Clincosm LogoSign in Get a demo

Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02682823
Collaborator
(none)
91
Enrollment
8
Locations
5
Arms
4.3
Actual Duration (Months)
11.4
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to evaluate RLHFs concerning administration of the tocilizumab autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will be assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and healthcare professionals (HCPs) will administer the AI-1000 G2 injection to the remaining study participants.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
91 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Tocilizumab Real-Life Human Factors Validation Study
Actual Study Start Date :
Mar 21, 2016
Actual Primary Completion Date :
Jul 29, 2016
Actual Study Completion Date :
Jul 29, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Caregivers

CGs will perform injection of SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.

Device: AI-1000 G2
Tocilizumab will be administered using the AI-1000 G2.

Drug: Tocilizumab
Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
Other Names:
  • Actemra/RoActemra, RO4877533

    		•
    Experimental: Healthcare Professionals

    HCPs will perform injection of SC tocilizumab to a subset of participants with RA using the AI-1000 G2 device. Because enrolled HCPs are to be professionally qualified to deliver SC injections, no administration training will be provided. Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.

    Device: AI-1000 G2
    Tocilizumab will be administered using the AI-1000 G2.

    Drug: Tocilizumab
    Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
    Other Names:
  • Actemra/RoActemra, RO4877533

    		•
    Experimental: RA Group 1 (Self-Administration)

    Participants with RA will perform self-injection of SC tocilizumab with the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.

    Device: AI-1000 G2
    Tocilizumab will be administered using the AI-1000 G2.

    Drug: Tocilizumab
    Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
    Other Names:
  • Actemra/RoActemra, RO4877533

    		•
    Other: RA Group 2 (Administration by CG)

    CGs will perform injection of SC tocilizumab to participants with RA using the AI-1000 G2 device. Visit 1 (Day 0) will be conducted for administration training, while Visits 2 and 3 (Days 14 and 28) will be conducted for use/performance evaluation.

    Device: AI-1000 G2
    Tocilizumab will be administered using the AI-1000 G2.

    Drug: Tocilizumab
    Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
    Other Names:
  • Actemra/RoActemra, RO4877533

    		•
    Other: RA Group 3 (Administration by HCP)

    HCPs will perform injection of SC tocilizumab to participants with RA using the AI-1000 G2 device. Because enrolled HCPs are to be professionally qualified to deliver SC injections, no administration training will be provided. Visit 1 (Day 0) will be performed by the study nurse. Visits 2 and 3 (Days 14 and 28) will be conducted by the HCP for use/performance evaluation.

    Device: AI-1000 G2
    Tocilizumab will be administered using the AI-1000 G2.

    Drug: Tocilizumab
    Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
    Other Names:
  • Actemra/RoActemra, RO4877533

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use [Day 14]

      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.

    2. Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use [Day 28]

      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.

    Secondary Outcome Measures

    1. Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use [Days 14, 28]

      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.

    2. Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA [0 and 15 minutes after injection on Days 0, 14, 28]

      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.

    3. Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA [0 and 15 minutes after injection on Days 0, 14, 28]

      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.

    4. Percentage of Participants by Response to Device Satisfaction Questionnaire [Days 0, 14, 28]

      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.

    5. Tender Joint Count (TJC) Among Participants With RA [Baseline (Day 0)]

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

    6. Swollen Joint Count (SJC) Among Participants With RA [Baseline (Day 0)]

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

    7. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Among Participants With RA [Days 0, 14, 28]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants with RA for greater than or equal to (>/=6) months receiving 162 mg tocilizumab PFS-NSD for >/=8 weeks and who are suitable for continued treatment at their currently prescribed dose

    • CGs and professionally qualified HCPs who are able and willing to administer the injection

    Exclusion Criteria:

    • RA: Functional status Class IV

    • RA: Neuropathies or other conditions that might interfere with pain evaluation

    • RA: Pregnant or breastfeeding

    • RA: Low neutrophil or platelet count at last laboratory assessment

    • RA: Elevated liver enzymes at last laboratory assessment

    • Current participation in another interventional clinical trial

    • Criteria that might give the participant/CG/HCP an advantage in injection tasks such as employment in the pharmaceutical industry, etc.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Arthritis and Rheuma Mesa Arizona United States 85202
    2 Valerius Medical Group & Research Ctr of Greater Long Beach Los Alamitos California United States 90720
    3 Pacific Arthritis Ctr Med Grp Santa Maria California United States 93454
    4 Bluegrass Comm Research, Inc. Lexington Kentucky United States 40515
    5 Oklahoma Center For Arthritis Therapy & Research Tulsa Oklahoma United States 74104
    6 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
    7 Advanced Rheumatology & Arthritis Research Center Wexford Pennsylvania United States 15090
    8 Metroplex Clinical Research Dallas Texas United States 75231

