The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| 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:
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: 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) |
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:
|
Outcome Measures
Primary Outcome Measures
- Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector [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 [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).
Secondary Outcome Measures
- Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector [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) [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).
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site Reference ID/Investigator# 27144 | Victorville | California | United States | 92395 |
| 2 | Site Reference ID/Investigator# 27153 | Tampa | Florida | United States | 33614 |
| 3 | Site Reference ID/Investigator# 27150 | Passaic | New Jersey | United States | 07055 |
| 4 | Site Reference ID/Investigator# 27143 | Duncansville | Pennsylvania | United States | 16635 |
| 5 | Site Reference ID/Investigator# 27145 | Wyomissing | Pennsylvania | United States | 19610 |
| 6 | Site Reference ID/Investigator# 27142 | Charleston | South Carolina | United States | 29406 |
| 7 | Site Reference ID/Investigator# 27151 | Jackson | Tennessee | United States | 38305 |
| 8 | Site Reference ID/Investigator# 27152 | Dallas | Texas | United States | 75231 |
| 9 | Site Reference ID/Investigator# 27147 | Houston | Texas | United States | 77074 |
| 10 | Site Reference ID/Investigator# 27155 | Tyler | Texas | United States | 75701 |
Sponsors and Collaborators
- AbbVie (prior sponsor, Abbott)
Investigators
- Study Director: Andrew Payne, PhD, AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- M12-088
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | One participant withdrew after Phase A and was replaced with a new participant prior to Phase B. Participants were re-randomized for Phase B. |
| Arm/Group Title | Current Syringe First, Then Physiolis Syringe | Physiolis Syringe First, Then Current Syringe | Current Autoinjector First, Then Physiolis Autoinjector | Physiolis Autoinjector First, Then 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/Group 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) |
| Period Title: Phase A (User Experience), Weeks 0 and 2 | ||||||||
| STARTED | 19 | 23 | 21 | 21 | 0 | 0 | 0 | 0 |
| COMPLETED | 19 | 21 | 20 | 21 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Phase A (User Experience), Weeks 0 and 2 | ||||||||
| STARTED | 0 | 0 | 0 | 0 | 18 | 27 | 16 | 20 |
| COMPLETED | 0 | 0 | 0 | 0 | 18 | 27 | 16 | 20 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | All Study Participants |
|---|---|
| Arm/Group Description | Includes participants from Phases A and B of the study |
| Overall Participants | 85 |
| Age, Customized (participants) [Number] | |
| <65 years |
62
72.9%
|
| >=65 years |
23
27.1%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
68
80%
|
| Male |
17
20%
|
| Region of Enrollment (participants) [Number] | |
| United States |
85
100%
|
Outcome Measures
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Current/Physiolis Syringe | Physiolis/Current Syringe | Current/Physiolis Autoinjector | Physiolis/Current Autoinjector |
|---|---|---|---|---|
| Arm/Group Description | Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) | Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) | Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) | Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) |
| Measure Participants | 19 | 23 | 21 | 21 |
| Week 0 |
7.68
(2.97)
|
8.71
(1.57)
|
8.24
(1.82)
|
8.62
(1.71)
|
| Week 2 |
8.47
(1.92)
|
8.94
(1.51)
|
7.63
(2.86)
|
7.55
(2.71)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Physiolis Autoinjector 20° to 27°C | Physiolis Autoinjector at 2° to 8°C |
|---|---|---|
| Arm/Group Description | Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) | Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) |
| Measure Participants | 16 | 18 |
| Mean (90% Confidence Interval) [seconds] |
6.66
|
6.88
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Current Autoinjector | Physiolis Autoinjector |
|---|---|---|
| Arm/Group Description | Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) and room temperature (20° to 27°C) | Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) and room temperature (20° to 27°C) |
| Measure Participants | 47 | 34 |
| Mean (90% Confidence Interval) [seconds] |
6.88
|
6.78
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Current Autoinjector 20° to 27°C | Current Autoinjector 2° to 8°C |
|---|---|---|
| Arm/Group Description | Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) | Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) |
| Measure Participants | 20 | 27 |
| Mean (90% Confidence Interval) [seconds] |
6.32
|
7.29
|
Adverse Events
| Time Frame | Adverse events were collected from the time of study drug administration until 70 days following the last treatment. Serious adverse events were collected from the time the participant signed the informed consent. | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Those participants that continued on adalimumab therapy after the end of the study were not required to complete the 70-day follow-up. | |||||||||||||||
| Arm/Group Title | Current Syringe | Physiolis Syringe | Current Autoinjector | Physiolis 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/Group Description | Self-injection using current syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A) | Self-injection using Physiolis syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A) | Self-injection using current autoinjector at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A) | Self-injection using Physiolis autoinjector at Week 0 or 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) | ||||||||
All Cause Mortality |
||||||||||||||||
| Current Syringe | Physiolis Syringe | Current Autoinjector | Physiolis 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 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Current Syringe | Physiolis Syringe | Current Autoinjector | Physiolis 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 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/40 (0%) | 0/42 (0%) | 0/42 (0%) | 0/41 (0%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Current Syringe | Physiolis Syringe | Current Autoinjector | Physiolis 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 | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/40 (7.5%) | 0/42 (0%) | 3/42 (7.1%) | 4/41 (9.8%) | 0/18 (0%) | 1/27 (3.7%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Abdominal pain | 0/40 (0%) | 0/42 (0%) | 1/42 (2.4%) | 0/41 (0%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| General disorders | ||||||||||||||||
| Injection site reaction | 0/40 (0%) | 0/42 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Odema | 1/40 (2.5%) | 0/42 (0%) | 0/42 (0%) | 0/41 (0%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Odema peripheral | 1/40 (2.5%) | 0/42 (0%) | 0/42 (0%) | 0/41 (0%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Swelling | 1/40 (2.5%) | 0/42 (0%) | 0/42 (0%) | 0/41 (0%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Sinusitis | 1/40 (2.5%) | 0/42 (0%) | 0/42 (0%) | 0/41 (0%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Arthropod bite | 0/40 (0%) | 0/42 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Investigations | ||||||||||||||||
| Vitamin D decreased | 0/40 (0%) | 0/42 (0%) | 1/42 (2.4%) | 0/41 (0%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Back pain | 0/40 (0%) | 0/42 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Bursitis | 0/40 (0%) | 0/42 (0%) | 1/42 (2.4%) | 0/41 (0%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Pain in extremity | 0/40 (0%) | 0/42 (0%) | 0/42 (0%) | 0/41 (0%) | 0/18 (0%) | 1/27 (3.7%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Hypoaesthesia | 0/40 (0%) | 0/42 (0%) | 0/42 (0%) | 0/41 (0%) | 0/18 (0%) | 1/27 (3.7%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Erythema | 0/40 (0%) | 0/42 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Pruritis | 0/40 (0%) | 0/42 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
| Psoriasis | 0/40 (0%) | 0/42 (0%) | 0/42 (0%) | 1/41 (2.4%) | 0/18 (0%) | 0/27 (0%) | 0/16 (0%) | 0/20 (0%) | ||||||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie (prior sponsor, Abbott) |
| Phone | 800-633-9110 |
- M12-088