Clinical trial NCT01163617: The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients
Official title: A Multicenter, Randomized, Open-Label Study of the Injection Time and Usability of the Physiolis Syringe and Autoinjector in Injection-Experienced Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid
Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-07-16
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector
timeFrame: Phase A (Week 0 and Week 2)
measure: 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
timeFrame: Phase B (Week 4)
Secondary outcomes:
measure: Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector
timeFrame: Phase B (Week 4)
measure: Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C)
timeFrame: Phase B (Week 4)
Other outcomes:
Locations:
city: Victorville
country: United States
facility: Site Reference ID/Investigator# 27144
state: California
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 27153
state: Florida
city: Passaic
country: United States
facility: Site Reference ID/Investigator# 27150
state: New Jersey
city: Duncansville
country: United States
facility: Site Reference ID/Investigator# 27143
state: Pennsylvania
city: Wyomissing
country: United States
facility: Site Reference ID/Investigator# 27145
state: Pennsylvania
city: Charleston
country: United States
facility: Site Reference ID/Investigator# 27142
state: South Carolina
city: Jackson
country: United States
facility: Site Reference ID/Investigator# 27151
state: Tennessee
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 27152
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 27147
state: Texas
city: Tyler
country: United States
facility: Site Reference ID/Investigator# 27155
state: Texas
Study officials:
affiliation: AbbVie
name: Andrew Payne, PhD
role: STUDY_DIRECTOR
References:
citation: Li Z, Easton R. Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics. MAbs. 2018 Jan;10(1):18-33. doi: 10.1080/19420862.2017.1392424. Epub 2017 Nov 7.