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

Early Phase 1

Completed

• Conditions: Psoriasis; Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis
• Interventions: Device: Pre-filled Auto-injector Containing Placebo

• Registration Number: NCT00643526
• Lead Sponsor: Centocor, Inc.

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-26
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection Site: First Thigh Then Abdomen	Pre-filled Auto-injector Containing Placebo	Participants will self inject subcutaneously placebo using auto injector at thigh followed by self injection of placebo subcutaneously at abdomen on Day 1.
Injection Site: First Abdomen then Thigh	Pre-filled Auto-injector Containing Placebo	Participants will self inject subcutaneously placebo using auto injector at abdomen followed by self injection of placebo subcutaneously at thigh on Day 1.

Primary Outcome Measures

Name	Time	Method
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	Day 1

Secondary Outcome Measures

Name	Time	Method
•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.	Day 1