Status:
COMPLETED
A Study to Test the Design, Functionality, and Ergonomic Features of the Autoinjector
Lead Sponsor:
Centocor, Inc.
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Rheumatoid Arthritis
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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...
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 tri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00643526
Start Date
December 1 2007
End Date
January 1 2008
Last Update
April 10 2015
Active Locations (2)
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1
Miami, Florida, United States
2
Duncansville, Pennsylvania, United States