Clinical Pharmacology Research Program

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CENTOCOR - C0524T12

PROTOCOL: C0524T12: This study investigates the experimental drug called golimumab in combination with either methotrexate or placebo (inactive methrotrexate) for treatment of RA. If you participate in this research study, you will receive either the study medication or a placebo (inactive drug).

PURPOSE AND BACKGROUND

Centocor, Inc., the sponsor of the study, is conducting a medical research study. The main purpose of this study is to assess the effects (good and bad) of golimumab on participants with Rheumatoid Arthritis.

Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body and this substance may cause long-term inflammation. Golimumab may help fight your disease by blocking the activity of TNF in your body and reducing the pain and swelling in your joints.

This study will assess the safety of intravenously (through a vein in your arm) administered golimumab and determine if there is a reduction of signs and symptoms (such as pain, stiffness, and tender and swollen joints) in participants with active Rheumatoid Arthritis who have been on a stable dose of methotrexate (MTX) treatment. The effect of intravenously administered golimumab on physical function and the quality of life in participants with Rheumatoid Arthritis will also be assessed.

HOW MANY SUBJECTS WILL TAKE PART IN THE STUDY?

About 625 participants will take part in the study at approximately 100 centers in the United States, Europe, Latin America, South America, and Asia / Pacific regions.

While you take part in this study, you may not take part in any other research studies with an investigational drug, device, or procedure.

HOW LONG WILL I BE IN THE STUDY?

There are two phases to this study: the main phase and the long-term extension phase. Your participation in the main phase of the study will last between 1-3 years, depending upon when you enter the study. The long-term extension phase of the trial will begin after your completion of the main phase of the study and will last approximately 9 months. The total length of your participation in the trial could last up to a maximum of approximately 192 weeks or 4 years.

WHAT IS INVOLVED IN THE STUDY?

If you are eligible to take part in this study, you will be randomly placed into one of the study groups below. This means you will be placed into a group based on chance, like flipping a coin. The main phase of the study is “blinded.” This means that neither you nor your study doctor will know in which group you are placed. However, if needed for safety or health reasons, your study doctor can find out your treatment at any time.

In the main phase of the study, all participants will receive IV infusions with a needle inserted into a vein in their arm. The IV infusions may be golimumab or placebo. The infusions will be given over 30 minutes in duration or longer depending upon possible side effects. Also in the main phase of the study, the study MTX capsules taken by the participants may be active MTX or placebo capsules. Placebo is an inactive or dummy treatment that looks the same as golimumab and MTX but does not contain any active medication.

After all study participants have completed 48 weeks in the study, and the study data have been verified by Centocor, and at the investigator’s discretion, participants who complete the final golimumab IV infusion and choose to continue participation in the study will begin the long-term extension phase of the study and will be switched from golimumab IV infusions to golimumab SC injections given every 4 weeks, regardless of the dose and frequency of the IV infusions they have received.

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