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02682823
    Other Study ID Numbers:
    • WA29917
    First Posted:
    Feb 15, 2016
    Last Update Posted:
    Apr 19, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Caregivers Healthcare Professionals RA Group 1 (Self-Administration) RA Group 2 (Administration by CG) RA Group 3 (Administration by HCP)
    Arm/Group Description 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 (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. 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. 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. 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.
    Period Title: Overall Study
    STARTED 17 19 19 17 19
    Safety Population 17 19 18 17 19
    COMPLETED 17 18 18 16 18
    NOT COMPLETED 0 1 1 1 1

    Baseline Characteristics

    Arm/Group Title Caregivers Healthcare Professionals RA Group 1 (Self-Administration) RA Group 2 (Administration by CG) RA Group 3 (Administration by HCP) Total
    Arm/Group Description 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. 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. 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. 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. 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 of all reporting groups
    Overall Participants 17 19 18 17 19 90
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    15
    88.2%
    17
    89.5%
    14
    77.8%
    15
    88.2%
    16
    84.2%
    77
    85.6%
    >=65 years
    2
    11.8%
    2
    10.5%
    4
    22.2%
    2
    11.8%
    3
    15.8%
    13
    14.4%
    Sex: Female, Male (Count of Participants)
    Female
    12
    70.6%
    17
    89.5%
    13
    72.2%
    13
    76.5%
    13
    68.4%
    68
    75.6%
    Male
    5
    29.4%
    2
    10.5%
    5
    27.8%
    4
    23.5%
    6
    31.6%
    22
    24.4%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
    Description 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.
    Time Frame Day 14

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title RA Group 1 (Self-Administration) Caregivers Healthcare Professionals
    Arm/Group Description 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. 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. 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.
    Measure Participants 17 17 18
    Open carton, remove device/documents
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    Remove cap
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    Start injection
    93.75
    551.5%
    94.12
    495.4%
    100.00
    555.6%
    Hold until complete dose delivered
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    Release activation button
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    Check expiry date
    88.24
    519.1%
    58.82
    309.6%
    72.22
    401.2%
    Inspect device prior to use
    76.47
    449.8%
    47.06
    247.7%
    66.67
    370.4%
    Inspect medication prior to use
    82.35
    484.4%
    82.35
    433.4%
    88.89
    493.8%
    2. Primary Outcome
    Title Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
    Description 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.
    Time Frame Day 28

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title RA Group 1 (Self-Administration) Caregivers Healthcare Professionals
    Arm/Group Description 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. 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. 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.
    Measure Participants 18 17 18
    Open carton, remove device/documents
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    Remove cap
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    Start injection
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    Hold until complete dose delivered
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    Release activation button
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    Check expiry date
    94.44
    555.5%
    76.47
    402.5%
    94.44
    524.7%
    Inspect device prior to use
    77.78
    457.5%
    58.82
    309.6%
    83.33
    462.9%
    Inspect medication prior to use
    88.89
    522.9%
    70.59
    371.5%
    94.44
    524.7%
    3. Secondary Outcome
    Title Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
    Description 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.
    Time Frame Days 14, 28

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title RA Group 1 (Self-Administration) Caregivers Healthcare Professionals
    Arm/Group Description 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. 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. 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.
    Measure Participants 18 17 18
    Day (D) 14, wash hands
    82.35
    484.4%
    82.35
    433.4%
    77.78
    432.1%
    D28, wash hands
    88.89
    522.9%
    94.12
    495.4%
    100.00
    555.6%
    D14, clean/swab injection site
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    D28, clean/swab injection site
    94.44
    555.5%
    100.00
    526.3%
    100.00
    555.6%
    D14, wait for alcohol to dry
    94.12
    553.6%
    94.12
    495.4%
    88.89
    493.8%
    D28, wait for alcohol to dry
    82.35
    484.4%
    100.00
    526.3%
    83.33
    462.9%
    D14, dispose of device cap
    94.12
    553.6%
    86.67
    456.2%
    83.33
    462.9%
    D28, dispose of device cap
    94.44
    555.5%
    88.24
    464.4%
    94.44
    524.7%
    D14, inspect full dose delivered
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    D28, inspect full dose delivered
    94.44
    555.5%
    94.12
    495.4%
    100.00
    555.6%
    D14, dispose of device
    93.33
    549%
    100.00
    526.3%
    100.00
    555.6%
    D28, dispose of device
    94.44
    555.5%
    94.12
    495.4%
    100.00
    555.6%
    D14, treatment of site post injection
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    D28, treatment of site post injection
    100.00
    588.2%
    100.00
    526.3%
    100.00
    555.6%
    4. Secondary Outcome
    Title Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
    Description 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.
    Time Frame 0 and 15 minutes after injection on Days 0, 14, 28

