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

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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
8
sites
1500 South Dobson Road
Mesa, Arizona 85202
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Mesa, AZ
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Dallas, Texas 75231
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Dallas, TX
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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470 Cooper Drive
Lexington, Kentucky 40515
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Lexington, KY
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10861 Cherry Street
Los Alamitos, California 90720
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Los Alamitos, CA
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Santa Maria, California 93454
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Santa Maria, CA
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Tulsa, OK
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Wexford, PA
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