Rheumatoid Arthritis (RA)
Conditions
Brief summary
The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.
Detailed description
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: * To evaluate the reliability and robustness of the VIBEX MTX device * To evaluate the safety and local tolerance of an SC self-injection of MTX using the VIBEX MTX device * To evaluate the effectiveness and ease of use of the VIBEX MTX device patient education tools for SC self-injection
Interventions
DEVICEVIBEX MTX
Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device
Sponsors
Antares Pharma Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients \>18 years of age, diagnosed with Rheumatoid Arthritis
Exclusion criteria
* Pregnant females * Any other clinically significant disease or disorder which, in the opinion of the investigator might put the subject at risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 24 hours | 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: 1. SC self-injection was administered by the patient 2. SC self-injection was intentional 3. self-injection was administered in an appropriate location on the abdomen 4. patient removed cap marked 1 5. patient removed cap marked 2 6. patient held device at injection site for 3 seconds 7. patient confirmed that the window was obstructed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | 24 hours | 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 1. Ease of use Questionnaire was completed by patients immediately after self-injection 2. Training confirmation questionnaire was completed by patients after the training and then reviewed with PI or site coordinator |
| Safety of Vibex MTX Device | 24 hours | 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: * Erythema - 0 = None * Erythema - 1 = Very slight, barely perceptible * Erythema - 2 = Obvious, but well defined * Erythema - 3 = Moderate to severe * Erythema - 4 = Severe |
| 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) | 24 hours | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| MTX 10 mg Self-administration of Subcutaneous Methotrexate using VIBEX MTX | 20 |
| MTX 15 mg Self-administration of Subcutaneous Methotrexate using VIBEX MTX | 30 |
| MTX 20 mg Self-administration of Subcutaneous Methotrexate using VIBEX MTX | 31 |
| MTX 25 mg Self-administration of Subcutaneous Methotrexate using VIBEX MTX | 20 |
| Total | 101 |
Baseline characteristics
| Characteristic | MTX 15 mg | Total | MTX 10 mg | MTX 25 mg | MTX 20 mg |
|---|---|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 9 | 60.9 years STANDARD_DEVIATION 10.14 | 63.5 years STANDARD_DEVIATION 11.46 | 59.1 years STANDARD_DEVIATION 9.92 | 59.5 years STANDARD_DEVIATION 10.46 |
| BMI | 31.3 kg/m^2 STANDARD_DEVIATION 7.26 | 30.9 kg/m^2 STANDARD_DEVIATION 6.64 | 31.4 kg/m^2 STANDARD_DEVIATION 7.54 | 30.3 kg/m^2 STANDARD_DEVIATION 5.28 | 30.5 kg/m^2 STANDARD_DEVIATION 6.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 98 Participants | 19 Participants | 20 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 7 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 29 Participants | 93 Participants | 18 Participants | 19 Participants | 27 Participants |
| Region of Enrollment United States | 30 participants | 101 participants | 20 participants | 20 participants | 31 participants |
| Sex: Female, Male Female | 20 Participants | 80 Participants | 18 Participants | 16 Participants | 26 Participants |
| Sex: Female, Male Male | 10 Participants | 21 Participants | 2 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 30 | 1 / 31 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 30 | 0 / 31 | 1 / 20 |
Outcome results
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: 1. SC self-injection was administered by the patient 2. SC self-injection was intentional 3. self-injection was administered in an appropriate location on the abdomen 4. patient removed cap marked 1 5. patient removed cap marked 2 6. patient held device at injection site for 3 seconds 7. patient confirmed that the window was obstructed
Time frame: 24 hours
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vibex MTX 10 mg | 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 | SC self-injection was administered by patient (%) | 100 Percentage of Participants |
| Vibex MTX 10 mg | 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 | Patient removed cap marked 1 (%) | 100 Percentage of Participants |
| Vibex MTX 10 mg | 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 | SC self-injection was in abdomen (%) | 100 Percentage of Participants |
| Vibex MTX 10 mg | 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 | Patient confirmed that window was obstructed (%) | 100 Percentage of Participants |
| Vibex MTX 10 mg | 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 | Patient held device at injection site > 3 sec (%) | 100 Percentage of Participants |
| Vibex MTX 10 mg | 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 | Patient removed cap marked 2 (%) | 100 Percentage of Participants |
