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: * 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
101
Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
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
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
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
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Time frame: 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.
Time frame: 24 hours