Phase 4
Completed N=91
Tocilizumab Real-Life Human Factors (RLHFs) Validation Study
Source: ClinicalTrials.gov NCT02682823 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use — 100.00; 100.00; 100.00; 100.00 percentage of participants
◆ Published Evidence
Emerging
16citations · ~2 / year
Evidence of bioequivalence and positive patient user handling of a tocilizumab autoinjector.
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.
Linked Publications
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Evidence of bioequivalence and positive patient user handling of a tocilizumab autoinjector.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use |
100.00; 100.00; 100.00; 100.00; 100.00; 100.00 | — |
| PRIMARY Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use |
100.00; 100.00; 100.00; 100.00; 100.00; 100.00 | — |
| SECONDARY Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use |
82.35; 82.35; 77.78; 88.89; 94.12; 100.00 | — |
| SECONDARY Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA |
2.8; 9.9; 13.3; 1.2; 0.9; 0.8 | — |
| SECONDARY Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA |
66.7; 47.1; 47.4; 33.3; 41.2; 21.1 | — |
| SECONDARY Percentage of Participants by Response to Device Satisfaction Questionnaire |
0; 0; 0; 0; 5.6; 5.9 | — |
| SECONDARY Tender Joint Count (TJC) Among Participants With RA |
11.17; 8.12; 16.32 | — |
| SECONDARY Swollen Joint Count (SJC) Among Participants With RA |
4.61; 3.71; 8.89 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Among Participants With RA |
0.7222; 0.8676; 1.2434; 0.0962; -0.0368; -0.0441 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02682823) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.