Clinical Pharmacology Research Program

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Download - Review of Systemic Lupus

GENENTECH u3373g #06-03

PROTOCOL: "WA17047/U3373g: A RANDOMIZED, PHASE 3 CONTROLLED, DOUBLE BLIND, PARALLEL GROUP, MULTICENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RITUXIMAB IN COMBINATION WITH METHOTREXATE (MTX) COMPARED TO MTX ALONE, IN METHOTREXATE-NAÏVE PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS.
(SPONSORED BY GENENTECH)"

PURPOSE AND BACKGROUND

You have already agreed to participate in and have signed an Informed Consent Form for Study WA17047/U3373g during which you will be receiving rituximab (MabThera^â/Rituxan^â) or placebo.  Rituximab in rheumatoid arthritis is being developed globally by Roche Products, Ltd., Biogen Idec, and Genentech, Inc.  This study will be conducted jointly by Genentech in the United States and by Roche outside of the United States.  Genentech and Roche are referred to collectively as the Sponsor.

If you agree to participate in this part of the study, you will have additional blood drawn.  The Sponsor would like to collect additional samples of your blood for further research.  Your blood sample may hold vital clues that might help researchers to understand more about rheumatoid arthritis and why people do or do not respond to treatments.

You may choose whether your samples and related medical information collected during Study WA17047/U3373g can be used for additional research related to rheumatoid arthritis or how rituximab works.  For example, you can choose whether a sample of your blood will be stored and used by researchers to learn more about the development of rheumatoid arthritis and predictors of rheumatoid arthritis progression.  This research may include determination of biochemical markers (characteristics that are measured and evaluated as indicators of normal biological or disease processes) and/or cytokine concentrations (levels of proteins in the blood that are associated with inflammation).  Research may also be done on how rituximab works in the treatment of rheumatoid arthritis.

You may also allow blood samples to be taken for additional tests that may be performed to analyze the genetic material found in your cells called ribonucleic acid (RNA).  Tests may be done on the way that RNA is expressed in the body and how it is involved in rheumatoid arthritis.  RNA is not the same as DNA.

The research to be performed with your samples may help to develop new therapies in the future.  Your blood samples and related medical information will be used only for research and will not be sold.  Your samples will not be used for any genetic analyses.  Your blood samples will not be used for DNA testing to determine or predict risk of diseases that you do not currently have.  Your blood samples will not be used for research related to the cloning of human beings.

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

Your decision to participate or not to participate in this additional research will not influence your participation in Study WA17047/U3373g, nor will it influence the medical care you receive from your doctor.

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

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