About the REDUCE Studies

The REDUCE Studies | inflamed foot
The REDUCE Studies | inflamed foot
The REDUCE Studies | inflamed foot
The REDUCE Studies | inflamed foot

What are the REDUCE Studies?

Gout is a form of arthritis (a disease that affects joints). It happens when the body has too much uric acid. This extra uric acid forms into crystals that build around and settle in the joints. The build-up of uric acid causes attacks (also called flares) of painful and swollen joints, and tophi.

The REDUCE Studies are researching a potential new medication (study drug) to see how safe it is and whether it works to reduce gout flares in people with gout, with or without tophi (swollen growths around joints). The study drug will be compared with a placebo, which looks the same as the study drug but contains no active medication.

There is a need for a new and safer drug to manage high levels of uric acid for patients with gout. This is because the gout treatments that are currently available have drawbacks. Some currently available medications:

  • cannot be used by patients with other conditions
  • are only given in hospital
  • do not always work well enough when given alone
  • may cause side effects, so patients need careful monitoring.

The study drug in the REDUCE Studies is a capsule that will be taken by mouth once daily. The aim of the studies is to find out if the study drug can reduce gout-causing uric acid and improve patients’ quality of life.

Approximately 1500 people from all over the world will take part in the REDUCE Studies.

What to expect

If you are eligible to take part, you will be in 1 of the REDUCE Studies for about 14 months and will have up to 10 study center visits. On some occasions, you may also need to speak to the study team over the phone.

If you take part, the study team will perform tests and assessments to monitor your health throughout the study. These will include:

  • asking questions about your health, including recording your alcohol and tobacco use
  • conducting physical examinations
  • measuring your vital signs (blood pressure, heart rate, breathing rate, and temperature)
  • checking your gout symptoms
  • performing electrocardiograms
  • collecting blood and urine samples to check for infections (such as HIV and hepatitis B and C) and the amount of uric acid in your blood
  • checking whether you have any side effects.

The study periods

Each of the REDUCE Studies is split into 3 periods:

1

Screening period

(up to 6 weeks)

  • You will visit the study center up to 2 times to see whether the study is right for you and to give you preventive medicine before you start the study treatment.

2

Study treatment period

(about 12 months)

  • You will visit the study center 7 times for study assessments. You will take 1 capsule of study medication (either the study drug or a placebo) once a day.

3

Follow-up period

  • You will visit the study center 1 time about 2 weeks after your Month 12 visit for study assessments.