Looking at the ACTEMRA Clinical Trials

In a clinical trial, up to half of the people taking ACTEMRA plus methotrexate experienced fewer RA signs and symptoms at 6 months.

In clinical trials, some people on ACTEMRA experienced improvement in their signs and symptoms of rheumatoid arthritis (RA) as early as 2 to 4 weeks after beginning therapy. These improvements could have included a decrease in pain and in their number of tender or swollen joints.

Serious Infections

Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.

What is a clinical trial?

We all have read articles that say a drug has been approved by the Food and Drug Administration (FDA) after successfully being tested in clinical trials. But knowing the exact significance of this can be confusing, especially with a disease like rheumatoid arthritis (RA) where there are so many different treatments and studies.

Before a medicine is approved by the United States Food and Drug Administration (FDA), scientific studies must be done. These studies may be called a clinical trial, clinical study, or clinical protocol. These terms all mean the same thing. They refer to the drug being tested in people who have the disease that the drug is intended to treat.

In some clinical trials, the new drug is compared to a placebo, which is an inactive substance made to look exactly like the medicine being tested. In other clinical studies, the drug is compared to a medicine that has already been approved to treat the disease.

Before a clinical trial begins, the people who will conduct the study discuss with the FDA the best way to test the new drug.

What is meant by signs and symptoms of RA?

Signs and symptoms are two words often used together. In medicine, signs refer to specific evidence of a disease such as the laboratory results or swelling in a joint. Signs are objective. Symptoms are feelings or experiences of the patient. They are subjective. Stiffness, joint pain and tenderness are common symptoms of RA.

The signs and symptoms of RA vary from individual to individual. These symptoms may last for only a few months, a year or two or a lifetime. Long-lasting disease holds the potential to cause serious, irreversible joint damage. This makes it important to treat its effects and not ignore them.

Doctors don't know exactly what causes the signs and symptoms of RA, but many medications are used to treat it. Some medications are used to treat the stiffness, pain or swelling. Other medications treat what is happening in the immune system, which is thought to be the root cause of RA.

Read the Medication Guide and talk to your doctor before you start ACTEMRA and before each infusion, because there may be new information. The Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

How was ACTEMRA tested?

The safety of ACTEMRA was tested in 5 different clinical studies that included more than 4000 people with RA.

These studies tested ACTEMRA at two different doses, 4 mg/kg and 8 mg/kg, given by intravenous (IV) infusion. The recommended starting dose is 4 mg/kg. Your doctor may decide to increase your dose to 8mg/kg based on how well the treatment is working for you.

Changes in certain laboratory test results

Your healthcare provider should do blood tests before you start receiving ACTEMRA and every 4 to 8 weeks for rheumatoid arthritis and 2 to 4 weeks for systemic JIA during treatment to check for the following side effects of ACTEMRA:

• low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections.
• low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
• increase in certain liver function tests. You should not receive ACTEMRA if your neutrophil or platelet counts are too low or your liver function tests are too high.

Your healthcare provider may stop your ACTEMRA treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results.

You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving ACTEMRA, and then every 6 months after that. Normal cholesterol levels are important to good heart health.

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