Clinical Pharmacology Research Program

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Download - Review of Systemic Lupus

ROSE - ROCHE ML21163

PROTOCOL: A randomized, double-blind, parallel-group study to evaluate the safety and efficacy of tocilizumab (TCZ) versus placebo in combination with disease modifying antirheumatic drugs (DMARDS) in patients with moderate to severe active rheumatoid arthritis (RA).

PURPOSE AND BACKGROUND

This study is investigating the drug tocilizumab (TCZ) for the treatment of RA in combination with a patient’s current DMARD regimen. Interleukin-6 (IL-6) is a substance in the body that is thought to be partially responsible for the inflammation that causes pain and the eventual destruction of the joints of RA patients. TCZ is a medication produced to counter act against IL-6, in turn causing less inflammation in the joints. TCZ has been given to over 4,400 patients in clinical trials throughout the US, Japan and Europe.

WHAT DOES THIS STUDY INVOLVE?

Physical exams, blood work and assessments of joints for tenderness and swelling will be done at different time points in the study; an EKG and chest x-ray are done at the screening visit. TCZ is given as an infusion into a vein over an hour; vital signs are taken at times during the infusion and for 30 minutes after. Study visits, including infusions (either drug or placebo) are done every 4 weeks until week 24; beyond this time the infusions are TCZ only.

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