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title RA Group 1 (Self-Administration) RA Group 2 (Administration by CG) RA Group 3 (Administration by HCP)
    Arm/Group Description 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. 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. 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.
    Measure Participants 18 17 19
    D0, 0 minutes (min)
    2.8
    (4.0)
    9.9
    (13.7)
    13.3
    (22.9)
    D0, 15min
    1.2
    (2.3)
    0.9
    (1.9)
    0.8
    (1.9)
    D14, 0min
    5.4
    (12.9)
    5.0
    (7.0)
    11.4
    (17.3)
    D14, 15min
    1.5
    (2.8)
    0.5
    (0.9)
    0.7
    (1.4)
    D28, 0min
    4.5
    (5.2)
    5.8
    (9.0)
    14.5
    (20.1)
    D28, 15min
    0.6
    (1.5)
    1.9
    (5.7)
    0.7
    (1.2)
    5. Secondary Outcome
    Title Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
    Description 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.
    Time Frame 0 and 15 minutes after injection on Days 0, 14, 28

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title RA Group 1 (Self-Administration) RA Group 2 (Administration by CG) RA Group 3 (Administration by HCP)
    Arm/Group Description 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. 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. 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.
    Measure Participants 18 17 19
    D0, 0min, no pain
    66.7
    392.4%
    47.1
    247.9%
    47.4
    263.3%
    D0, 0min, minimal but tolerable
    33.3
    195.9%
    41.2
    216.8%
    21.1
    117.2%
    D0, 0min, mild but tolerable
    0
    0%
    11.8
    62.1%
    21.1
    117.2%
    D0, 0min, moderate but tolerable
    0
    0%
    0
    0%
    5.3
    29.4%
    D0, 0min, moderate-severe/tolerable
    0
    0%
    0
    0%
    5.3
    29.4%
    D0, 0min, severe and intolerable
    0
    0%
    0
    0%
    0
    0%
    D0, 15min, no pain
    88.9
    522.9%
    100.0
    526.3%
    94.7
    526.1%
    D0, 15min, minimal but tolerable
    11.1
    65.3%
    0
    0%
    5.3
    29.4%
    D0, 15min, mild but tolerable
    0
    0%
    0
    0%
    0
    0%
    D0, 15min, moderate but tolerable
    0
    0%
    0
    0%
    0
    0%
    D0, 15min, moderate-severe/tolerable
    0
    0%
    0
    0%
    0
    0%
    D0, 15min, severe and intolerable
    0
    0%
    0
    0%
    0
    0%
    D14, 0min, no pain
    70.6
    415.3%
    64.7
    340.5%
    52.9
    293.9%
    D14, 0min, minimal but tolerable
    23.5
    138.2%
    35.3
    185.8%
    17.6
    97.8%
    D14, 0min, mild but tolerable
    5.9
    34.7%
    0
    0%
    11.8
    65.6%
    D14, 0min, moderate but tolerable
    0
    0%
    0
    0%
    5.9
    32.8%
    D14, 0min, moderate-severe/tolerable
    0
    0%
    0
    0%
    11.8
    65.6%
    D14, 0min, severe and intolerable
    0
    0%
    0
    0%
    0
    0%
    D14, 15min, no pain
    88.2
    518.8%
    100.0
    526.3%
    82.4
    457.8%
    D14, 15min, minimal but tolerable
    11.8
    69.4%
    0
    0%
    17.6
    97.8%
    D14, 15min, mild but tolerable
    0
    0%
    0
    0%
    0
    0%
    D14, 15min, moderate but tolerable
    0
    0%
    0
    0%
    0
    0%
    D14, 15min, moderate-severe/tolerable
    0
    0%
    0
    0%
    0
    0%
    D14, 15min, severe and intolerable
    0
    0%
    0
    0%
    0
    0%
    D28, 0min, no pain
    72.2
    424.7%
    68.8
    362.1%
    55.6
    308.9%
    D28, 0min, minimal but tolerable
    27.8
    163.5%
    18.8
    98.9%
    33.3
    185%
    D28, 0min, mild but tolerable
    0
    0%
    12.5
    65.8%
    5.6
    31.1%
    D28, 0min, moderate but tolerable
    0
    0%
    0
    0%
    5.6
    31.1%
    D28, 0min, moderate-severe/tolerable
    0
    0%
    0
    0%
    0
    0%
    D28, 0min, severe and intolerable
    0
    0%
    0
    0%
    0
    0%
    D28, 15min, no pain
    100.0
    588.2%
    100.0
    526.3%
    88.9
    493.9%
    D28, 15min, minimal but tolerable
    0
    0%
    0
    0%
    11.1
    61.7%
    D28, 15min, mild but tolerable
    0
    0%
    0
    0%
    0
    0%
    D28, 15min, moderate but tolerable
    0
    0%
    0
    0%
    0
    0%
    D28, 15min, moderate-severe/tolerable
    0
    0%
    0
    0%
    0
    0%
    D28, 15min, severe and intolerable
    0
    0%
    0
    0%
    0
    0%
    6. Secondary Outcome
    Title Percentage of Participants by Response to Device Satisfaction Questionnaire
    Description 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.
    Time Frame Days 0, 14, 28

