Trial Outcomes & Findings for Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device (NCT NCT01618955)

Last Updated: 2014-04-30

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

101 participants

Primary outcome timeframe

24 hours

Results posted on

2014-04-30

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	MTX 10 mg Self-administration of Subcutaneous Methotrexate using VIBEX MTX	MTX 15 mg Self-administration of Subcutaneous Methotrexate using VIBEX MTX	MTX 20 mg Self-administration of Subcutaneous Methotrexate using VIBEX MTX	MTX 25 mg Self-administration of Subcutaneous Methotrexate using VIBEX MTX
Overall Study STARTED	20	30	31	20
Overall Study COMPLETED	20	30	31	20
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MTX 10 mg n=20 Participants Self-administration of Subcutaneous Methotrexate using VIBEX MTX	MTX 15 mg n=30 Participants Self-administration of Subcutaneous Methotrexate using VIBEX MTX	MTX 20 mg n=31 Participants Self-administration of Subcutaneous Methotrexate using VIBEX MTX	MTX 25 mg n=20 Participants Self-administration of Subcutaneous Methotrexate using VIBEX MTX	Total n=101 Participants Total of all reporting groups
Age, Continuous	63.5 years STANDARD_DEVIATION 11.46 • n=5 Participants	61.8 years STANDARD_DEVIATION 9.00 • n=7 Participants	59.5 years STANDARD_DEVIATION 10.46 • n=5 Participants	59.1 years STANDARD_DEVIATION 9.92 • n=4 Participants	60.9 years STANDARD_DEVIATION 10.14 • n=21 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	26 Participants n=5 Participants	16 Participants n=4 Participants	80 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	10 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	21 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	29 Participants n=7 Participants	27 Participants n=5 Participants	19 Participants n=4 Participants	93 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	29 Participants n=7 Participants	30 Participants n=5 Participants	20 Participants n=4 Participants	98 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	20 participants n=5 Participants	30 participants n=7 Participants	31 participants n=5 Participants	20 participants n=4 Participants	101 participants n=21 Participants
BMI	31.4 kg/m^2 STANDARD_DEVIATION 7.54 • n=5 Participants	31.3 kg/m^2 STANDARD_DEVIATION 7.26 • n=7 Participants	30.5 kg/m^2 STANDARD_DEVIATION 6.46 • n=5 Participants	30.3 kg/m^2 STANDARD_DEVIATION 5.28 • n=4 Participants	30.9 kg/m^2 STANDARD_DEVIATION 6.64 • n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibex MTX 10 mg n=20 Participants Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 15 mg n=30 Participants Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 20 mg n=31 Participants Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 25 mg n=20 Participants Self-administration of subcutaneous methotrexate using Vibex MTX
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibex MTX 10 mg n=20 Participants Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 15 mg n=30 Participants Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 20 mg n=31 Participants Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 25 mg n=20 Participants Self-administration of subcutaneous methotrexate using Vibex MTX
Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools Device was easy to use (%)	95 Percentage of Participants	100 Percentage of Participants	97 Percentage of Participants	100 Percentage of Participants
Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools Understood the written instructions (%)	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
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	100 Percentage of Participants	100 Percentage of Participants	100 Percentage of Participants
Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools Training Confirmation Questions answered right (%)	90 Percentage of Participants	93.3 Percentage of Participants	96.8 Percentage of Participants	95.0 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Vibex MTX 10 mg n=20 Participants Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 15 mg n=20 Participants Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 20 mg n=31 Participants Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 25 mg n=20 Participants Self-administration of subcutaneous methotrexate using Vibex MTX
Safety of Vibex MTX Device No Erythema at all post-dose time points (%)	95 Percentage of Participants	88.3 Percentage of Participants	96.0 Percentage of Participants	90.0 Percentage of Participants
Safety of Vibex MTX Device Erythema very slight - barely perceptible (%)	5 Percentage of Participants	11.7 Percentage of Participants	4.0 Percentage of Participants	10.0 Percentage of Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vibex MTX 10 mg n=20 Participants Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 15 mg n=30 Participants Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 20 mg n=31 Participants Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 25 mg n=20 Participants Self-administration of subcutaneous methotrexate using Vibex MTX
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	7.6 mm Standard Deviation 15.60	2.2 mm Standard Deviation 2.91	2.4 mm Standard Deviation 2.56
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	2.0 mm Standard Deviation 4.15	1.0 mm Standard Deviation 1.60	1.0 mm Standard Deviation 1.23

Adverse Events

Vibex MTX 10 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vibex MTX 15 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vibex MTX 20 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Vibex MTX 25 mg

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Vibex MTX 10 mg n=20 participants at risk Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 15 mg n=30 participants at risk Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 20 mg n=31 participants at risk Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 25 mg n=20 participants at risk Self-administration of subcutaneous methotrexate using Vibex MTX
Cardiac disorders Sick Sinus Syndrome	0.00% 0/20 • 1 week	0.00% 0/30 • 1 week	0.00% 0/31 • 1 week	5.0% 1/20 • Number of events 1 • 1 week

Other adverse events

Other adverse events
Measure	Vibex MTX 10 mg n=20 participants at risk Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 15 mg n=30 participants at risk Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 20 mg n=31 participants at risk Self-administration of subcutaneous methotrexate using Vibex MTX	Vibex MTX 25 mg n=20 participants at risk Self-administration of subcutaneous methotrexate using Vibex MTX
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/20 • 1 week	0.00% 0/30 • 1 week	3.2% 1/31 • Number of events 1 • 1 week	0.00% 0/20 • 1 week
Nervous system disorders Headache	0.00% 0/20 • 1 week	0.00% 0/30 • 1 week	3.2% 1/31 • Number of events 1 • 1 week	0.00% 0/20 • 1 week

Additional Information

Jonathan Jaffe, MD; Vice President-Clinical Development

Antares Pharma Inc.

Phone: 609-359-3020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60