Status:
COMPLETED
The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 syri...
Detailed Description
This was a Phase 2, open-label study consisting of 2 study phases with a total of 3 study visits, each visit occurring 2 weeks apart from each other. Phase A (User Experience) was a randomized, 2-peri...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01163617
Start Date
May 1 2010
End Date
November 1 2010
Last Update
July 2 2018
Active Locations (10)
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1
Site Reference ID/Investigator# 27144
Victorville, California, United States, 92395
2
Site Reference ID/Investigator# 27153
Tampa, Florida, United States, 33614
3
Site Reference ID/Investigator# 27150
Passaic, New Jersey, United States, 07055
4
Site Reference ID/Investigator# 27143
Duncansville, Pennsylvania, United States, 16635