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.
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
10861 Cherry Street
Los Alamitos, California 90720
Los Alamitos, California 90720
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