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

Phase 2

Completed

Conditions: Rheumatoid Arthritis (RA)

Interventions: Device: VIBEX MTX

Registration Number: NCT01618955

Lead Sponsor: Antares Pharma Inc.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VIBEX MTX	VIBEX MTX	VIBEX MTX dose based on the subject's current therapeutic regimen of MTX and rheumatoid arthritis disease status

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.