This is an open-label, uncontrolled, observational study in patients with rheumatoid arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their standard of care.
This single arm, open label study evaluates the safety and pharmacodynamic profile of tocilizumab in RA patients. Participating patients are among those for whom tocilizumab is indicated and who are scheduled to receive tocilizumab as part of their normal care, in full compliance with the FDA-approved prescribing information. Study assessments consist of clinical evaluations and laboratory tests conducted in conjunction with the first three monthly intravenous infusions of tocilizumab. These assessments are designed to provide a better understanding of the pharmacodynamic effects and mechanistic actions of tocilizumab and help guide the clinical development of other therapeutic agents for RA. A total of 15 patients are expected to participate for approximately 10 weeks.
Study Type
OBSERVATIONAL
Enrollment
16
Unnamed facility
Worcester, Massachusetts, United States
Unnamed facility
Duncansville, Pennsylvania, United States
Safety (clinical and laboratory parameters)
Proportion of patients with neutropenia, elevated transaminase, and/or decreased platelet count
Time frame: Throughout the study until week 10
Treatment emergent adverse events
Post-baseline changes in vital signs, and hematological and biochemical parameters
Time frame: Throughout the study until week 10
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