Clinical trial NCT02682823: Tocilizumab Real-Life Human Factors (RLHFs) Validation Study
Official title: Tocilizumab Real-Life Human Factors Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-02-15
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.


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.

Primary outcomes:
measure: Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use
timeFrame: Day 14
measure: Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use
timeFrame: Day 28
Secondary outcomes:
measure: Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use
timeFrame: Days 14, 28
measure: Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA
timeFrame: 0 and 15 minutes after injection on Days 0, 14, 28
measure: Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA
timeFrame: 0 and 15 minutes after injection on Days 0, 14, 28
measure: Percentage of Participants by Response to Device Satisfaction Questionnaire
timeFrame: Days 0, 14, 28
measure: Tender Joint Count (TJC) Among Participants With RA
timeFrame: Baseline (Day 0)
measure: Swollen Joint Count (SJC) Among Participants With RA
timeFrame: Baseline (Day 0)
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Among Participants With RA
timeFrame: Days 0, 14, 28
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Arthritis and Rheuma
state: Arizona
city: Los Alamitos
country: United States
facility: Valerius Medical Group & Research Ctr of Greater Long Beach
state: California
city: Santa Maria
country: United States
facility: Pacific Arthritis Ctr Med Grp
state: California
city: Lexington
country: United States
facility: Bluegrass Comm Research, Inc.
state: Kentucky
city: Tulsa
country: United States
facility: Oklahoma Center For Arthritis Therapy & Research
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Wexford
country: United States
facility: Advanced Rheumatology & Arthritis Research Center
state: Pennsylvania
city: Dallas
country: United States
facility: Metroplex Clinical Research
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Fettner S, Mela C, Wildenhahn F, Tavanti M, Wells C, Douglass W, Mallalieu NL. Evidence of bioequivalence and positive patient user handling of a tocilizumab autoinjector. Expert Opin Drug Deliv. 2019 May;16(5):551-561. doi: 10.1080/17425247.2019.1604678. Epub 2019 May 2.