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Trial Outcomes & Findings for Tocilizumab Real-Life Human Factors (RLHFs) Validation Study (NCT NCT02682823)

NCT ID: NCT02682823

Last Updated: 2019-04-19

Results Overview

Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention. Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use. Essential tasks included those essential to the execution of the injection. Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered. The percentage of participants who successfully performed safety-critical and essential tasks during the first unassisted use (Day 14) was reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

91 participants

Primary outcome timeframe

Day 14

Results posted on

2019-04-19

Participant Flow

Participant milestones

Participant milestones
Measure
Caregivers
Caregivers (CGs) performed injection of 162 milligrams (mg) subcutaneous (SC) tocilizumab to a subset of participants with rheumatoid arthritis (RA) using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Healthcare Professionals
Healthcare professionals (HCPs) performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 1 (Self-Administration)
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Overall Study
STARTED
17
19
19
17
19
Overall Study
Safety Population
17
19
18
17
19
Overall Study
COMPLETED
17
18
18
16
18
Overall Study
NOT COMPLETED
0
1
1
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Caregivers
Caregivers (CGs) performed injection of 162 milligrams (mg) subcutaneous (SC) tocilizumab to a subset of participants with rheumatoid arthritis (RA) using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Healthcare Professionals
Healthcare professionals (HCPs) performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 1 (Self-Administration)
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Overall Study
Withdrawal by Subject
0
0
1
0
1
Overall Study
Protocol Deviation
0
1
0
0
0
Overall Study
Adverse Event
0
0
0
1
0

Baseline Characteristics

Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Caregivers
n=17 Participants
CGs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Healthcare Professionals
n=19 Participants
HCPs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 1 (Self-Administration)
n=18 Participants
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
n=17 Participants
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
n=19 Participants
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Total
n=90 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
Age, Categorical
Between 18 and 65 years
15 Participants
n=5 Participants
17 Participants
n=7 Participants
14 Participants
n=5 Participants
15 Participants
n=4 Participants
16 Participants
n=21 Participants
77 Participants
n=10 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
2 Participants
n=4 Participants
3 Participants
n=21 Participants
13 Participants
n=10 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
17 Participants
n=7 Participants
13 Participants
n=5 Participants
13 Participants
n=4 Participants
13 Participants
n=21 Participants
68 Participants
n=10 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
4 Participants
n=4 Participants
6 Participants
n=21 Participants
22 Participants
n=10 Participants

PRIMARY outcome

Timeframe: Day 14

Population: Safety Population; only those who performed the administration task(s) on Day 14 were included because the endpoint was not applicable to non-injecting participants. Here, "n" refers to number evaluable for the specified assessment, respectively.

Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention. Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use. Essential tasks included those essential to the execution of the injection. Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered. The percentage of participants who successfully performed safety-critical and essential tasks during the first unassisted use (Day 14) was reported.

Outcome measures

Outcome measures
Measure
RA Group 1 (Self-Administration)
n=17 Participants
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Caregivers
n=17 Participants
CGs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Healthcare Professionals
n=18 Participants
HCPs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
Start injection
93.75 percentage of participants
94.12 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
Open carton, remove device/documents
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
Remove cap
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
Hold until complete dose delivered
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
Release activation button
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
Check expiry date
88.24 percentage of participants
58.82 percentage of participants
72.22 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
Inspect device prior to use
76.47 percentage of participants
47.06 percentage of participants
66.67 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
Inspect medication prior to use
82.35 percentage of participants
82.35 percentage of participants
88.89 percentage of participants
—
—

PRIMARY outcome

Timeframe: Day 28

Population: Safety Population; only those who performed the administration task(s) on Day 28 were included because the endpoint was not applicable to non-injecting participants.

Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention. Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use. Essential tasks included those essential to the execution of the injection. Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered. The percentage of participants who successfully performed safety-critical and essential tasks during the second unassisted use (Day 28) was reported.

