Skip to main content
OpenTrials
Completed

NCT Number: NCT00643526

A Study to Test the Design, Functionality, and Ergonomic Features of the Autoinjector

The main purpose of this study is to evaluate how well the autoinjector works in a group of people who are likely to use the autoinjector for injecting their medicine in the future. However, no active medicine is given by the autoinjector.

Completed

Looking for future studies?

Notify Me

Key information

About this study

This device (called an autoinjector) automatically injects medicine under the skin with a sterile needle, and is similar to other types of autoinjectors currently being used for this purpose. This trial has been designed to make sure that people, who are likely to use this device, are able to self-inject and understand the training material. A total of 68 subjects took part in the study. About half (30 patients) will have either Rheumatoid Arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) and the other half will have psoriasis (a type of skin disease), since this device will be used by patients with one of these diseases to inject their medication. The study is designed to have each patient complete 2 self-injections with the autoinjector in 2 different sites-one in the front of the thigh and one in the abdomen 2 inches away from the navel. The order of the first injection location is decided by randomization. The patient will have an equal chance of having the thigh or the abdomen as the first injection. The study staff will assess the subject's safety prior to the patient leaving the clinic. Two prefilled, 1mL placebo autoinjectors for subcutaneous injection

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have the capacity to understand and sign an informed consent form
  • Have one of the following diagnoses: rheumatoid arthritis/psoriatic arthritis/ankylosing spondylitis, or psoriasis
  • Be willing and able to self-inject

Exclusion criteria

  • Have a recent history of (within 6 months prior to study entry) or current diagnosis of a major bleeding or coagulation disorder
  • Have a prior history of a inability to use an autoinjector
  • Have an allergy to latex or any component of the autoinjector
  • Female participants who are pregnant
  • Are unwilling to complete the study assessments

Treatment and study plan

Pre-filled Auto-injector Containing Placebo

Device

Participants will self-inject placebo subcutaneously at thigh and abdomen.

Primary outcomes

  1. To establish that the autoinjector, as designed, meets defined user needs and intended use for self administration by patients with RA, PsA, AS, and psoriasis

    Time frame: Day 1

Secondary outcomes

  1. •To establish that the specific training, including the instructional video and the Instructions for Use, are appropriate, easy to understand, and able to be followed and implemented by patients with RA, PsA, AS, and psoriasis.

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Centocor, Inc.

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

An Open-Label, Randomized, Validation Study to Establish That the Design, Functionality, and Ergonomic Features of the Autoinjector Conform to Defined User Needs and Intended Use for Self-Administration by Subjects With Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Psoriasis

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 26, 2008
Registry last updated
Apr 10, 2015

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.

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