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RADIUS-8 is a clinical research study for adults with continuing active rheumatoid arthritis (RA) symptoms.
Why is the RADIUS-8 clinical research study being done?
The purpose of this clinical research study is to see if MK-8457, the study drug, is safe and effective and how well people with RA tolerate it when it’s taken in combination with methotrexate (MTX).
What are the study drugs?
MTX is available by prescription for the treatment of RA.
MK-8457, the study drug, is considered investigational in this study because it has not yet been approved for patients with RA. MK-8457 blocks a protein in the body that doctors believe may play a part in causing the inflammation associated with RA.
Some participants will receive placebo; a placebo looks like the study drug but contains no active ingredients.
All study drugs will be given as pills that will be taken orally.
How long will the RADIUS-8 clinical research study last?
There are two parts to the study—the base study and the safety extension. If you are eligible for the study, your participation will last approximately two years, during which time you will need to visit the study clinic up to 20 times.
What will I be asked to do?
If you take part in the study, you will need to:
- Visit the study doctor about 20 times
- Have procedures to check your health, including physical exams, blood and urine tests, and electrocardiograms (ECGs) to monitor your heartbeat
- Take the study drugs by mouth as instructed
- Report any changes in your health and any side effects you may be experiencing
- Complete study questionnaires
There are other study requirements that the doctor will discuss with you if you are interested in participating.
Who can participate?
You may be eligible to participate in the RADIUS-8 clinical research study if you:
- Are 18 years of age or older
- Have had RA with active symptoms for at least the past 6 months
- Have been treated with MTX for at least the past 3 months
- Have not been exposed to RA medications that require injections or infusions other than corticosteroids
There are other requirements to be in the study that the study doctor or staff will discuss with you.
Study participation is voluntary. You do not have to participate in the RADIUS-8 clinical research study to receive treatment for your RA. If you do choose to participate, you may leave the study at any time for any reason.
All qualified participants will receive, at no charge, the study drugs and study-related tests and procedures.
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