Outcome measures

Outcome measures
Measure
RA Group 1 (Self-Administration)
n=18 Participants
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Caregivers
n=17 Participants
CGs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Healthcare Professionals
n=18 Participants
HCPs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
Inspect medication prior to use
88.89 percentage of participants
70.59 percentage of participants
94.44 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
Open carton, remove device/documents
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
Remove cap
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
Start injection
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
Hold until complete dose delivered
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
Release activation button
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
Check expiry date
94.44 percentage of participants
76.47 percentage of participants
94.44 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
Inspect device prior to use
77.78 percentage of participants
58.82 percentage of participants
83.33 percentage of participants
—
—

SECONDARY outcome

Timeframe: Days 14, 28

Population: Safety Population; only those who performed the administration task(s) were included because the endpoint was not applicable to non-injecting participants. Here, "n" refers to number evaluable for the specified assessment, respectively.

Ancillary tasks included those tasks where the potential harm resulting from use error would be minor in severity, or the resultant harms were estimated to occur at sufficiently low levels. Ancillary tasks included the following: wash hands; clean the injection site with alcohol swab; wait for the alcohol to dry; dispose of the autoinjector cap; inspect full dose delivered after use; dispose of the autoinjector; and treatment of injection site after injection. The percentage of participants who succesffully performed ancillary tasks during the first (Day 14) and second unassisted use (Day 28) was reported.

Outcome measures

Outcome measures
Measure
RA Group 1 (Self-Administration)
n=18 Participants
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Caregivers
n=17 Participants
CGs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Healthcare Professionals
n=18 Participants
HCPs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
Day (D) 14, wash hands
82.35 percentage of participants
82.35 percentage of participants
77.78 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D14, wait for alcohol to dry
94.12 percentage of participants
94.12 percentage of participants
88.89 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D28, wash hands
88.89 percentage of participants
94.12 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D14, clean/swab injection site
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D28, clean/swab injection site
94.44 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D28, wait for alcohol to dry
82.35 percentage of participants
100.00 percentage of participants
83.33 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D14, dispose of device cap
94.12 percentage of participants
86.67 percentage of participants
83.33 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D28, dispose of device cap
94.44 percentage of participants
88.24 percentage of participants
94.44 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D14, inspect full dose delivered
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D28, inspect full dose delivered
94.44 percentage of participants
94.12 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D14, dispose of device
93.33 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D28, dispose of device
94.44 percentage of participants
94.12 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D14, treatment of site post injection
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
D28, treatment of site post injection
100.00 percentage of participants
100.00 percentage of participants
100.00 percentage of participants
—
—

SECONDARY outcome

Timeframe: 0 and 15 minutes after injection on Days 0, 14, 28

Population: Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs. Here, "n" refers to number evaluable for the specified assessment, respectively.

Injection pain was assessed on a continuous 100-millimeter (mm) VAS, where 0 mm represents "no pain" and 100 mm represents "unbearable pain". The mean VAS response at each assessment timepoint was reported among participants with RA.

Outcome measures

Outcome measures
Measure
RA Group 1 (Self-Administration)
n=18 Participants
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Caregivers
n=17 Participants
CGs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Healthcare Professionals
n=19 Participants
HCPs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
D0, 0 minutes (min)
2.8 mm
Standard Deviation 4.0
9.9 mm
Standard Deviation 13.7
13.3 mm
Standard Deviation 22.9
—
—
Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
D0, 15min
1.2 mm
Standard Deviation 2.3
0.9 mm
Standard Deviation 1.9
0.8 mm
Standard Deviation 1.9
—
—
Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
D14, 0min
5.4 mm
Standard Deviation 12.9
5.0 mm
Standard Deviation 7.0
11.4 mm
Standard Deviation 17.3
—
—
Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
D14, 15min
1.5 mm
Standard Deviation 2.8
0.5 mm
Standard Deviation 0.9
0.7 mm
Standard Deviation 1.4
—
—
Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
D28, 0min
4.5 mm
Standard Deviation 5.2
5.8 mm
Standard Deviation 9.0
14.5 mm
Standard Deviation 20.1
—
—
Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
D28, 15min
0.6 mm
Standard Deviation 1.5
1.9 mm
Standard Deviation 5.7
0.7 mm
Standard Deviation 1.2
—
—

SECONDARY outcome

Timeframe: 0 and 15 minutes after injection on Days 0, 14, 28

Population: Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs. Here, "n" refers to number evaluable for the specified assessment, respectively.

Injection pain was assessed on a categorical 6-point Likert scale, ranging from "no pain" to "severe and intolerable". The percentage of participants was reported by response at each assessment timepoint among participants with RA.

