Skip to main content
OpenTrials
Completed

NCT Number: NCT01618955

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIBEX MTX

Device

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

Primary outcomes

  1. 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

    Time frame: 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:

    • 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

Secondary outcomes

  1. Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools

    Time frame: 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

    • 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

  2. Safety of Vibex MTX Device

    Time frame: 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

  3. 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Antares Pharma Inc.

Industry

Registry information

Official study title

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.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 14, 2012
Registry last updated
Apr 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.