The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients
A Multicenter, Randomized, Open-Label Study of the Injection Time and Usability of the Physiolis Syringe and Autoinjector in Injection-Experienced Rheumatoid Arthritis Patients
1 other identifier
interventional
85
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started May 2010
Shorter than P25 for phase_2 rheumatoid-arthritis
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 4, 2010
CompletedFirst Posted
Study publicly available on registry
July 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
March 10, 2014
CompletedJuly 2, 2018
January 1, 2014
6 months
May 4, 2010
November 1, 2013
June 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector
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)
Phase B (Week 4)
Study Arms (8)
Current/Physiolis Syringe
EXPERIMENTALSelf-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
Physiolis/Current Syringe
EXPERIMENTALSelf-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
Current/Physiolis Autoinjector
EXPERIMENTALSelf-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
Physiolis/Current Autoinjector
EXPERIMENTALSelf-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
Physiolis Autoinjector at 2° to 8°C
EXPERIMENTALInjection 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
EXPERIMENTALInjection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
Physiolis Autoinjector 20° to 27°C
EXPERIMENTALInjection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
Current Autoinjector 20° to 27°C
EXPERIMENTALInjection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
Interventions
Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously
Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Site Reference ID/Investigator# 27144
Victorville, California, 92395, United States
Site Reference ID/Investigator# 27153
Tampa, Florida, 33614, United States
Site Reference ID/Investigator# 27150
Passaic, New Jersey, 07055, United States
Site Reference ID/Investigator# 27143
Duncansville, Pennsylvania, 16635, United States
Site Reference ID/Investigator# 27145
Wyomissing, Pennsylvania, 19610, United States
Site Reference ID/Investigator# 27142
Charleston, South Carolina, 29406, United States
Site Reference ID/Investigator# 27151
Jackson, Tennessee, 38305, United States
Site Reference ID/Investigator# 27152
Dallas, Texas, 75231, United States
Site Reference ID/Investigator# 27147
Houston, Texas, 77074, United States
Site Reference ID/Investigator# 27155
Tyler, Texas, 75701, United States
Related Publications (1)
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.
PMID: 29035675BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie (prior sponsor, Abbott)
Study Officials
- STUDY DIRECTOR
Andrew Payne, PhD
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2010
First Posted
July 16, 2010
Study Start
May 1, 2010
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
July 2, 2018
Results First Posted
March 10, 2014
Record last verified: 2014-01