Outcome measures

Outcome measures
Measure
RA Group 1 (Self-Administration)
n=18 Participants
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Caregivers
n=17 Participants
CGs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Healthcare Professionals
n=19 Participants
HCPs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D28, 15min, severe and intolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D0, 0min, no pain
66.7 percentage of participants
47.1 percentage of participants
47.4 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D0, 0min, minimal but tolerable
33.3 percentage of participants
41.2 percentage of participants
21.1 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D0, 0min, mild but tolerable
0 percentage of participants
11.8 percentage of participants
21.1 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D0, 0min, moderate but tolerable
0 percentage of participants
0 percentage of participants
5.3 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D0, 0min, moderate-severe/tolerable
0 percentage of participants
0 percentage of participants
5.3 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D0, 0min, severe and intolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D0, 15min, no pain
88.9 percentage of participants
100.0 percentage of participants
94.7 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D0, 15min, minimal but tolerable
11.1 percentage of participants
0 percentage of participants
5.3 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D0, 15min, mild but tolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D0, 15min, moderate but tolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D0, 15min, moderate-severe/tolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D0, 15min, severe and intolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D14, 0min, no pain
70.6 percentage of participants
64.7 percentage of participants
52.9 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D14, 0min, minimal but tolerable
23.5 percentage of participants
35.3 percentage of participants
17.6 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D14, 0min, mild but tolerable
5.9 percentage of participants
0 percentage of participants
11.8 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D14, 0min, moderate but tolerable
0 percentage of participants
0 percentage of participants
5.9 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D14, 0min, moderate-severe/tolerable
0 percentage of participants
0 percentage of participants
11.8 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D14, 0min, severe and intolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D14, 15min, no pain
88.2 percentage of participants
100.0 percentage of participants
82.4 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D14, 15min, minimal but tolerable
11.8 percentage of participants
0 percentage of participants
17.6 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D14, 15min, mild but tolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D14, 15min, moderate but tolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D14, 15min, moderate-severe/tolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D14, 15min, severe and intolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D28, 0min, no pain
72.2 percentage of participants
68.8 percentage of participants
55.6 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D28, 0min, minimal but tolerable
27.8 percentage of participants
18.8 percentage of participants
33.3 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D28, 0min, mild but tolerable
0 percentage of participants
12.5 percentage of participants
5.6 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D28, 0min, moderate but tolerable
0 percentage of participants
0 percentage of participants
5.6 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D28, 0min, moderate-severe/tolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D28, 0min, severe and intolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D28, 15min, no pain
100.0 percentage of participants
100.0 percentage of participants
88.9 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D28, 15min, minimal but tolerable
0 percentage of participants
0 percentage of participants
11.1 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D28, 15min, mild but tolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D28, 15min, moderate but tolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
D28, 15min, moderate-severe/tolerable
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—

SECONDARY outcome

Timeframe: Days 0, 14, 28

Population: Safety Population. Here, "n" refers to number evaluable for the specified assessment, respectively.

Device satisfaction was assessed using twelve questions on a categorical 5-point Likert scale, ranging from "strongly agree" to "strongly disagree". Question (Q) 1 (felt the autoinjection was easy to use), Q2 (felt comfortable while using the autoinjector), Q3 (felt the autoinjector was easy to hold), Q4 (able to tell when injection had completed), Q5 (felt he/she can inject properly with the autoinjector), Q6 (felt he/she had control over the injection process), Q7 (felt confident that he/she injected successfully), Q8 (felt it is easy to dispose of the autoinjector), Q9 (autoinjector would help to manage his/her injection schedule), Q10 (liked the look/feel of the autoinjector), Q11 (would recommend the autoinjector to someone else who needed to inject), Q12 (would continue having injections with the autoinjector). The percentage of participants was reported by response at each assessment among participants with RA, CGs, and HCPs.

