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Sponsor: Hoffmann-La Roche
Conditions: Rheumatoid Arthritis
Interventions: AI-1000 G2, Tocilizumab
Countries: United States
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Mesa, Arizona, United States
- Los Alamitos, California, United States
- Santa Maria, California, United States
- Lexington, Kentucky, United States
- Tulsa, Oklahoma, United States
- Duncansville, Pennsylvania, United States
- Wexford, Pennsylvania, United States
- Dallas, Texas, United States