Important Information About a

Clinical Research Study Opportunity

for People with Gout

If you or your family has been coping with GOUT,

Now Is the Time to Act!

Whether your gout is currently on the attack or in hiding, now is the time to act!

Are you worried about the swelling and burning pain of your next gout attack? If so, It’s time to take action? Participate in a a clinical trial!

Increase serum uric acid levels in the body can cause gout attacks. When gout isn’t propertly treated over time, gout attacks can become more severe, last longer, and happen more often.

Are you interested in receiving study-related medical care for your gout?

Whether you’re having a gout attack now or it’s been a while since your last gout attack, you may be able to take part in a research study of an investigational drug for gout under the careful direction of an experienced clinical research team.

Don’t wait for the next time your gout attacks to do something about it. Now is the time to act! It doesn’t matter if you are currently treating your gout or not; you may still qualify for this study.

This brochure provides information about participating in a clinical research study for people who have gout. A clinical research study may be an option for you if you are concerned about suffering another gout attack. Please talk to the study doctor and nurse to learn more about the kinds of gout studies that are available and which one might be right for you.

To find out more and see if you may qualify for a gout study, you can call Jessie, Heather or Diane at CCRstudies in New London, CT.  Dr. Edward McDermott is the study doctor. Call: (860) 443-4567

About Gout

Gout is a type of arthritis. Gout is caused by high levels of uric acid in your blood (hyperuricemia) that form crystals your joints. People who have gout can go for many months or even years without having any symptoms, but suddenly start to feel pain, swelling and discomfort in the joints. These attacks are often called ‘flares’. The joint most often affected is the big toe.

Attacks can happen again, unless the gout is treated. If the uric acid is not properly controlled, gout can damage joints, tendons, and other tissues over time. Gout is more common in men, but the risk of gout for women becomes greater with menopause.

What causes gout?

Most people develop gout because the kidneys do not get rid of enough uric acid, the uric acid in the blood builds up, and crystals develop around the joints. This causes inflammation (swelling and redness) and severe pain of the joints.

A number of things can increase your risk of gout attacks:

• Family history (if your parents or grandparents had gout)
• Certain medical conditions or taking certain medications
• Being overweight
• Regularly drinking alcohol or sugary soda drinks
• Eating foods high in ‘purines’ which convert to uric acid in the blood. These foods include herring, anchovies, sardines, shellfish, red meat, liver and kidneys

What is the treatment for gout? 

Allopurinol and febuxostat are the most commonly prescribed medicines for the treatment of gout. They work by stopping the body from producing too much uric acid. This helps to reduce the frequency and severity of gout attacks. Lesinurad is an investigational medication currently being researched to determine how effective it is in treating gout. Lesinurad is an investigational medication currently being researched to determine how effective it is in treating gout. Lesinurad works differently than allopurinol and febuxostat by helping the kidneys

 What are some treatments for the pain, redness and swelling of gout attacks?

Colchicine: This can relieve pain during gout attacks and may also help to reduce swelling  and redness.

NSAIDS (anti-inflammatory pain relievers): Medicines such as naproxen, diclofenac and indomenthacin can be used to help relieve symptoms (pain and swelling) during a gout attack.

Who Can Participate in a Gout Study?

To participate in a gout study,  you must:

• Have a diagnosis of gout
• Be willing to take investigational medication daily
• Be willing to attend montly study visits, which will take place over 6 to 12 months, depending on the research study that is best for you.

The study doctor and nurse can explain all the study requirements to you.

Benefits of Study Participation

 As a study participant, you may receive:

• Investigational medication at no cost
• Study-related medical care and tests at no cost
• Close monitoring of your gout

You may also be provided compensation to cover your time and travel expenses.

You should know that:

• Your medical information is strictly confidential, unless given your permission or except as required by law

Clinical Research Studies and You

What every participant needs to know

Stay Involved, Ask Questions

As with any important health decision, it is important that you understand fully what is involved before deciding to take part in a clinical study. Make sure you read all of the information you are given, and ask a member of the study team if anything is not clear. You may also want to talk to your primary care physician or family doctor about whether ttaking part is right for you. The study team will also be able to talk to you about what other treatment otpions are available to you.

Understanding the Informed Consent Process

 ’Informed consent’ is a process that takes place before you join the study and is a legal requirement for all clinical research studies. As part of the process, a member of the study team will describe all of the possible risks and benefits of taking part in the study and what you will be expected to do as part of your participation. This process helps to protect the rights of people participating in research. Before signing the informed consent document, you will be encouraged to ask any questions you may have about the study. You will also be told about who will see your personal medical information, and how it will be kept confidential.

You Are In Control

If at any time during the study you decide that you no longer want to take part, you have the option to stop participating.

Keep Your Personal Physician Informed

If you qualify and consent to take part in this study, you may wish to tell your personal doctor tat you are volunteering for this clinical study. You may also wish to let your doctor know how long you will be involved int the study, and the name of the doctor(s) at the study center. Please ask a member of the study team if you would like them to talk to your doctor about the study and what is involved.

Two easy steps to see if you qualify

1. See if you pre-qualify by answering a few questions: Call (860) 443-4567, if the answers you give in response to the pre-screening questions show that you may qualify for a study, with your permission, your information will be forwarded to the study team at the research center you select during this process. Someone from the research center will then contact you and talk with you in more detail about the study.

2. Talk with the study doctor or nurse when they call you to confirm your information and schedule an appointment. As part of the screening process, the study doctor and other members of the study team will invite you to the clinic. At this screening visit, additional information about your general health, your gout, your medical history, and which medications you take for your gout attacks will be collected. Based on your answers to these and other questions, the study team will make the final determination of whether or not you are eligible to take part in the study.

To find out more and see if you may qualify, call CCRstudies in New London, CT at (860) 443-4567

SAIRB approved 12Apr2012 MA1203894