | Self-administration of Subcutaneous Methotrexate using VIBEX MTX |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Vibex MTX 10 mg | Self-administration of subcutaneous methotrexate using Vibex MTX |
| OG001 | Vibex MTX 15 mg | Self-administration of subcutaneous methotrexate using Vibex MTX |
| OG002 | Vibex MTX 20 mg | Self-administration of subcutaneous methotrexate using Vibex MTX |
| OG003 | Vibex MTX 25 mg | Self-administration of subcutaneous methotrexate using Vibex MTX |
|
|
| Secondary | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device
| The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, percentages are presented. | Posted | Number | Percentage of Participants | 24 hours |
|
|
|
| Secondary | Safety of Vibex MTX Device | A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device Injection site assessments were done 0.25 hour, 1 hour, 6 hours and 24 hours after an injection and reported as the following:
| The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, counts and percentages are presented. | Posted | Number | Percentage of Participants | 24 hours |
|
|
|
| Secondary | Tolerance of Vibex MTX Device (Injection Site Pain Severity as Reported by Patient on VAS Scale - 0 mm = no Pain to 100 mm = Very Severe Pain) | A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device. Visual Analog Scale assessment of injection site pain was reported by patients on 100 mm line immediately after an injection and at 24 hours after injection. | The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For continuous data, summary statistics (N, mean, standard deviation, median, minimum, and maximum) were provided. | Posted | Mean | Standard Deviation | mm | 24 hours |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Vibex MTX 15 mg | Self-administration of subcutaneous methotrexate using Vibex MTX | 0 | 30 | 0 | 30 |
| EG002 | Vibex MTX 20 mg | Self-administration of subcutaneous methotrexate using Vibex MTX | 0 | 31 | 1 | 31 |
| EG003 | Vibex MTX 25 mg | Self-administration of subcutaneous methotrexate using Vibex MTX | 1 | 20 | 0 | 20 |
| Headache | Nervous system disorders | SOCRA, MedDRA | Systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Understood the written instructions (%) |
|
| Written instructions were clear & easy to follow % |
|
| Understood the training provided by site staff (%) |
|
| Training by site staff-clear & easy to follow (%) |
|
| Training Confirmation Questions answered right (%) |
|
| Erythema very slight - barely perceptible (%) |
|
| Severity of pain at 24 hours after self-injection |
|