Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	11/2/2018
Start Date:	March 21, 2016
End Date:	July 29, 2016

Tocilizumab Real-Life Human Factors Validation Study

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.

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.

We found this trial at

sites

Metroplex Clinical Research

Dallas, Texas 75231

from

Dallas, TX