    Outcome Measure Data

    Analysis Population Description
    Safety Population. Here, "n" refers to number evaluable for the specified assessment, respectively.
    Arm/Group Title RA Group 1 (Self-Administration) Caregivers Healthcare Professionals RA Group 2 (Administration by CG) RA Group 3 (Administration by HCP)
    Arm/Group Description 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. 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. 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. 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. 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.
    Measure Participants 19 17 19 17 19
    Q1, D0, strongly disagree
    0
    0%
    0
    0%
    Q1, D0, disagree
    0
    0%
    0
    0%
    Q1, D0, neutral
    5.6
    32.9%
    5.9
    31.1%
    Q1, D0, agree
    11.1
    65.3%
    0
    0%
    Q1, D0, strongly agree
    83.3
    490%
    94.1
    495.3%
    Q1, D14, strongly disagree
    11.8
    69.4%
    6.3
    33.2%
    0
    0%
    Q1, D14, disagree
    0
    0%
    0
    0%
    0
    0%
    Q1, D14, neutral
    0
    0%
    0
    0%
    5.3
    29.4%
    Q1, D14, agree
    11.8
    69.4%
    12.5
    65.8%
    36.8
    204.4%
    Q1, D14, strongly agree
    76.5
    450%
    81.3
    427.9%
    57.9
    321.7%
    Q1, D28, strongly disagree
    0
    0%
    0
    0%
    0
    0%
    Q1, D28, disagree
    0
    0%
    11.8
    62.1%
    0
    0%
    Q1, D28, neutral
    0
    0%
    0
    0%
    0
    0%
    Q1, D28, agree
    16.7
    98.2%
    11.8
    62.1%
    27.8
    154.4%
    Q1, D28, strongly agree
    83.3
    490%
    76.5
    402.6%
    72.2
    401.1%
    Q2, D0, strongly disagree
    0
    0%
    0
    0%
    Q2, D0, disagree
    0
    0%
    5.9
    31.1%
    Q2, D0, neutral
    0
    0%
    0
    0%
    Q2, D0, agree
    22.2
    130.6%
    11.8
    62.1%
    Q2, D0, strongly agree
    77.8
    457.6%
    82.4
    433.7%
    Q2, D14, strongly disagree
    5.9
    34.7%
    0
    0%
    0
    0%
    Q2, D14, disagree
    0
    0%
    6.3
    33.2%
    0
    0%
    Q2, D14, neutral
    0
    0%
    0
    0%
    0
    0%
    Q2, D14, agree
    23.5
    138.2%
    12.5
    65.8%
    42.1
    233.9%
    Q2, D14, strongly agree
    70.6
    415.3%
    81.3
    427.9%
    57.9
    321.7%
    Q2, D28, strongly disagree
    0
    0%
    0
    0%
    0
    0%
    Q2, D28, disagree
    0
    0%
    11.8
    62.1%
    0
    0%
    Q2, D28, neutral
    0
    0%
    0
    0%
    0
    0%
    Q2, D28, agree
    16.7
    98.2%
    11.8
    62.1%
    27.8
    154.4%
    Q2, D28, strongly agree
    83.3
    490%
    76.5
    402.6%
    72.2
    401.1%
    Q3, D0, strongly disagree
    0
    0%
    0
    0%
    Q3, D0, disagree
    5.6
    32.9%
    0
    0%
    Q3, D0, neutral
    5.6
    32.9%
    5.9
    31.1%
    Q3, D0, agree
    27.8
    163.5%
    5.9
    31.1%
    Q3, D0, strongly agree
    61.1
    359.4%
    88.2
    464.2%
    Q3, D14, strongly disagree
    5.9
    34.7%
    0
    0%
    0
    0%
    Q3, D14, disagree
    5.9
    34.7%
    6.3
    33.2%
    0
    0%
    Q3, D14, neutral
    0
    0%
    6.3
    33.2%
    0
    0%
    Q3, D14, agree
    17.6
    103.5%
    18.8
    98.9%
    31.6
    175.6%
    Q3, D14, strongly agree
    70.6
    415.3%
    68.8
    362.1%
    68.4
    380%
    Q3, D28, strongly disagree
    0
    0%
    0
    0%
    0
    0%
    Q3, D28, disagree
    0
    0%
    5.9
    31.1%
    0
    0%
    Q3, D28, neutral
    0
    0%
    0
    0%
    0
    0%
    Q3, D28, agree
    16.7
    98.2%
    11.8
    62.1%
