The ASCEND clinical research study is for people who have painful osteoarthritis of the knee (OA). The study will test an investigational OA knee treatment to learn if it can potentially provide long-lasting relief from pain and slow down its progression.
Study participants may be able to join the study if they meet the following requirements:
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45 to 80 years of age
Confirmed diagnosis of osteoarthritis of the knee
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Failed 2 or more therapies in the past 12 months (such as physical therapy, over-the-counter pain medication, etc.)
Experience consistent knee pain (every other day or more on average) for the past month.
Other study requirements will apply.
Participation in the ASCEND study lasts about lasts about 5 years. Study participants can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
The study drug, PCRX-201, is an investigational osteoarthritis knee treatment taken as an injection. It is designed to use the body’s own cells to reduce cartilage and bone inflammation in the knee that is causing knee pain.
PCRX-201 has been designed with a focus on potentially providing long-lasting pain relief and slowing the progression of knee OA.
Watch the video below to learn more about how the study drug is designed to work in the body.
Participants will be assigned at random to a study group to either receive the study drug or a placebo. Two out of every three participants will receive the study drug while the rest will receive a placebo.
Whether you are assigned to receive the study drug or a placebo, you make a positive impact in clinical research helping researchers identify if any health changes are from the study treatment or another source. You will receive care from experts who specialize in your condition no matter what group you are assigned.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like the ASCEND study.
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Knee osteoarthritis (OAK) is when the cushion between the bones, called cartilage, wears down over time. Without enough cushion, the bones start to rub against each other, which can cause knee joint pain/tenderness, decreased function, stiffness, and swelling.
The goal of the ASCEND study is to provide a potential solution for patients suffering from this condition that may be long-lasting, slows down progression, and doesn’t require surgery.
At this time, there is no progression-modifying treatment available for OA of the knee and its associated pain. Some subjects may live for decades with the disease. People living with OA of the knee may turn to pain relief options such as supplements, physical therapy, or knee replacement surgery.
The goal of the ASCEND study is to provide a potential solution for patients suffering from this condition that may be long-lasting, slows down progression, and doesn’t require surgery.
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical trial, take the pre-screener and a study team member will contact you if you pre-qualify.
Use the filters, map, and listing to find the study clinic closest to you.
If you are interested in joining the ASCEND study, take the short pre-screener to see if you may qualify.