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

Study Overview
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Brief Summary
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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.

Detailed Description
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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-period, cross-over phase in which single subcutaneous (SC) dose injections were administered using either the Physiolis autoinjector and current autoinjector or the Physiolis syringe and current syringe in a 1:1 ratio. Phase B (Injection Time) was a randomized, single-visit, parallel-arm phase, with injection into a test tube, and one SC injection given to participants using the Physiolis autoinjector or current autoinjector administered at 2 different temperature ranges (2° to 8°C [storage temperature] and 20° to 27°C [room temperature]). If a participant only completed Visit 1 and Visit 2, then the participant was to be replaced for Visit 3. If the participant only completed Visit 1, the participant was to be replaced for all study visits.

Official Title
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A Multicenter, Randomized, Open-Label Study of the Injection Time and Usability of the Physiolis Syringe and Autoinjector in Injection-Experienced Rheumatoid Arthritis Patients

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Device: Adalimumab delivered in current syringe
* Device: Adalimumab delivered in Physiolis syringe
* Device: Adalimumab delivered in current autoinjector
* Device: Adalimumab delivered in Physiolis autoinjector


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Current/Physiolis Syringe<br>Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A) | Device: Adalimumab delivered in current syringe<br>* Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously<br>* Other names: Humira;Device: Adalimumab delivered in Physiolis syringe<br>* Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously<br>* Other names: Humira;|
| Experimental: Physiolis/Current Syringe<br>Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A) | Device: Adalimumab delivered in current syringe<br>* Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously<br>* Other names: Humira;Device: Adalimumab delivered in Physiolis syringe<br>* Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously<br>* Other names: Humira;|
| Experimental: Current/Physiolis Autoinjector<br>Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A) | Device: Adalimumab delivered in current autoinjector<br>* Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously<br>* Other names: Humira;Device: Adalimumab delivered in Physiolis autoinjector<br>* Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously<br>* Other names: Humira;|
| Experimental: Physiolis/Current Autoinjector<br>Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A) | Device: Adalimumab delivered in current autoinjector<br>* Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously<br>* Other names: Humira;Device: Adalimumab delivered in Physiolis autoinjector<br>* Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously<br>* Other names: Humira;|
| Experimental: Physiolis Autoinjector at 2° to 8°C<br>Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B) | Device: Adalimumab delivered in Physiolis autoinjector<br>* Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously<br>* Other names: Humira;|
| Experimental: Current Autoinjector 2° to 8°C<br>Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B) | Device: Adalimumab delivered in current autoinjector<br>* Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously<br>* Other names: Humira;|
| Experimental: Physiolis Autoinjector 20° to 27°C<br>Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B) | Device: Adalimumab delivered in Physiolis autoinjector<br>* Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously<br>* Other names: Humira;|
| Experimental: Current Autoinjector 20° to 27°C<br>Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B) | Device: Adalimumab delivered in current autoinjector<br>* Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously<br>* Other names: Humira;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector | Participant's overall satisfaction of the injection was collected on a 10-cm visual analog scale (VAS) completed by participants immediately after self-injection. 0 = extremely unsatisfied, 10 = extremely satisfied. | Phase A (Week 0 and Week 2) | 
| 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 | A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C). | Phase B (Week 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector | A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C). | Phase B (Week 4) | 
| Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C) | A health care provider administered the injection to the participant, while another recorded the time elapsed during the injection (from the time of autoinjector activation, signaled by the audible click, until the yellow indicator stopped moving in the autoinjector view window). Injections were administered immediately following removal from the refrigerator (2° to 8°C) or after at least 30 minutes, but no more than 45 minutes, following removal from the refrigerator for the product to reach room temperature (20° to 27°C). | Phase B (Week 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid, Arthritis