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

NCT ID: NCT01163617

Last Updated: 2018-07-02

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Adalimumab delivered in current syringe

Intervention Type DEVICE

Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

Adalimumab delivered in Physiolis syringe

Intervention Type DEVICE

Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

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)

Group Type EXPERIMENTAL

Adalimumab delivered in current syringe

Intervention Type DEVICE

Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

Adalimumab delivered in Physiolis syringe

Intervention Type DEVICE

Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

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)

Group Type EXPERIMENTAL

Adalimumab delivered in current autoinjector

Intervention Type DEVICE

Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously

Adalimumab delivered in Physiolis autoinjector

Intervention Type DEVICE

Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

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)

Group Type EXPERIMENTAL

Adalimumab delivered in current autoinjector

Intervention Type DEVICE

Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously

Adalimumab delivered in Physiolis autoinjector

Intervention Type DEVICE

Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

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)

Group Type EXPERIMENTAL

Adalimumab delivered in Physiolis autoinjector

Intervention Type DEVICE

Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

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)

Group Type EXPERIMENTAL

Adalimumab delivered in current autoinjector

Intervention Type DEVICE

Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously

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)

Group Type EXPERIMENTAL

Adalimumab delivered in Physiolis autoinjector

Intervention Type DEVICE

Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

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)

Group Type EXPERIMENTAL

Adalimumab delivered in current autoinjector

Intervention Type DEVICE

Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously

Interventions

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Adalimumab delivered in current syringe

Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

Intervention Type DEVICE

Adalimumab delivered in Physiolis syringe

Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

Intervention Type DEVICE

Adalimumab delivered in current autoinjector

Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously

Intervention Type DEVICE

Adalimumab delivered in Physiolis autoinjector

Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously

Intervention Type DEVICE

Other Intervention Names

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ABT-D2E7 Humira ABT-D2E7 Humira ABT-D2E7 Humira ABT-D2E7 Humira

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Payne, PhD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 27144

Victorville, California, United States

Site Status

Site Reference ID/Investigator# 27153

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 27150

Passaic, New Jersey, United States

Site Status

Site Reference ID/Investigator# 27143

Duncansville, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 27145

Wyomissing, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 27142

Charleston, South Carolina, United States

Site Status

Site Reference ID/Investigator# 27151

Jackson, Tennessee, United States

Site Status

Site Reference ID/Investigator# 27152

Dallas, Texas, United States

Site Status

Site Reference ID/Investigator# 27147

Houston, Texas, United States

Site Status

Site Reference ID/Investigator# 27155

Tyler, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29035675 (View on PubMed)

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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M12-088

Identifier Type: -

Identifier Source: org_study_id

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