    22.2
    123.3%
    Q3, D28, strongly agree
    83.3
    490%
    82.4
    433.7%
    77.8
    432.2%
    Q4, D0, strongly disagree
    0
    0%
    0
    0%
    Q4, D0, disagree
    11.1
    65.3%
    5.9
    31.1%
    Q4, D0, neutral
    0
    0%
    5.9
    31.1%
    Q4, D0, agree
    44.4
    261.2%
    17.6
    92.6%
    Q4, D0, strongly agree
    44.4
    261.2%
    70.6
    371.6%
    Q4, D14, strongly disagree
    5.9
    34.7%
    0
    0%
    0
    0%
    Q4, D14, disagree
    5.9
    34.7%
    6.7
    35.3%
    0
    0%
    Q4, D14, neutral
    11.8
    69.4%
    0
    0%
    0
    0%
    Q4, D14, agree
    17.6
    103.5%
    13.3
    70%
    31.6
    175.6%
    Q4, D14, strongly agree
    58.8
    345.9%
    80.0
    421.1%
    68.4
    380%
    Q4, D28, strongly disagree
    0
    0%
    5.9
    31.1%
    0
    0%
    Q4, D28, disagree
    0
    0%
    0
    0%
    0
    0%
    Q4, D28, neutral
    0
    0%
    0
    0%
    0
    0%
    Q4, D28, agree
    22.2
    130.6%
    11.8
    62.1%
    16.7
    92.8%
    Q4, D28, strongly agree
    77.8
    457.6%
    82.4
    433.7%
    83.3
    462.8%
    Q5, D0, strongly disagree
    0
    0%
    0
    0%
    Q5, D0, disagree
    0
    0%
    0
    0%
    Q5, D0, neutral
    11.1
    65.3%
    0
    0%
    Q5, D0, agree
    22.2
    130.6%
    11.8
    62.1%
    Q5, D0, strongly agree
    66.7
    392.4%
    88.2
    464.2%
    Q5, D14, strongly disagree
    5.9
    34.7%
    0
    0%
    0
    0%
    Q5, D14, disagree
    0
    0%
    6.3
    33.2%
    0
    0%
    Q5, D14, neutral
    5.9
    34.7%
    6.3
    33.2%
    0
    0%
    Q5, D14, agree
    11.8
    69.4%
    0
    0%
    15.8
    87.8%
    Q5, D14, strongly agree
    76.5
    450%
    87.5
    460.5%
    84.2
    467.8%
    Q5, D28, strongly disagree
    0
    0%
    0
    0%
    0
    0%
    Q5, D28, disagree
    0
    0%
    5.9
    31.1%
    0
    0%
    Q5, D28, neutral
    0
    0%
    0
    0%
    0
    0%
    Q5, D28, agree
    16.7
    98.2%
    11.8
    62.1%
    22.2
    123.3%
    Q5, D28, strongly agree
    83.3
    490%
    82.4
    433.7%
    77.8
    432.2%
    Q6, D0, strongly disagree
    0
    0%
    0
    0%
    Q6, D0, disagree
    5.6
    32.9%
    0
    0%
    Q6, D0, neutral
    5.6
    32.9%
    5.9
    31.1%
    Q6, D0, agree
    16.7
    98.2%
    5.9
    31.1%
    Q6, D0, strongly agree
    72.2
    424.7%
    88.2
    464.2%
    Q6, D14, strongly disagree
    5.9
    34.7%
    0
    0%
    0
    0%
    Q6, D14, disagree
    5.9
    34.7%
    6.3
    33.2%
    0
    0%
    Q6, D14, neutral
    0
    0%
    6.3
    33.2%
    0
    0%
    Q6, D14, agree
    11.8
    69.4%
    12.5
    65.8%
    26.3
    146.1%
    Q6, D14, strongly agree
    76.5
    450%
    75.0
    394.7%
    73.7
    409.4%
    Q6, D28, strongly disagree
    0
    0%
    0
    0%
    0
    0%
    Q6, D28, disagree
    0
    0%
    0
    0%
    0
    0%
    Q6, D28, neutral
    0
    0%
    5.9
    31.1%
    0
    0%
    Q6, D28, agree
    16.7
    98.2%
    11.8
    62.1%
    22.2
    123.3%
    Q6, D28, strongly agree
    83.3
    490%
    82.4
    433.7%
    77.8
    432.2%
    Q7, D0, strongly disagree
    0
    0%
    0
    0%
    Q7, D0, disagree
    11.1
    65.3%
    5.9
    31.1%
    Q7, D0, neutral
    0
    0%
    0
    0%
    Q7, D0, agree
    16.7
    98.2%
    17.6
    92.6%
    Q7, D0, strongly agree
    72.2
    424.7%
    76.5
    402.6%
    Q7, D14, strongly disagree
    5.9
    34.7%
    0
    0%
    0
    0%
    Q7, D14, disagree
    0
    0%
    0
    0%
    0
    0%
    Q7, D14, neutral
