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

Rheumatoid Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643526
• Other study ID #: CR014914
• Status: Completed
• Phase: Phase 0
• First received: February 22, 2008
• Last updated: April 9, 2015
• Start date: December 2007
• Est. completion date: January 2008

Study information

• Verified date: April 2015
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Device:
• Pre-filled Auto-injector Containing Placebo
Participants will self-inject placebo subcutaneously at thigh and abdomen.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centocor, Inc.	Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	•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	No