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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Psoriasis

Intervention / Treatment
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* Device: Pre-filled Auto-injector Containing Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection Site: First Thigh Then Abdomen<br>Participants will self inject subcutaneously placebo using auto injector at thigh followed by self injection of placebo subcutaneously at abdomen on Day 1. | Device: Pre-filled Auto-injector Containing Placebo<br>* Participants will self-inject placebo subcutaneously at thigh and abdomen.<br>|
| Experimental: Injection Site: First Abdomen then Thigh<br>Participants will self inject subcutaneously placebo using auto injector at abdomen followed by self injection of placebo subcutaneously at thigh on Day 1. | Device: Pre-filled Auto-injector Containing Placebo<br>* Participants will self-inject placebo subcutaneously at thigh and abdomen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Psoriasis, Autoinjector