    5.9
    34.7%
    0
    0%
    0
    0%
    Q7, D14, agree
    17.6
    103.5%
    6.7
    35.3%
    21.1
    117.2%
    Q7, D14, strongly agree
    70.6
    415.3%
    93.3
    491.1%
    78.9
    438.3%
    Q7, D28, strongly disagree
    0
    0%
    5.9
    31.1%
    0
    0%
    Q7, D28, disagree
    0
    0%
    0
    0%
    0
    0%
    Q7, D28, neutral
    0
    0%
    0
    0%
    0
    0%
    Q7, D28, agree
    16.7
    98.2%
    11.8
    62.1%
    11.1
    61.7%
    Q7, D28, strongly agree
    83.3
    490%
    82.4
    433.7%
    88.9
    493.9%
    Q8, D0, strongly disagree
    0
    0%
    0
    0%
    Q8, D0, disagree
    0
    0%
    0
    0%
    Q8, D0, neutral
    0
    0%
    0
    0%
    Q8, D0, agree
    16.7
    98.2%
    5.9
    31.1%
    Q8, D0, strongly agree
    83.3
    490%
    94.1
    495.3%
    Q8, D14, strongly disagree
    0
    0%
    0
    0%
    0
    0%
    Q8, D14, disagree
    5.9
    34.7%
    0
    0%
    0
    0%
    Q8, D14, neutral
    0
    0%
    0
    0%
    0
    0%
    Q8, D14, agree
    17.6
    103.5%
    0
    0%
    10.5
    58.3%
    Q8, D14, strongly agree
    76.5
    450%
    100.0
    526.3%
    89.5
    497.2%
    Q8, D28, strongly disagree
    0
    0%
    0
    0%
    0
    0%
    Q8, D28, disagree
    0
    0%
    5.9
    31.1%
    0
    0%
    Q8, D28, neutral
    0
    0%
    0
    0%
    0
    0%
    Q8, D28, agree
    16.7
    98.2%
    11.8
    62.1%
    11.1
    61.7%
    Q8, D28, strongly agree
    83.3
    490%
    82.4
    433.7%
    88.9
    493.9%
    Q9, D0, strongly disagree
    0
    0%
    7.1
    37.4%
    0
    0%
    Q9, D0, disagree
    0
    0%
    0
    0%
    0
    0%
    Q9, D0, neutral
    5.6
    32.9%
    7.1
    37.4%
    17.6
    97.8%
    Q9, D0, agree
    38.9
    228.8%
    28.6
    150.5%
    29.4
    163.3%
    Q9, D0, strongly agree
    55.6
    327.1%
    57.1
    300.5%
    52.9
    293.9%
    Q9, D14, strongly disagree
    0
    0%
    0
    0%
    0
    0%
    Q9, D14, disagree (n=17,0,0,16,17)
    0
    0%
    0
    0%
    0
    0%
    Q9, D14, neutral
    5.9
    34.7%
    12.5
    65.8%
    23.5
    130.6%
    Q9, D14, agree
    35.3
    207.6%
    18.8
    98.9%
    23.5
    130.6%
    Q9, D14, strongly agree
    58.8
    345.9%
    68.8
    362.1%
    52.9
    293.9%
    Q9, D28, strongly disagree
    0
    0%
    0
    0%
    5.6
    31.1%
    Q9, D28, disagree
    0
    0%
    0
    0%
    0
    0%
    Q9, D28, neutral
    0
    0%
    12.5
    65.8%
    16.7
    92.8%
    Q9, D28, agree
    27.8
    163.5%
    18.8
    98.9%
    33.3
    185%
    Q9, D28, strongly agree
    72.2
    424.7%
    68.8
    362.1%
    44.4
    246.7%
    Q10, D0, strongly disagree
    0
    0%
    0
    0%
    7.1
    39.4%
    0
    0%
    Q10, D0, disagree
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Q10, D0, neutral
    11.1
    65.3%
    11.8
    62.1%
    7.1
    39.4%
    11.8
    69.4%
    Q10, D0, agree
    33.3
    195.9%
    11.8
    62.1%
    21.4
    118.9%
    41.2
    242.4%
    Q10, D0, strongly agree
    55.6
    327.1%
    76.5
    402.6%
    64.3
    357.2%
    47.1
    277.1%
    Q10, D14, strongly disagree
    5.9
    34.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Q10, D14, disagree
    5.9
    34.7%
    0
    0%
    0
    0%
    6.3
    37.1%
    5.9
    31.1%
    Q10, D14, neutral
    0
    0%
    0
    0%
    0
    0%
    6.3
    37.1%
    11.8
    62.1%
    Q10, D14, agree
    23.5
    138.2%
    43.8
    230.5%
    31.6
    175.6%
    12.5
    73.5%
    41.2
    216.8%
    Q10, D14, strongly agree
