The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients

Completed · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

This was an open-label, Phase 2 study designed to obtain user experience data (Phase A) and injection time data (Phase B) in experienced adalimumab patients injected with the Physiolis pre-filled syringe and autoinjector used to administer adalimumab.

Key facts

Study ID

NCT01163617

Run by

AbbVie (prior sponsor, Abbott)

People needed

85

Starts

2010-05-01

Expected to finish

2010-11-01

Last updated by the study team

2018-07-02

Who can join

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

You may qualify if…

• Subject was judged to be in good health as determined by the investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray, and a 12-lead electrocardiogram performed during Screening.
• Subject had a negative purified protein derivative (PPD) test (or equivalent) and chest x-ray (posterior-anterior and lateral view) at Screening.
• Subject has a diagnosis of moderate to severe rheumatoid arthritis and is treated with adalimumab in accordance with the FDA-approved Humira prescribing information.
• Subject must have self-administered adalimumab subcutaneous (SC) 40 mg injections every other week (eow) without interruption for at least 3 months prior to Screening.
• For the Phase A portion of the study, the subject must be able and willing to self administer SC injections in the thigh or abdomen (administration by another person was not permissible).

You may not qualify if…

• Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to the Visit 1, with the exception of adalimumab.
• Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Visit 1 or oral anti-infectives within 14 days prior to Visit 1.
• Prior exposure to natalizumab (Tysabri®) or efalizumab (Raptiva®).
• Known hypersensitivity to adalimumab or its excipients.
• Regular use of any SC medications, with the exception of adalimumab.

Where it is running

• Site Reference ID/Investigator# 27144 — Victorville, California, United States
• Site Reference ID/Investigator# 27153 — Tampa, Florida, United States
• Site Reference ID/Investigator# 27150 — Passaic, New Jersey, United States
• Site Reference ID/Investigator# 27143 — Duncansville, Pennsylvania, United States
• Site Reference ID/Investigator# 27145 — Wyomissing, Pennsylvania, United States
• Site Reference ID/Investigator# 27142 — Charleston, South Carolina, United States
• Site Reference ID/Investigator# 27151 — Jackson, Tennessee, United States
• Site Reference ID/Investigator# 27152 — Dallas, Texas, United States
• Site Reference ID/Investigator# 27147 — Houston, Texas, United States
• Site Reference ID/Investigator# 27155 — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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