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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Psoriasis

In brief

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.

Key facts

Study ID

NCT00643526

Run by

Centocor, Inc.

People needed

68

Starts

2007-12-01

Expected to finish

2008-01-01

Last updated by the study team

2015-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Miami, Florida, United States
• Study site — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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