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

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.

The purpose of this study is to assess the usability of the VIBEX MTX device for SC self-injection of methotrexate.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis (RA)
• Intervention / Treatment: Device: VIBEX MTX

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

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Antares Pharma Inc.
• Investigators: Principal Investigator: Alan J Kivitz, MD;CPI, Altoona Center for Clinical Research

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 4, 2012
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (Estimate): June 14, 2012

Study Record Updates

• Last Update Posted (Estimate): April 30, 2014
• Last Update Submitted That Met QC Criteria: March 31, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: MTX-11-002