This clinical research study is testing the safety and effectiveness of a new investigational medication for qualified individuals.
You may be eligible to participate if you are 40-80 years old and have been diagnosed with moderate to severe Osteoarthritis of the Knee.
There are additional study requirements to participate. A study representative will discuss them with you.
The STRIDES-1 study is testing the safety and effectiveness of a new investigational medication, in comparison to a placebo, administered as a single injection in the knee. Qualified individuals will have the option to participate in a 28-week study, with approximately 6 in-person visits and 3 telephone visits.
Approximately half the subjects in the study will receive placebo, meaning that you have a 50:50 chance of receiving placebo. The study treatment that you receive for the study will be selected at random, similar to flipping a coin. A placebo is often similar in appearance to the active study drug but does not have any active ingredients or contain the study drug. In this study, the placebo does not contain active study drug or active ingredients but is different in appearance from the active study drug. Therefore, you will not be allowed to see the injection that you receive for the study so that you will not know what you receive.
Are there benefits to taking part in this study?
Taking part in this study may or may not make your osteoarthritis better. The study drug may make your health better, worse, or the same as other treatments that are available. Information from this study may help doctors learn more about treatments for your condition and this information may help other subjects, even if it may not help you.
What is Osteoarthritis?
Osteoarthritis (OA) is the most common form of arthritis, and the major cause of activity limitation and physical disability. Today, 35 million people (13% of the US population) are 65 and older, and more than half of them have radiological evidence of OA in at least 1 joint.
Common symptoms may include:
A clinical research study tests the safety and effectiveness of a new medication or treatment in a population of volunteers. All new drug products go through the clinical trial process, therefore, participants like you play a very important role in advancing medicine for present and future generations.
An experimental investigational medication is a medication that has not been approved by the US Food and Drug Administration (FDA) but can be administered to people for research purposes.
A placebo is often similar in appearance to the active study drug but does not have any active ingredients or contain the study drug. In this study, the placebo does not contain active study drug or active ingredients but is different in appearance from the active study drug. Therefore, you will not be allowed to see the injection that you receive for the study so that you will not know what you receive.
Your participation in this study is voluntary. You can decide to stop at any time, and you may still be treated at the facility. Your decision whether to take part in the study will not affect your current or future care at the facility.
If you are found to be eligible for the study, you may be contacted by phone or email to confirm administrative or timing details that are described in this consent. For your own safety, you are asked to follow, without exception, the rules and instructions provided to you. If you do not follow these rules and instructions, you may be withdrawn from the study.
In order to provide maximum protection for your health, the study will be under the direct supervision of the study doctor and will be conducted by trained personnel. Please provide us with all the information about your current and past health (medical history) at the Screening Visit and at each Follow-up Visit, including participation in any other trials. We need this information to protect your health.
It is desirable that your personal doctor be advised of your decision to participate in this research study. If you have a personal doctor, it is strongly recommended that you inform him/her of your involvement in this research study.
Tell your study doctor if you are thinking about stopping or decide to stop. You should talk to the study doctor about leaving the study before you decide so that he/she can find out if you are having any side effects from study treatment, and he/she can tell you how to stop safely. Because this study only requires a single injection on Day 1, it is not expected that there will be any harm to your well-being (e.g., withdrawal symptoms) if you decide to stop. Another reason to tell the study doctor that you are thinking about stopping is so that he/she can talk to you about any other treatments, follow-up care, and/or testing that could be helpful to you.
If you decide to stop participating in this study, you will still be asked to come back to the research site for an Early Termination Visit. The procedures that will be done for this visit will include those procedures described in the Early Termination Visit section. This information is important to make sure that there are no lasting side effects from the study treatment and to see if your disease got better, stayed the same, or got worse after treatment.
Current study locations are listed below and more may be added at any time. If you are interested in participating in the STRIDES-1 study, complete the form to speak with a study representative regarding your eligibility and available study locations.
To share this study information use the links below.