Phase 2
Completed N=84
The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients
Source: ClinicalTrials.gov NCT01163617 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector — 7.68; 8.71; 8.24; 8.62 cm
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 syringe and autoinjector used to administer adalimumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector |
7.68; 8.71; 8.24; 8.62; 8.47; 8.94 | — |
| PRIMARY Injection Duration for the Physiolis Autoinjector at Room Temperature (20° to 27°C) and at Storage Temperature (2° to 8°C) Compared to the Current Autoinjector Ejection Time Specification of Not More Than 10 Seconds |
6.66; 6.88 | — |
| SECONDARY Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector |
6.88; 6.78 | — |
| SECONDARY Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C) |
6.32; 7.29 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01163617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.