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Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682823
Recruitment Status : Completed
First Posted : February 15, 2016
Results First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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
Rheumatoid Arthritis Device: AI-1000 G2 Drug: Tocilizumab Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : March 21, 2016
Actual Primary Completion Date : July 29, 2016
Actual Study Completion Date : July 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Tocilizumab

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 Name: 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 Name: 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 Name: Actemra/RoActemra, RO4877533

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 Name: Actemra/RoActemra, RO4877533

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 Name: Actemra/RoActemra, RO4877533




Primary Outcome Measures :
  1. Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682823


Locations
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United States, Arizona
Arizona Arthritis and Rheuma
Mesa, Arizona, United States, 85202
United States, California
Valerius Medical Group & Research Ctr of Greater Long Beach
Los Alamitos, California, United States, 90720
Pacific Arthritis Ctr Med Grp
Santa Maria, California, United States, 93454
United States, Kentucky
Bluegrass Comm Research, Inc.
Lexington, Kentucky, United States, 40515
United States, Oklahoma
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
Advanced Rheumatology & Arthritis Research Center
Wexford, Pennsylvania, United States, 15090
United States, Texas
Metroplex Clinical Research
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02682823    
Other Study ID Numbers: WA29917
First Posted: February 15, 2016    Key Record Dates
Results First Posted: April 19, 2019
Last Update Posted: April 19, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases