What is the EXPLORE research study?
There is a need to develop additional medications for people with difficult-to-treat RA. In the EXPLORE research study, doctors and researchers want to evaluate an investigational treatment when it is given to adults with difficult-to-treat RA. The goal of the EXPLORE research study is to learn more about the safety and effectiveness of an investigational treatment, compared to placebo, which looks like the investigational treatment but contains no active medicine.
The investigational treatment is not approved by any regulatory health agency to treat RA. It is only available to people with RA in research studies like this one.
The results of this research study may help doctors and researchers better understand how the investigational treatment affects adults with difficult-to-treat RA.
Who is eligible to participate in this research study?
To pre-qualify for this study, you must:
Be 18 years of age or older
Have been diagnosed with RA
Have 6 or more tender joints and 6 or more swollen joints
Have not responded well to 2-3 medications for your RA
Please note that additional criteria apply. The study doctor/staff can help you understand which criteria you need to meet to qualify for this study.
All study-related visits, tests, and treatments will be provided at no cost. You may also be reimbursed for study-related travel expenses.
Click on the button to see if you qualify
What will happen during this research study?
If you are eligible and agree to participate, you will begin the study in Study Treatment Period 1. This period will last 16 weeks (4 months), and you will receive weekly injections of the investigational treatment.
If you complete Period 1 and meet certain criteria, you will begin Study Treatment Period 2. In this period, you will be randomly assigned (like flipping a coin) to receive weekly injections of the investigational treatment or placebo (which looks like the investigational treatment but contains no active medicine) for 12 weeks.
You have a 66.7% (2 in 3) chance of receiving the investigational treatment, and a 33.3% (1 in 3) chance of receiving placebo. You and the study doctor/staff will not know which study treatment (investigational or placebo) you are receiving. However, in the event of an emergency, this information can be provided.
If you complete Study Treatment Period 2, you may have the option to enter a 48-week extension period (Period 3).
Throughout the study, you may have the option to receive some injections at home. The study doctor/staff will talk with you more about this.
You will also be asked to attend regularly scheduled study clinic visits for health exams and tests to evaluate your health. Your total study participation, including Period 3, may last up to 85 weeks (approximately 20 months).