Outcome measures

Outcome measures
Measure
RA Group 1 (Self-Administration)
n=19 Participants
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Caregivers
n=17 Participants
CGs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Healthcare Professionals
n=19 Participants
HCPs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
n=17 Participants
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
n=19 Participants
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D28, strongly disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D28, neutral
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D28, strongly agree
83.3 percentage of participants
82.4 percentage of participants
77.8 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D0, agree
44.4 percentage of participants
17.6 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D28, disagree
0 percentage of participants
5.9 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D0, strongly disagree
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D0, disagree
11.1 percentage of participants
5.9 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D14, agree
17.6 percentage of participants
6.7 percentage of participants
21.1 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D28, disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D14, strongly disagree
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D14, disagree
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
6.3 percentage of participants
5.9 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D14, disagree
5.9 percentage of participants
6.3 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D0, strongly disagree
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D0, disagree
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D0, neutral
5.6 percentage of participants
5.9 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D0, agree
11.1 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D0, strongly agree
83.3 percentage of participants
94.1 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D14, strongly disagree
11.8 percentage of participants
6.3 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D14, disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D14, neutral
0 percentage of participants
0 percentage of participants
5.3 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D14, agree
11.8 percentage of participants
12.5 percentage of participants
36.8 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D14, strongly agree
76.5 percentage of participants
81.3 percentage of participants
57.9 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D28, disagree
0 percentage of participants
11.8 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D28, neutral
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D28, agree
16.7 percentage of participants
11.8 percentage of participants
27.8 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q1, D28, strongly agree
83.3 percentage of participants
76.5 percentage of participants
72.2 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D0, strongly disagree
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D0, disagree
0 percentage of participants
5.9 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D0, neutral
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D0, agree
22.2 percentage of participants
11.8 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D0, strongly agree
77.8 percentage of participants
82.4 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D14, strongly disagree
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D14, disagree
0 percentage of participants
6.3 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D14, neutral
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D14, agree
23.5 percentage of participants
12.5 percentage of participants
42.1 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D14, strongly agree
70.6 percentage of participants
81.3 percentage of participants
57.9 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D28, strongly disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D28, disagree
0 percentage of participants
11.8 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D28, agree
16.7 percentage of participants
11.8 percentage of participants
27.8 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q2, D28, strongly agree
83.3 percentage of participants
76.5 percentage of participants
72.2 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D0, strongly disagree
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D0, disagree
5.6 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D0, neutral
5.6 percentage of participants
5.9 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D0, agree
27.8 percentage of participants
5.9 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D0, strongly agree
61.1 percentage of participants
88.2 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D14, strongly disagree
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D14, disagree
5.9 percentage of participants
6.3 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D14, neutral
0 percentage of participants
6.3 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D14, agree
17.6 percentage of participants
18.8 percentage of participants
31.6 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D14, strongly agree
70.6 percentage of participants
68.8 percentage of participants
68.4 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D28, strongly disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D28, disagree
0 percentage of participants
5.9 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D28, neutral
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q3, D28, agree
16.7 percentage of participants
11.8 percentage of participants
22.2 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D14, neutral
0 percentage of participants
0 percentage of participants
0 percentage of participants
6.3 percentage of participants
11.8 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D0, strongly disagree
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D0, disagree
11.1 percentage of participants
5.9 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D0, neutral
0 percentage of participants
5.9 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D0, strongly agree
44.4 percentage of participants
70.6 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D14, strongly disagree
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D14, disagree
5.9 percentage of participants
6.7 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D14, neutral
11.8 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D14, agree
17.6 percentage of participants
13.3 percentage of participants
31.6 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D14, strongly agree
58.8 percentage of participants
80.0 percentage of participants
68.4 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D28, strongly disagree
0 percentage of participants
5.9 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D28, disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D28, neutral
