A Study of Tocilizumab in Patients With Rheumatoid Arthritis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Condition or disease
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult rheumatoid arthritis patients with indication for treatment with tocilizumab.
≥ 18 years of age
Moderately to severely active rheumatoid arthritis
Inadequate response to previous treatment with an anti-TNF agent
Receiving methotrexate for at least 12 wks before study
Previous treatment with tocilizumab
Previous treatment with other IL-6 receptor inhibitors
Treatment with corticosteroids (oral prednisone >10 mg/day or equivalent) within 4 wks
Conditions noted in the tocilizumab prescribing information