    64.7
    380.6%
    56.3
    296.3%
    68.4
    380%
    75.0
    441.2%
    41.2
    216.8%
    Q10, D28, strongly disagree
    0
    0%
    5.9
    31.1%
    0
    0%
    0
    0%
    0
    0%
    Q10, D28, disagree
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    5.6
    29.5%
    Q10, D28, neutral
    11.1
    65.3%
    0
    0%
    5.6
    31.1%
    12.5
    73.5%
    0
    0%
    Q10, D28, agree
    16.7
    98.2%
    35.3
    185.8%
    27.8
    154.4%
    18.8
    110.6%
    44.4
    233.7%
    Q10, D28, strongly agree
    72.2
    424.7%
    58.8
    309.5%
    66.7
    370.6%
    68.8
    404.7%
    50.0
    263.2%
    Q11, D0, strongly disagree
    0
    0%
    0
    0%
    14.3
    79.4%
    0
    0%
    Q11, D0, disagree
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Q11, D0, neutral
    0
    0%
    5.9
    31.1%
    7.1
    39.4%
    5.9
    34.7%
    Q11, D0, agree
    27.8
    163.5%
    5.9
    31.1%
    21.4
    118.9%
    35.3
    207.6%
    Q11, D0, strongly agree
    72.2
    424.7%
    88.2
    464.2%
    57.1
    317.2%
    58.8
    345.9%
    Q11, D14, strongly disagree
    5.9
    34.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Q11, D14, disagree
    5.9
    34.7%
    6.3
    33.2%
    0
    0%
    0
    0%
    0
    0%
    Q11, D14, neutral
    0
    0%
    0
    0%
    0
    0%
    6.3
    37.1%
    11.8
    62.1%
    Q11, D14, agree
    11.8
    69.4%
    18.8
    98.9%
    21.1
    117.2%
    12.5
    73.5%
    35.3
    185.8%
    Q11, D14, strongly agree
    76.5
    450%
    75.0
    394.7%
    78.9
    438.3%
    81.3
    478.2%
    52.9
    278.4%
    Q11, D28, strongly disagree
    0
    0%
    5.9
    31.1%
    0
    0%
    0
    0%
    0
    0%
    Q11, D28, disagree
    0
    0%
    5.9
    31.1%
    0
    0%
    0
    0%
    5.6
    29.5%
    Q11, D28, neutral
    0
    0%
    0
    0%
    0
    0%
    12.5
    73.5%
    5.6
    29.5%
    Q11, D28, agree
    16.7
    98.2%
    5.9
    31.1%
    33.3
    185%
    6.3
    37.1%
    33.3
    175.3%
    Q11, D28, strongly agree
    83.3
    490%
    82.4
    433.7%
    66.7
    370.6%
    81.3
    478.2%
    55.6
    292.6%
    Q12, D0, strongly disagree
    0
    0%
    14.3
    75.3%
    0
    0%
    Q12, D0, disagree
    0
    0%
    0
    0%
    0
    0%
    Q12, D0, neutral
    5.6
    32.9%
    0
    0%
    5.9
    32.8%
    Q12, D0, agree
    27.8
    163.5%
    21.4
    112.6%
    35.3
    196.1%
    Q12, D0, strongly agree
    66.7
    392.4%
    64.3
    338.4%
    58.8
    326.7%
    Q12, D14, strongly disagree
    5.9
    34.7%
    0
    0%
    0
    0%
    Q12, D14, disagree
    5.9
    34.7%
    0
    0%
    5.9
    32.8%
    Q12, D14, neutral
    0
    0%
    6.3
    33.2%
    5.9
    32.8%
    Q12, D14, agree
    5.9
    34.7%
    12.5
    65.8%
    35.3
    196.1%
    Q12, D14, strongly agree
    82.4
    484.7%
    81.3
    427.9%
    52.9
    293.9%
    Q12, D28, strongly disagree
    0
    0%
    0
    0%
    0
    0%
    Q12, D28, disagree
    0
    0%
    6.3
    33.2%
    5.6
    31.1%
    Q12, D28, neutral
    5.6
    32.9%
    0
    0%
    5.6
    31.1%
    Q12, D28, agree
    11.1
    65.3%
    25.0
    131.6%
    33.3
    185%
    Q12, D28, strongly agree
    83.3
    490%
    68.8
    362.1%
    55.6
    308.9%
    7. Secondary Outcome
    Title Tender Joint Count (TJC) Among Participants With RA
    Description Sixty-eight joints were assessed for tenderness among participants with RA. The number of tender joints at Baseline was reported.
    Time Frame Baseline (Day 0)

