Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

• Status: Completed
• Trial end date: 2016-07-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

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.