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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Phase 2, Multi-Center, Open-Label, Single-Dose, Single Arm, In-Clinic Study to Evaluate the Actual Human Use of Methotrexate Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device in Adult Patients With Rheumatoid Arthritis.

Conditions
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Rheumatoid Arthritis (RA)

Intervention / Treatment
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* Device: VIBEX MTX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VIBEX MTX<br>VIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status | Device: VIBEX MTX<br>* Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device<br>* Other names: prefilled autoinjector device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: SC self-injection was administered by the patient SC self-injection was intentional self-injection was administered in an appropriate location on the abdomen patient removed cap marked 1 patient removed cap marked 2 patient held device at injection site for 3 seconds patient confirmed that the window was obstructed | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 Ease of use Questionnaire was completed by patients immediately after self-injection Training confirmation questionnaire was completed by patients after the training and then reviewed with PI or site coordinator | 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: Erythema - 0 = None Erythema - 1 = Very slight, barely perceptible Erythema - 2 = Obvious, but well defined Erythema - 3 = Moderate to severe Erythema - 4 = Severe | 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 |