    Outcome Measure Data

    Analysis Population Description
    Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs.
    Arm/Group Title RA Group 1 (Self-Administration) RA Group 2 (Administration by CG) RA Group 3 (Administration by HCP)
    Arm/Group Description 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. 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. 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.
    Measure Participants 18 17 19
    Mean (Standard Deviation) [tender joints]
    11.17
    (9.32)
    8.12
    (11.29)
    16.32
    (16.17)
    8. Secondary Outcome
    Title Swollen Joint Count (SJC) Among Participants With RA
    Description Sixty-six joints were assessed for swelling among participants with RA. The number of swollen joints at Baseline was reported.
    Time Frame Baseline (Day 0)

    Outcome Measure Data

    Analysis Population Description
    Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs.
    Arm/Group Title RA Group 1 (Self-Administration) RA Group 2 (Administration by CG) RA Group 3 (Administration by HCP)
    Arm/Group Description 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. 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. 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.
    Measure Participants 18 17 19
    Mean (Standard Deviation) [swollen joints]
    4.61
    (4.10)
    3.71
    (4.45)
    8.89
    (7.88)
    9. Secondary Outcome
    Title Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Among Participants With RA
    Description 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.
    Time Frame Days 0, 14, 28

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title RA Group 1 (Self-Administration) RA Group 2 (Administration by CG) RA Group 3 (Administration by HCP)
    Arm/Group Description 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. 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. 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.
    Measure Participants 18 17 19
    D0
    0.7222
    (0.6974)
    0.8676
    (0.6532)
    1.2434
    (0.6541)
    Change at D14
    0.0962
    (0.2166)
    -0.0368
    (0.1863)
    -0.0441
    (0.2575)
    Change at D28
    0.0139
    (0.2674)
    -0.0078
    (0.2519)
    -0.0903
    (0.3398)

    Adverse Events

    Time Frame Days 0-28
    Adverse Event Reporting Description Safety Population; only participants with RA were assessed for adverse events. CGs and HCPs were not included in the analysis.
    Arm/Group Title RA Group 1 (Self-Administration) RA Group 2 (Administration by CG) RA Group 3 (Administration by HCP)
    Arm/Group Description 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. 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. 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.
    All Cause Mortality
    RA Group 1 (Self-Administration) RA Group 2 (Administration by CG) RA Group 3 (Administration by HCP)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    RA Group 1 (Self-Administration) RA Group 2 (Administration by CG) RA Group 3 (Administration by HCP)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/18 (0%) 0/17 (0%) 0/19 (0%)
    Other (Not Including Serious) Adverse Events
    RA Group 1 (Self-Administration) RA Group 2 (Administration by CG) RA Group 3 (Administration by HCP)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/18 (22.2%) 4/17 (23.5%) 3/19 (15.8%)
    Gastrointestinal disorders
    Abdominal pain 1/18 (5.6%) 0/17 (0%) 0/19 (0%)
    Diarrhoea 1/18 (5.6%) 0/17 (0%) 0/19 (0%)
    Pancreatitis 0/18 (0%) 0/17 (0%) 1/19 (5.3%)
    Stomatitis 0/18 (0%) 1/17 (5.9%) 0/19 (0%)
    Vomiting 1/18 (5.6%) 0/17 (0%) 0/19 (0%)
    General disorders
    Injection site bruising 1/18 (5.6%) 0/17 (0%) 0/19 (0%)
    Injection site pruritus 0/18 (0%) 1/17 (5.9%) 0/19 (0%)
    Immune system disorders
    Hypersensitivity 1/18 (5.6%) 0/17 (0%) 0/19 (0%)
    Infections and infestations
    Upper respiratory tract infection 0/18 (0%) 1/17 (5.9%) 0/19 (0%)
    Injury, poisoning and procedural complications
    Arthropod bite 0/18 (0%) 0/17 (0%) 2/19 (10.5%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/18 (5.6%) 0/17 (0%) 0/19 (0%)
    Rheumatoid arthritis 0/18 (0%) 0/17 (0%) 1/19 (5.3%)
    Nervous system disorders
    Dizziness 0/18 (0%) 1/17 (5.9%) 0/19 (0%)
    Respiratory, thoracic and mediastinal disorders
    Emphysema 0/18 (0%) 0/17 (0%) 1/19 (5.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/Title Medical Communications
    Organization Hoffmann-La Roche
    Phone 800-821-8590
    Email genentech@druginfo.com
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02682823
    Other Study ID Numbers:
    • WA29917
    First Posted:
    Feb 15, 2016
    Last Update Posted:
    Apr 19, 2019
    Last Verified:
    Jan 1, 2019