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

June 1, 2018 updated by: AbbVie (prior sponsor, Abbott)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Victorville, California, United States, 92395
        • Site Reference ID/Investigator# 27144
    • Florida
      • Tampa, Florida, United States, 33614
        • Site Reference ID/Investigator# 27153
    • New Jersey
      • Passaic, New Jersey, United States, 07055
        • Site Reference ID/Investigator# 27150
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Site Reference ID/Investigator# 27143
      • Wyomissing, Pennsylvania, United States, 19610
        • Site Reference ID/Investigator# 27145
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Site Reference ID/Investigator# 27142
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Site Reference ID/Investigator# 27151
    • Texas
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 27152
      • Houston, Texas, United States, 77074
        • Site Reference ID/Investigator# 27147
      • Tyler, Texas, United States, 75701
        • Site Reference ID/Investigator# 27155

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Current/Physiolis Syringe
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
Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
  • ABT-D2E7
  • Humira
Device: Adalimumab delivered in Physiolis syringe
Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
  • ABT-D2E7
  • Humira
Experimental: Physiolis/Current Syringe
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
Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
  • ABT-D2E7
  • Humira
Device: Adalimumab delivered in Physiolis syringe
Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
  • ABT-D2E7
  • Humira
Experimental: Current/Physiolis Autoinjector
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
Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously
Other Names:
  • ABT-D2E7
  • Humira
Device: Adalimumab delivered in Physiolis autoinjector
Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
  • ABT-D2E7
  • Humira
Experimental: Physiolis/Current Autoinjector
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
Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously
Other Names:
  • ABT-D2E7
  • Humira
Device: Adalimumab delivered in Physiolis autoinjector
Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
  • ABT-D2E7
  • Humira
Experimental: Physiolis Autoinjector at 2° to 8°C
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
Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
  • ABT-D2E7
  • Humira
Experimental: Current Autoinjector 2° to 8°C
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
Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously
Other Names:
  • ABT-D2E7
  • Humira
Experimental: Physiolis Autoinjector 20° to 27°C
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
Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
  • ABT-D2E7
  • Humira
Experimental: Current Autoinjector 20° to 27°C
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
Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously
Other Names:
  • ABT-D2E7
  • Humira

What is the study measuring?

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
Time Frame: 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.
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
Time Frame: 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).
Phase B (Week 4)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector
Time Frame: 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).
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)
Time Frame: 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).
Phase B (Week 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M12-088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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