Clinical Pharmacology Research Program

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IMPRESS - GENENTECH u3900s

PROTOCOL: U3900s: The study goal is to evaluate and compare MRI evidence of erosions and joint destruction in patients receiving rituximab to patients receiving placebo (inactive drug).

PURPOSE AND BACKGROUND

This is a research study of an investigational product called MabThera/RITUXAN (rituximab). Rituximab is a monoclonal antibody that has been approved for the treatment of non-Hodgkin’s B cell lymphoma (a type of cancer) and for certain patients with rheumatoid arthritis by the Food and Drug Administration (FDA) but has not been approved for the treatment of rheumatoid arthritis in the types of patients involved 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 rheumatoid arthritis. Rituximab has been given to more than 700,000 patients worldwide who have lymphoma (a type of cancer). To date, more than 1000 patients with rheumatoid arthritis have received rituximab in clinical trials.

The main goal of this project, however, is to evaluate a modern and sensitive technique looking at the joints of people with rheumatoid arthritis as a possible method to improve the evaluation of treatments. This technique is called magnetic resonance imaging (MRI). MRI does not use x-rays to take a picture of the joint. Instead, it uses a magnetic field, which makes the image by causing small molecules to align in the magnetic field. The MRI takes images in 3 dimensions (like we normally see things) instead of 2 dimensions. This provides a better picture. The MRI also has a better resolution, which means that the physician can see more details.

Approximately 60 patients from Oklahoma and Florida will be selected to participate in this study.

WHAT DOES THIS STUDY INVOLVE?

This is a randomized study, which means you will be assigned by chance (e.g., “toss of a coin”) to receive either rituximab or placebo (a substance with no effect). This study is also blinded, which means that you and the study doctor will not know until the end of the study whether you are receiving rituximab or placebo. Your doctor can find out if you are receiving rituximab or placebo if needed in an emergency.

Approximately 18 study visits are required during the course of this study. This includes screening, treatment, and follow up visits.

There will also be 4 MRI studies of your dominant hand and wrist performed during the course of the study. If you agree, you will be asked to have additional 4 MRI studies of the same hand and wrist performed on a small MRI system at the OMRF clinic.

There is a screening period of approximately 2 weeks, followed by a treatment period of approximately 1 year. During the treatment period, you will receive 2 weeks of treatment with rituximab or placebo and you will have tests done to monitor your condition. If you respond to treatment, you may be eligible for additional treatment with rituximab after Week 24. At the end of the treatment period, there is a 1-year safety follow-up period. Your participation in this 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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