Back to resultsThe Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adalimumab delivered in current syringe
Adalimumab delivered in Physiolis syringe
Adalimumab delivered in current autoinjector
Adalimumab delivered in Physiolis autoinjector
Sponsored by
About this trial
This is an interventional other trial for Rheumatoid Arthritis focused on measuring Rheumatoid, Arthritis
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.
Sites / Locations
- Site Reference ID/Investigator# 27144
- Site Reference ID/Investigator# 27153
- Site Reference ID/Investigator# 27150
- Site Reference ID/Investigator# 27143
- Site Reference ID/Investigator# 27145
- Site Reference ID/Investigator# 27142
- Site Reference ID/Investigator# 27151
- Site Reference ID/Investigator# 27152
- Site Reference ID/Investigator# 27147
- Site Reference ID/Investigator# 27155
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Current/Physiolis Syringe
Physiolis/Current Syringe
Current/Physiolis Autoinjector
Physiolis/Current Autoinjector
Physiolis Autoinjector at 2° to 8°C
Current Autoinjector 2° to 8°C
Physiolis Autoinjector 20° to 27°C
Current Autoinjector 20° to 27°C
Arm Description
Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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).
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).
Full Information
NCT ID
NCT01163617
First Posted
May 4, 2010
Last Updated
June 1, 2018
Sponsor
AbbVie (prior sponsor, Abbott)
1. Study Identification
Unique Protocol Identification Number
NCT01163617
Brief Title
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
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid, Arthritis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Current/Physiolis Syringe
Arm Type
Experimental
Arm Description
Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
Arm Title
Physiolis/Current Syringe
Arm Type
Experimental
Arm Description
Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
Arm Title
Current/Physiolis Autoinjector
Arm Type
Experimental
Arm Description
Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
Arm Title
Physiolis/Current Autoinjector
Arm Type
Experimental
Arm Description
Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
Arm Title
Physiolis Autoinjector at 2° to 8°C
Arm Type
Experimental
Arm Description
Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
Arm Title
Current Autoinjector 2° to 8°C
Arm Type
Experimental
Arm Description
Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
Arm Title
Physiolis Autoinjector 20° to 27°C
Arm Type
Experimental
Arm Description
Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
Arm Title
Current Autoinjector 20° to 27°C
Arm Type
Experimental
Arm Description
Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
Intervention Type
Device
Intervention Name(s)
Adalimumab delivered in current syringe
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Intervention Type
Device
Intervention Name(s)
Adalimumab delivered in Physiolis syringe
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Intervention Type
Device
Intervention Name(s)
Adalimumab delivered in current autoinjector
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously
Intervention Type
Device
Intervention Name(s)
Adalimumab delivered in Physiolis autoinjector
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Primary Outcome Measure Information:
Title
Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector
Description
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.
Time Frame
Phase A (Week 0 and Week 2)
Title
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
Description
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).
Time Frame
Phase B (Week 4)
Secondary Outcome Measure Information:
Title
Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector
Description
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).
Time Frame
Phase B (Week 4)
Title
Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C)
Description
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).
Time Frame
Phase B (Week 4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Payne, PhD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 27144
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Facility Name
Site Reference ID/Investigator# 27153
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Site Reference ID/Investigator# 27150
City
Passaic
State/Province
New Jersey
ZIP/Postal Code
07055
Country
United States
Facility Name
Site Reference ID/Investigator# 27143
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Site Reference ID/Investigator# 27145
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Site Reference ID/Investigator# 27142
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Site Reference ID/Investigator# 27151
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Site Reference ID/Investigator# 27152
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site Reference ID/Investigator# 27147
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Site Reference ID/Investigator# 27155
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29035675
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.
Results Reference
background
Links:
URL
http://rxabbvie.com
Description
Related Info
Learn more about this trial
The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients
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