| Vibex MTX 10 mg | 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 | SC self-injection was intentional (%) | 100 Percentage of Participants |
| Vibex MTX 15 mg | 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 | Patient removed cap marked 2 (%) | 100 Percentage of Participants |
| Vibex MTX 15 mg | 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 | SC self-injection was administered by patient (%) | 100 Percentage of Participants |
| Vibex MTX 15 mg | 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 | SC self-injection was intentional (%) | 100 Percentage of Participants |
| Vibex MTX 15 mg | 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 | SC self-injection was in abdomen (%) | 100 Percentage of Participants |
| Vibex MTX 15 mg | 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 | Patient removed cap marked 1 (%) | 100 Percentage of Participants |
| Vibex MTX 15 mg | 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 | Patient held device at injection site > 3 sec (%) | 100 Percentage of Participants |
| Vibex MTX 15 mg | 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 | Patient confirmed that window was obstructed (%) | 100 Percentage of Participants |
| Vibex MTX 20 mg | 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 | SC self-injection was intentional (%) | 100 Percentage of Participants |
| Vibex MTX 20 mg | 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 | Patient removed cap marked 1 (%) | 100 Percentage of Participants |
| Vibex MTX 20 mg | 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 | Patient removed cap marked 2 (%) | 100 Percentage of Participants |
| Vibex MTX 20 mg | 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 | SC self-injection was administered by patient (%) | 100 Percentage of Participants |
| Vibex MTX 20 mg | 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 | Patient confirmed that window was obstructed (%) | 100 Percentage of Participants |
| Vibex MTX 20 mg | 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 | Patient held device at injection site > 3 sec (%) | 100 Percentage of Participants |
| Vibex MTX 20 mg | 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 | SC self-injection was in abdomen (%) | 100 Percentage of Participants |
| Vibex MTX 25 mg | 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 | SC self-injection was intentional (%) | 100 Percentage of Participants |
| Vibex MTX 25 mg | 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 | Patient confirmed that window was obstructed (%) | 100 Percentage of Participants |
| Vibex MTX 25 mg | 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 | Patient held device at injection site > 3 sec (%) | 100 Percentage of Participants |
| Vibex MTX 25 mg | 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 | Patient removed cap marked 1 (%) | 100 Percentage of Participants |
| Vibex MTX 25 mg | 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 | SC self-injection was administered by patient (%) | 100 Percentage of Participants |
| Vibex MTX 25 mg | 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 | SC self-injection was in abdomen (%) | 100 Percentage of Participants |
| Vibex MTX 25 mg | 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 | Patient removed cap marked 2 (%) | 100 Percentage of Participants |
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 1. Ease of use Questionnaire was completed by patients immediately after self-injection 2. Training confirmation questionnaire was completed by patients after the training and then reviewed with PI or site coordinator
Time frame: 24 hours
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vibex MTX 10 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Device was easy to use (%) | 95 Percentage of Participants |
| Vibex MTX 10 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Understood the written instructions (%) | 100 Percentage of Participants |
| Vibex MTX 10 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Written instructions were clear & easy to follow % | 100 Percentage of Participants |
| Vibex MTX 10 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Understood the training provided by site staff (%) | 100 Percentage of Participants |
| Vibex MTX 10 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Training by site staff-clear & easy to follow (%) | 100 Percentage of Participants |
| Vibex MTX 10 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Training Confirmation Questions answered right (%) | 90 Percentage of Participants |
| Vibex MTX 15 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Training by site staff-clear & easy to follow (%) | 100 Percentage of Participants |
| Vibex MTX 15 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Device was easy to use (%) | 100 Percentage of Participants |
| Vibex MTX 15 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Written instructions were clear & easy to follow % | 100 Percentage of Participants |
