Clinical Pharmacology Research Program

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SCRIPT - GENENTECH WA20495/ACT3986g

PROTOCOL: Protocol WA20495/ACT3986g: This study investigates the experimental drug called ocrelizumab in combination with either methotrexate or Arava (leflunomide) for the treatment of RA in patients who have tried one of the new biologics (Enbrel, Humira, Remicaide) in the past. 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. You are being invited to participate in this research study because you have been diagnosed with active
Rheumatoid arthritis and you have had unsuccessful treatment with at least one anti-TNF therapy (for example, etanercept [Enbrel®], infliximab [Remicade®], or adalimumab [Humira®].

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 84 days and a double-blind treatment period of approximately 48 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 two courses of treatment (on Days 1 and 15 and on Weeks 24 and 26, for a total of four treatments) with study drug (ocrelizumab or placebo [an inactive substance]) within 48 weeks of assessments. During this time, you will also be required to take doses of methotrexate or leflunomide (drugs that you may already be taking 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 second year, you will no longer be able to receive ocrelizumab after this time (Week 96).

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 500 participants at up to 150 study centers in the United States will be selected to participate in this study. Also, approximately 500 participants at up to 125 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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