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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
91
Tocilizumab will be administered using the AI-1000 G2.
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.
Arizona Arthritis and Rheuma
Mesa, Arizona, United States
Valerius Medical Group & Research Ctr of Greater Long Beach
Los Alamitos, California, United States
Pacific Arthritis Ctr Med Grp
Santa Maria, California, United States
Bluegrass Comm Research, Inc.
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
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
Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
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
Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
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Lexington, Kentucky, United States
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Advanced Rheumatology & Arthritis Research Center
Wexford, Pennsylvania, United States
Metroplex Clinical Research
Dallas, Texas, United States
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
Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
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
Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
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
Percentage of Participants by Response to Device Satisfaction Questionnaire
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
Tender Joint Count (TJC) Among Participants With RA
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)
Swollen Joint Count (SJC) Among Participants With RA
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)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Among Participants With RA
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