Phase 4 N=91 Device Feasibility

Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT02682823 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: AI-1000 G2 (Device); Tocilizumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Jul 2016

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	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02682823). 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.