The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients
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ClinicalTrials.gov Identifier: NCT01163617 |
Recruitment Status :
Completed
First Posted : July 16, 2010
Results First Posted : March 10, 2014
Last Update Posted : July 2, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Device: Adalimumab delivered in current syringe Device: Adalimumab delivered in Physiolis syringe Device: Adalimumab delivered in current autoinjector Device: Adalimumab delivered in Physiolis autoinjector | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 85 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
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 Start Date : | May 2010 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |

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)
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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:
Device: Adalimumab delivered in Physiolis syringe Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
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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:
Device: Adalimumab delivered in Physiolis syringe Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
|
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:
Device: Adalimumab delivered in Physiolis autoinjector Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
|
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:
Device: Adalimumab delivered in Physiolis autoinjector Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
|
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)
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Device: Adalimumab delivered in Physiolis autoinjector
Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Other Names:
|
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:
|
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:
|
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:
|
- 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.
- 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).
- 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).
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163617
United States, California | |
Site Reference ID/Investigator# 27144 | |
Victorville, California, United States, 92395 | |
United States, Florida | |
Site Reference ID/Investigator# 27153 | |
Tampa, Florida, United States, 33614 | |
United States, New Jersey | |
Site Reference ID/Investigator# 27150 | |
Passaic, New Jersey, United States, 07055 | |
United States, Pennsylvania | |
Site Reference ID/Investigator# 27143 | |
Duncansville, Pennsylvania, United States, 16635 | |
Site Reference ID/Investigator# 27145 | |
Wyomissing, Pennsylvania, United States, 19610 | |
United States, South Carolina | |
Site Reference ID/Investigator# 27142 | |
Charleston, South Carolina, United States, 29406 | |
United States, Tennessee | |
Site Reference ID/Investigator# 27151 | |
Jackson, Tennessee, United States, 38305 | |
United States, Texas | |
Site Reference ID/Investigator# 27152 | |
Dallas, Texas, United States, 75231 | |
Site Reference ID/Investigator# 27147 | |
Houston, Texas, United States, 77074 | |
Site Reference ID/Investigator# 27155 | |
Tyler, Texas, United States, 75701 |
Study Director: | Andrew Payne, PhD | AbbVie |
Additional Information:
Publications:
Responsible Party: | AbbVie (prior sponsor, Abbott) |
ClinicalTrials.gov Identifier: | NCT01163617 History of Changes |
Other Study ID Numbers: |
M12-088 |
First Posted: | July 16, 2010 Key Record Dates |
Results First Posted: | March 10, 2014 |
Last Update Posted: | July 2, 2018 |
Last Verified: | January 2014 |
Rheumatoid Arthritis |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |