Clinical Pharmacology Research Program

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Download - Review of Systemic Lupus

FILM - GENENTECH WA20497/ACT3984g

PROTOCOL: Protocol WA20497/ACT3984g: This study is to determine the efficacy of ocrelizumab versus placebo when used in combination with MTX to reduce or slow down the progression of joint damage.
If you participate in this research study, you will receive either the study medication or a placebo (inactive drug).

PURPOSE AND BACKGROUND

The purpose of this study is to investigate the experimental drug ocrelizumab (PRO70769) for the treatment of rheumatoid arthritis. An experimental drug is one that is still being tested and is not approved for sale in the U.S. by the Food and Drug Administration (FDA). This study will be conducted jointly by Genentech, Inc. in the United States and by F. Hoffmann-La Roche, Ltd. (Roche) in the rest of the world. Genentech and Roche are referred to collectively as the Sponsor. Ocrelizumab for rheumatoid arthritis is being developed globally by Roche and Genentech.

Ocrelizumab is a monoclonal antibody made by Genentech. An antibody is a type of protein that helps to protect the body against foreign materials such as germs and viruses. A monoclonal antibody is a laboratory-produced protein that recognizes a specific region on cells. CD20 is a molecule found on the surface of B cells (immune cells) that may be important in inflammation (swelling). Ocrelizumab is thought to recruit the body’s natural defenses to attack and remove CD20-marked B cells (immune cells) and possibly reduce the signs and symptoms of rheumatoid arthritis.

WHAT IS INVOLVED IN THE STUDY?

This study has a screening period of up to 28 days and a double-blind treatment period of approximately 104 weeks, followed by a study extension period and, if applicable, a 48 week period of safety follow-up. The double-blind study treatment period consists of four courses of treatment (on Days 1 and 15, and on Weeks 24, 26, 52, 54, 76, and 78 for a total of eight treatments) with study drug (ocrelizumab or placebo [an inactive substance]) within 104 weeks of assessments. During this time, you will also be required to take weekly doses of methotrexate, (a drug to help with your rheumatoid arthritis).

After the end of the double blind treatment period, if your doctor thinks it might help your arthritis, and you agree to receive it, you can be given treatment with ocrelizumab during the study extension period. If you receive treatment with ocrelizumab in this period and your arthritis responds well, you can continue to receive it in this study for as long as you need it to the point it is available for sale in the United States or until the Sponsor decides not to sell it. If you have not received treatment with ocrelizumab in the third year, you will no longer be able to receive ocrelizumab after this time (Week 152).

If you decide to withdraw from the study at any time, you will be required to enter a safety follow-up period that will last 48 weeks after your last treatment with study drug or open label ocrelizumab; the time you will need to remain in safety follow up may be longer if your blood tests show low B cell counts at the 48th week after your last treatment with study drug or open label ocrelizumab.

This is a randomized study. A randomized study means you will be assigned by chance (e.g., like the toss of a coin) to receive either ocrelizumab or placebo (an inactive substance). In this study, there is a 2 out of 3 chance you will receive ocrelizumab. This study is also double-blinded, which means that you, the study doctor, and the Sponsor will not know until the end of the study whether you are receiving ocrelizumab or placebo. Your doctor can find out if you are receiving ocrelizumab or placebo if needed in an emergency. In case your arthritis worsens during the study and urgently requires additional treatment, your doctor has the option to treat you with any available and approved drug at his or her discretion. If that happens, you are encouraged to still come to the scheduled follow-up visits as outlined below.

HOW MANY SUBJECT WILL TAKE PART IN THE STUDY?

Approximately 180 participants at up to 115 study centers in the United States will be selected to participate in this study. Also, approximately 420 participants at up to 105 study centers in the rest of the world (Europe, Asia, South Africa, South America, Canada, and Australia) will be selected to participate in this study.

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