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D28, agree
22.2 percentage of participants
11.8 percentage of participants
16.7 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q4, D28, strongly agree
77.8 percentage of participants
82.4 percentage of participants
83.3 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D0, strongly disagree
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D0, disagree
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D0, neutral
11.1 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D0, agree
22.2 percentage of participants
11.8 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D0, strongly agree
66.7 percentage of participants
88.2 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D14, strongly disagree
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D14, disagree
0 percentage of participants
6.3 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D14, neutral
5.9 percentage of participants
6.3 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D14, agree
11.8 percentage of participants
0 percentage of participants
15.8 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D14, strongly agree
76.5 percentage of participants
87.5 percentage of participants
84.2 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D28, strongly disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D28, neutral
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D28, agree
16.7 percentage of participants
11.8 percentage of participants
22.2 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q5, D28, strongly agree
83.3 percentage of participants
82.4 percentage of participants
77.8 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D0, strongly disagree
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D0, disagree
5.6 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D0, neutral
5.6 percentage of participants
5.9 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D0, agree
16.7 percentage of participants
5.9 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D0, strongly agree
72.2 percentage of participants
88.2 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D14, strongly disagree
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D14, neutral
0 percentage of participants
6.3 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D14, agree
11.8 percentage of participants
12.5 percentage of participants
26.3 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D14, strongly agree
76.5 percentage of participants
75.0 percentage of participants
73.7 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D28, strongly disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D28, disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D28, neutral
0 percentage of participants
5.9 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D28, agree
16.7 percentage of participants
11.8 percentage of participants
22.2 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q6, D28, strongly agree
83.3 percentage of participants
82.4 percentage of participants
77.8 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D0, neutral
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D0, agree
16.7 percentage of participants
17.6 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D0, strongly agree
72.2 percentage of participants
76.5 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D14, strongly disagree
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D14, disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D14, neutral
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D14, strongly agree
70.6 percentage of participants
93.3 percentage of participants
78.9 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D28, strongly disagree
0 percentage of participants
5.9 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D28, neutral
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D28, agree
16.7 percentage of participants
11.8 percentage of participants
11.1 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q7, D28, strongly agree
83.3 percentage of participants
82.4 percentage of participants
88.9 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D0, strongly disagree
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D0, disagree
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D0, neutral
0 percentage of participants
0 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D0, agree
16.7 percentage of participants
5.9 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D0, strongly agree
83.3 percentage of participants
94.1 percentage of participants
—
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D14, strongly disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D14, disagree
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D14, neutral
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D14, agree
17.6 percentage of participants
0 percentage of participants
10.5 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D14, strongly agree
76.5 percentage of participants
100.0 percentage of participants
89.5 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D28, strongly disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D28, disagree
0 percentage of participants
5.9 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D28, neutral
0 percentage of participants
0 percentage of participants
0 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D28, agree
16.7 percentage of participants
11.8 percentage of participants
11.1 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q8, D28, strongly agree
83.3 percentage of participants
82.4 percentage of participants
88.9 percentage of participants
—
—
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D0, strongly disagree
0 percentage of participants
—
—
7.1 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D0, disagree
0 percentage of participants
—
—
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D0, neutral
5.6 percentage of participants
—
—
7.1 percentage of participants
17.6 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D0, agree
38.9 percentage of participants
—
—
28.6 percentage of participants
29.4 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D0, strongly agree
55.6 percentage of participants
—
—
57.1 percentage of participants
52.9 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D14, strongly disagree
0 percentage of participants
—
—
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D14, disagree (n=17,0,0,16,17)
0 percentage of participants
—
—
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D14, neutral
5.9 percentage of participants
—
—
12.5 percentage of participants
23.5 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D0, agree
33.3 percentage of participants
11.8 percentage of participants
—
21.4 percentage of participants
41.2 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D0, strongly agree
55.6 percentage of participants
76.5 percentage of participants
—
64.3 percentage of participants
47.1 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D14, agree
