Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

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.