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

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Device: Adalimumab delivered in Physiolis autoinjector
Device: Adalimumab delivered in current autoinjector
Device: Adalimumab delivered in current syringe
Device: Adalimumab delivered in Physiolis syringe

Registration Number: NCT01163617

Lead Sponsor: AbbVie (prior sponsor, Abbott)

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 syringe and autoinjector used to administer adalimumab.

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-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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 85

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Physiolis Autoinjector at 2° to 8°C	Adalimumab delivered in Physiolis autoinjector	Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
Current Autoinjector 2° to 8°C	Adalimumab delivered in current autoinjector	Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
Physiolis/Current Autoinjector	Adalimumab delivered in current autoinjector	Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
Physiolis Autoinjector 20° to 27°C	Adalimumab delivered in Physiolis autoinjector	Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
Physiolis/Current Syringe	Adalimumab delivered in current syringe	Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
Current Autoinjector 20° to 27°C	Adalimumab delivered in current autoinjector	Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
Current/Physiolis Syringe	Adalimumab delivered in current syringe	Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
Current/Physiolis Autoinjector	Adalimumab delivered in current autoinjector	Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
Current/Physiolis Autoinjector	Adalimumab delivered in Physiolis autoinjector	Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
Physiolis/Current Autoinjector	Adalimumab delivered in Physiolis autoinjector	Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
Current/Physiolis Syringe	Adalimumab delivered in Physiolis syringe	Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
Physiolis/Current Syringe	Adalimumab delivered in Physiolis syringe	Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)

Primary Outcome Measures

Name	Time	Method
Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector	Phase A (Week 0 and Week 2)	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.
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	Phase B (Week 4)	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).

Secondary Outcome Measures

Name	Time	Method
Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector	Phase B (Week 4)	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).
Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C)	Phase B (Week 4)	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).

Trial Locations

Locations (10): Site Reference ID/Investigator# 27144
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Victorville, California, United States
Site Reference ID/Investigator# 27153
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Tampa, Florida, United States
Site Reference ID/Investigator# 27143
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Duncansville, Pennsylvania, United States
Site Reference ID/Investigator# 27145
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Wyomissing, Pennsylvania, United States
Site Reference ID/Investigator# 27142
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Charleston, South Carolina, United States
Site Reference ID/Investigator# 27147
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Houston, Texas, United States
Site Reference ID/Investigator# 27152
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Dallas, Texas, United States
Site Reference ID/Investigator# 27155
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Tyler, Texas, United States
Site Reference ID/Investigator# 27151
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Jackson, Tennessee, United States
Site Reference ID/Investigator# 27150
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Passaic, New Jersey, United States