Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

Completed · Phase 4

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02682823

Run by

Hoffmann-La Roche

People needed

91

Starts

2016-03-21

Expected to finish

2016-07-29

Last updated by the study team

2019-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Arizona Arthritis and Rheuma — Mesa, Arizona, United States
• Valerius Medical Group & Research Ctr of Greater Long Beach — Los Alamitos, California, United States
• Pacific Arthritis Ctr Med Grp — Santa Maria, California, United States
• Bluegrass Comm Research, Inc. — Lexington, Kentucky, United States
• Oklahoma Center For Arthritis Therapy & Research — Tulsa, Oklahoma, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Advanced Rheumatology & Arthritis Research Center — Wexford, Pennsylvania, United States
• Metroplex Clinical Research — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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