| Vibex MTX 15 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Understood the written instructions (%) | 100 Percentage of Participants |
| Vibex MTX 15 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Training Confirmation Questions answered right (%) | 93.3 Percentage of Participants |
| Vibex MTX 15 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Understood the training provided by site staff (%) | 100 Percentage of Participants |
| Vibex MTX 20 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Training Confirmation Questions answered right (%) | 96.8 Percentage of Participants |
| Vibex MTX 20 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Training by site staff-clear & easy to follow (%) | 100 Percentage of Participants |
| Vibex MTX 20 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Device was easy to use (%) | 97 Percentage of Participants |
| Vibex MTX 20 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Understood the training provided by site staff (%) | 100 Percentage of Participants |
| Vibex MTX 20 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Written instructions were clear & easy to follow % | 100 Percentage of Participants |
| Vibex MTX 20 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Understood the written instructions (%) | 100 Percentage of Participants |
| Vibex MTX 25 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Training by site staff-clear & easy to follow (%) | 100 Percentage of Participants |
| Vibex MTX 25 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Understood the written instructions (%) | 100 Percentage of Participants |
| Vibex MTX 25 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Training Confirmation Questions answered right (%) | 95.0 Percentage of Participants |
| Vibex MTX 25 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Written instructions were clear & easy to follow % | 100 Percentage of Participants |
| Vibex MTX 25 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Understood the training provided by site staff (%) | 100 Percentage of Participants |
| Vibex MTX 25 mg | Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools | Device was easy to use (%) | 100 Percentage of Participants |
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: * Erythema - 0 = None * Erythema - 1 = Very slight, barely perceptible * Erythema - 2 = Obvious, but well defined * Erythema - 3 = Moderate to severe * Erythema - 4 = Severe
Time frame: 24 hours
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vibex MTX 10 mg | Safety of Vibex MTX Device | No Erythema at all post-dose time points (%) | 95 Percentage of Participants |
| Vibex MTX 10 mg | Safety of Vibex MTX Device | Erythema very slight - barely perceptible (%) | 5 Percentage of Participants |
| Vibex MTX 15 mg | Safety of Vibex MTX Device | Erythema very slight - barely perceptible (%) | 11.7 Percentage of Participants |
| Vibex MTX 15 mg | Safety of Vibex MTX Device | No Erythema at all post-dose time points (%) | 88.3 Percentage of Participants |
| Vibex MTX 20 mg | Safety of Vibex MTX Device | No Erythema at all post-dose time points (%) | 96.0 Percentage of Participants |
| Vibex MTX 20 mg | Safety of Vibex MTX Device | Erythema very slight - barely perceptible (%) | 4.0 Percentage of Participants |
| Vibex MTX 25 mg | Safety of Vibex MTX Device | No Erythema at all post-dose time points (%) | 90.0 Percentage of Participants |
| Vibex MTX 25 mg | Safety of Vibex MTX Device | Erythema very slight - barely perceptible (%) | 10.0 Percentage of Participants |
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.
Time frame: 24 hours
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vibex MTX 10 mg | 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) | Severity of pain immediately after self-injection | 1.0 mm | Standard Deviation 1.05 |
| Vibex MTX 10 mg | 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) | Severity of pain at 24 hours after self-injection | 1.7 mm | Standard Deviation 4.48 |
| Vibex MTX 15 mg | 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) | Severity of pain at 24 hours after self-injection | 2.0 mm | Standard Deviation 4.15 |
| Vibex MTX 15 mg | 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) | Severity of pain immediately after self-injection | 7.6 mm | Standard Deviation 15.6 |
| Vibex MTX 20 mg | 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) | Severity of pain immediately after self-injection | 2.2 mm | Standard Deviation 2.91 |
| Vibex MTX 20 mg | 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) | Severity of pain at 24 hours after self-injection | 1.0 mm | Standard Deviation 1.6 |
| Vibex MTX 25 mg | 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) | Severity of pain immediately after self-injection | 2.4 mm | Standard Deviation 2.56 |
| Vibex MTX 25 mg | 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) | Severity of pain at 24 hours after self-injection | 1.0 mm | Standard Deviation 1.23 |