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SUNDIAL - GENENTECH U3924g

PROTOCOL: >U3924g: This study further investigates the drug rituximab when used in combination with another DMARD (disease-modifying anti-rheumatic drug).  If you participate in this research study, you will receive rituximab (study drug); there is no placebo (inactive drug).

PURPOSE AND BACKGROUND

You have been invited to participate in this research study designed to examine the safety of a drug called rituximab (RITUXAN) for rheumatoid arthritis (RA) while you are also taking other types of medicines prescribed by your doctor for your RA. These other types of medicines are called biologic or non-biologic DMARDs (Disease Modifying Anti-Rheumatic Drugs). This study includes two stages. Stage I of the study will consist of approximately 400 participants receiving non-biologic DMARDs. Stage II of the study will consist of approximately 160 participants receiving an FDA-approved biologic DMARD. Examples of DMARDs you might be taking include methotrexate, leflunomide (Arava ^â), sulfasalazine (Azulfidine^â) hydroxychloroquine (Plaquenil^â), and Azathioprine (Imuran^â).

Rituximab is a monoclonal antibody that has been approved by the Food and Drug Administration (FDA) for the treatment of non Hodgkin’s B cell lymphoma (a type of cancer) and for certain patients with RA, but has not been approved for the treatment of RA in the types of patients in this study. 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.

The purpose of this study is to further investigate the drug rituximab in the treatment of RA in combination with DMARDs. Rituximab has been given to more than 960,000 patients worldwide who have lymphoma (a type of cancer). To date, approximately 1000 patients with RA have received rituximab in clinical trials.

WHAT DOES THIS STUDY INVOLVE?

There are 12 visits scheduled over 48 weeks during this study. You will receive one course of rituximab on Day 1 and Day 15. If you are eligible you may receive an additional course between Weeks 24 and 40. An additional five visits may be scheduled over an additional 48 weeks. These additional visits are known as the “Safety Follow-Up.”

Once you have completed either the first 48 weeks of study or completed the additional 48 weeks of Safety Follow-Up, if your blood tests show that some of your white blood cell levels, called B cells, are abnormal, you may be asked to continue having study visits every 12 weeks until your B-cell level returns to normal.

Visits mentioned above include screening, treatment, safety follow-up and B-cell follow-up.

There is an initial screening period of approximately 56 days before you can start the study, followed by a treatment period of approximately 48 weeks. During that treatment period, you will receive a course (two doses) of treatment with rituximab and you will have tests done to monitor your condition. Depending on your RA status, you may be eligible for an additional course (an additional two doses) of treatment with rituximab between Weeks 24 to 40. Your participation in the study may end at any time during the screening period if you are not eligible for the study or if the study has completed enrollment.

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