Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid, Arthritis
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.
Interventions
DEVICEAdalimumab delivered in current syringe
Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
DEVICEAdalimumab delivered in Physiolis syringe
Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
DEVICEAdalimumab delivered in current autoinjector
Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously
DEVICEAdalimumab delivered in Physiolis autoinjector
Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Pre-assignment details
One participant withdrew after Phase A and was replaced with a new participant prior to Phase B. Participants were re-randomized for Phase B.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes participants from Phases A and B of the study | 85 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Phase A (User Experience), Weeks 0 and 2 | Didn't meet inclusion/exclusion criteria | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Phase A (User Experience), Weeks 0 and 2 | Failed to meet inclusion criteria | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase A (User Experience), Weeks 0 and 2 | Withdrew consent | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Customized <65 years | 62 participants |
| Age, Customized >=65 years | 23 participants |
| Region of Enrollment United States | 85 participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 40 | 0 / 42 | 3 / 42 | 4 / 41 | 0 / 18 | 1 / 27 | 0 / 16 | 0 / 20 |
| serious Total, serious adverse events | 0 / 40 | 0 / 42 | 0 / 42 | 0 / 41 | 0 / 18 | 0 / 27 | 0 / 16 | 0 / 20 |
Outcome results
Primary
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).
Time frame: Phase B (Week 4)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Current/Physiolis Syringe | 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 | 6.66 seconds |
| Physiolis/Current Syringe | 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 | 6.88 seconds |
Primary
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.
Time frame: Phase A (Week 0 and Week 2)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Current/Physiolis Syringe | Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector | Week 0 | 7.68 cm | Standard Deviation 2.97 |
| Current/Physiolis Syringe | Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector | Week 2 | 8.47 cm | Standard Deviation 1.92 |
| Physiolis/Current Syringe | Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector | Week 2 | 8.94 cm | Standard Deviation 1.51 |
| Physiolis/Current Syringe | Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector | Week 0 | 8.71 cm | Standard Deviation 1.57 |
| Current/Physiolis Autoinjector | Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector | Week 0 | 8.24 cm | Standard Deviation 1.82 |
| Current/Physiolis Autoinjector | Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector | Week 2 | 7.63 cm | Standard Deviation 2.86 |
| Physiolis/Current Autoinjector | Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector | Week 0 | 8.62 cm | Standard Deviation 1.71 |
| Physiolis/Current Autoinjector | Participants' Overall Satisfaction With the Drug Administration Experience Using the Physiolis Syringe/Autoinjector in Comparison to the Current Syringe/Autoinjector | Week 2 | 7.55 cm | Standard Deviation 2.71 |
Secondary
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).
Time frame: Phase B (Week 4)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Current/Physiolis Syringe | Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector | 6.88 seconds |
| Physiolis/Current Syringe | Injection Duration for the Current Autoinjector Compared to the Physiolis Autoinjector | 6.78 seconds |
Secondary
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).
Time frame: Phase B (Week 4)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Current/Physiolis Syringe | Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C) | 6.32 seconds |
| Physiolis/Current Syringe | Injection Duration for the Current Autoinjector When Administered at Room Temperature (20° to 27°C) Versus the Storage Temperature (2° to 8°C) | 7.29 seconds |