35.3 percentage of participants
—
—
18.8 percentage of participants
23.5 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D14, strongly agree
58.8 percentage of participants
—
—
68.8 percentage of participants
52.9 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D28, strongly disagree
0 percentage of participants
—
—
0 percentage of participants
5.6 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D28, disagree
0 percentage of participants
—
—
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D28, neutral
0 percentage of participants
—
—
12.5 percentage of participants
16.7 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D28, agree
27.8 percentage of participants
—
—
18.8 percentage of participants
33.3 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q9, D28, strongly agree
72.2 percentage of participants
—
—
68.8 percentage of participants
44.4 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D0, strongly disagree
0 percentage of participants
0 percentage of participants
—
7.1 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D0, disagree
0 percentage of participants
0 percentage of participants
—
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D0, neutral
11.1 percentage of participants
11.8 percentage of participants
—
7.1 percentage of participants
11.8 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D14, agree
23.5 percentage of participants
43.8 percentage of participants
31.6 percentage of participants
12.5 percentage of participants
41.2 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D14, strongly agree
64.7 percentage of participants
56.3 percentage of participants
68.4 percentage of participants
75.0 percentage of participants
41.2 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D28, strongly disagree
0 percentage of participants
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D0, strongly disagree
0 percentage of participants
—
—
14.3 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D28, disagree
0 percentage of participants
0 percentage of participants
0 percentage of participants
0 percentage of participants
5.6 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D28, neutral
11.1 percentage of participants
0 percentage of participants
5.6 percentage of participants
12.5 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D28, agree
16.7 percentage of participants
35.3 percentage of participants
27.8 percentage of participants
18.8 percentage of participants
44.4 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q10, D28, strongly agree
72.2 percentage of participants
58.8 percentage of participants
66.7 percentage of participants
68.8 percentage of participants
50.0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D0, strongly disagree
0 percentage of participants
0 percentage of participants
—
14.3 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D0, disagree
0 percentage of participants
0 percentage of participants
—
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D0, neutral
0 percentage of participants
5.9 percentage of participants
—
7.1 percentage of participants
5.9 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D0, agree
27.8 percentage of participants
5.9 percentage of participants
—
21.4 percentage of participants
35.3 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D0, strongly agree
72.2 percentage of participants
88.2 percentage of participants
—
57.1 percentage of participants
58.8 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D14, strongly disagree
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D14, disagree
5.9 percentage of participants
6.3 percentage of participants
0 percentage of participants
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D14, neutral
0 percentage of participants
0 percentage of participants
0 percentage of participants
6.3 percentage of participants
11.8 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D14, agree
11.8 percentage of participants
18.8 percentage of participants
21.1 percentage of participants
12.5 percentage of participants
35.3 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D14, strongly agree
76.5 percentage of participants
75.0 percentage of participants
78.9 percentage of participants
81.3 percentage of participants
52.9 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D28, strongly disagree
0 percentage of participants
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D28, neutral
0 percentage of participants
0 percentage of participants
0 percentage of participants
12.5 percentage of participants
5.6 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D28, agree
16.7 percentage of participants
5.9 percentage of participants
33.3 percentage of participants
6.3 percentage of participants
33.3 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D28, strongly agree
83.3 percentage of participants
82.4 percentage of participants
66.7 percentage of participants
81.3 percentage of participants
55.6 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D0, disagree
0 percentage of participants
—
—
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D0, agree
27.8 percentage of participants
—
—
21.4 percentage of participants
35.3 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D0, strongly agree
66.7 percentage of participants
—
—
64.3 percentage of participants
58.8 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D14, strongly disagree
5.9 percentage of participants
—
—
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D14, disagree
5.9 percentage of participants
—
—
0 percentage of participants
5.9 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D14, neutral
0 percentage of participants
—
—
6.3 percentage of participants
5.9 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D14, agree
5.9 percentage of participants
—
—
12.5 percentage of participants
35.3 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D14, strongly agree
82.4 percentage of participants
—
—
81.3 percentage of participants
52.9 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D28, strongly disagree
0 percentage of participants
—
—
0 percentage of participants
0 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D28, disagree
0 percentage of participants
—
—
6.3 percentage of participants
5.6 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D28, neutral
5.6 percentage of participants
—
—
0 percentage of participants
5.6 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D28, strongly agree
83.3 percentage of participants
—
—
68.8 percentage of participants
55.6 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q11, D28, disagree
0 percentage of participants
5.9 percentage of participants
0 percentage of participants
0 percentage of participants
5.6 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D0, neutral
5.6 percentage of participants
—
—
0 percentage of participants
5.9 percentage of participants
Percentage of Participants by Response to Device Satisfaction Questionnaire
Q12, D28, agree
11.1 percentage of participants
—
—
25.0 percentage of participants
33.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 0)

