Clinical Pharmacology Research Program

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Information for Participation

Download - Review of Systemic Lupus

GENENTECH u2973g #05-23

PROTOCOL: "Genentech u2973g #05-23"

PURPOSE AND BACKGROUND

The purpose of this Informed Consent Form is to inform you about the nature of this research study so that you may make an informed decision whether you would like to participate and to inform the study doctor of how your personal health information may be used or given to others during the study and after the study is finished.

This is a research study of an investigational product called rituximab (MabThera/Rituxan). Rituximab is a monoclonal antibody that has been approved for the treatment of non-Hodgkin’s B cell lymphoma (a type of cancer) by the Food and Drug Administration (FDA) but has not been approved for the treatment of rheumatoid arthritis. This study will be conducted jointly by Genentech, Inc. in the United States and by Roche Products, Ltd. in the rest of the world. Genentech and Roche are referred to collectively as the Sponsor. Rituximab in rheumatoid arthritis is being developed globally by Roche, Biogen Idec, and Genentech.

An antibody is a type of protein that is made in the body in response to a foreign substance and attacks and protects against infection. A monoclonal antibody is a laboratory-produced substance that recognizes a specific region on cells. CD20 is a molecule on the surface of B cells (immune cells) that may be important in inflammation. Rituximab binds CD20 and is thought to help the body attack and destroy marked B cells.

Your participation in this study is entirely voluntary. You will be invited to sign this informed consent if you are interested in participating in this study. You may withdraw from this study at any time for any reason without affecting your existing medical care.

The purpose of this study is to further investigate the drug rituximab in the treatment of rheumatoid arthritis. Rituximab has been given to more than 500,000 patients worldwide who have lymphoma (a type of cancer). To date, approximately 1000 patients with rheumatoid arthritis have received rituximab in clinical trials. You are being invited to participate in this research study because you have been diagnosed with active, moderate-to-severe rheumatoid arthritis. Approximately 500 patients from the United States, Canada, Asia Pacific, and Europe will be selected to participate in this study.

You understand that signing this Informed Consent Form does not necessarily mean that you are eligible for participation in this study. Many tests need to be performed, and it is possible that the results of these tests will reveal that you are not eligible.

CALL FOR INFORMATION OR QUESTIONS CONCERNING THIS STUDY: (405) 271-7805

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