Population: Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs.

Sixty-eight joints were assessed for tenderness among participants with RA. The number of tender joints at Baseline was reported.

Outcome measures

Outcome measures
Measure
RA Group 1 (Self-Administration)
n=18 Participants
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Caregivers
n=17 Participants
CGs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Healthcare Professionals
n=19 Participants
HCPs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Tender Joint Count (TJC) Among Participants With RA
11.17 tender joints
Standard Deviation 9.32
8.12 tender joints
Standard Deviation 11.29
16.32 tender joints
Standard Deviation 16.17
—
—

SECONDARY outcome

Timeframe: Baseline (Day 0)

Population: Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs.

Sixty-six joints were assessed for swelling among participants with RA. The number of swollen joints at Baseline was reported.

Outcome measures

Outcome measures
Measure
RA Group 1 (Self-Administration)
n=18 Participants
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Caregivers
n=17 Participants
CGs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Healthcare Professionals
n=19 Participants
HCPs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Swollen Joint Count (SJC) Among Participants With RA
4.61 swollen joints
Standard Deviation 4.10
3.71 swollen joints
Standard Deviation 4.45
8.89 swollen joints
Standard Deviation 7.88
—
—

SECONDARY outcome

Timeframe: Days 0, 14, 28

Population: Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs. Here, "n" refers to number evaluable for the specified assessment, respectively.

Ability to perform daily living activities was assessed across eight component sets including dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Twenty questions were scored on a 4-point Likert scale from 0 meaning "without any difficulty" to 3 meaning "unable to do". The overall score was computed as the sum of domain scores divided by the number of domains answered. Therefore, the score range for HAQ-DI was the same as that of the individual questions, that is, from 0 to 3, where 0 indicates "least difficulty" and 3 indicates "extreme difficulty". The mean change from baseline in HAQ-DI at each assessment was reported among participants with RA.

Outcome measures

Outcome measures
Measure
RA Group 1 (Self-Administration)
n=18 Participants
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Caregivers
n=17 Participants
CGs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
Healthcare Professionals
n=19 Participants
HCPs performed injection of 162 mg SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Among Participants With RA
D0
0.7222 units on a scale
Standard Deviation 0.6974
0.8676 units on a scale
Standard Deviation 0.6532
1.2434 units on a scale
Standard Deviation 0.6541
—
—
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Among Participants With RA
Change at D14
0.0962 units on a scale
Standard Deviation 0.2166
-0.0368 units on a scale
Standard Deviation 0.1863
-0.0441 units on a scale
Standard Deviation 0.2575
—
—
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Among Participants With RA
Change at D28
0.0139 units on a scale
Standard Deviation 0.2674
-0.0078 units on a scale
Standard Deviation 0.2519
-0.0903 units on a scale
Standard Deviation 0.3398
—
—

Adverse Events

RA Group 1 (Self-Administration)

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

RA Group 2 (Administration by CG)

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

RA Group 3 (Administration by HCP)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
RA Group 1 (Self-Administration)
n=18 participants at risk
Participants with RA performed self-injection of 162 mg SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 2 (Administration by CG)
n=17 participants at risk
CGs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) was conducted for administration training, while Visits 2 and 3 (Days 14 and 28) were conducted for use/performance evaluation.
RA Group 3 (Administration by HCP)
n=19 participants at risk
HCPs performed injection of 162 mg SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs were to be professionally qualified to deliver SC injections, no administration training was provided. Visit 1 (Day 0) was performed by the study nurse. Visits 2 and 3 (Days 14 and 28) were conducted by the HCP for use/performance evaluation.
Gastrointestinal disorders
Abdominal pain
5.6%
1/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
Gastrointestinal disorders
Diarrhoea
5.6%
1/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
Gastrointestinal disorders
Pancreatitis
0.00%
0/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
5.3%
1/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
Gastrointestinal disorders
Stomatitis
0.00%
0/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
5.9%
1/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
Gastrointestinal disorders
Vomiting
5.6%
1/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
General disorders
Injection site bruising
5.6%
1/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
General disorders
Injection site pruritus
0.00%
0/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
5.9%
1/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
Immune system disorders
Hypersensitivity
5.6%
1/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
Infections and infestations
Upper respiratory tract infection
0.00%
0/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
5.9%
1/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
Injury, poisoning and procedural complications
Arthropod bite
0.00%
0/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
10.5%
2/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
Musculoskeletal and connective tissue disorders
Arthralgia
5.6%
1/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
0.00%
0/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
5.3%
1/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
Nervous system disorders
Dizziness
0.00%
0/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
5.9%
1/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
Respiratory, thoracic and mediastinal disorders
Emphysema
0.00%
0/18 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
0.00%
0/17 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
5.3%
1/19 • Days 0-28
Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Results disclosure agreements

  • Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/ or the publication be postponed in order to protect the Sponsor's intellectual property rights.
  • Publication restrictions are in place

Restriction type: OTHER