A single-arm, open-label, Phase III trial to evaluate the safety and tolerability of intra-articular injections of RTX-GRT7039 in subjects with moderate to severe pain associated with osteoarthritis of the knee.
This research study is testing a new injectable medicine called RTX-GRT7039 for people who have moderate to severe knee pain due to osteoarthritis. It's an important part of developing new treatments and focuses on safety. Researchers want to see if the injection causes any side effects, especially those that might lead someone to stop participating in the study. They will also look at whether the injection affects the knee joint itself, how it impacts pain and physical abilities, and overall quality of life. This study is for adults aged 18 and over, regardless of gender, who are experiencing significant knee pain from osteoarthritis.
At a glance
What is this study about?
This study is about a new treatment for knee osteoarthritis, which is a common condition where the cartilage in your knee joint wears down, causing pain, stiffness, and swelling. If you have moderate to severe pain in your knee because of osteoarthritis, this study might be relevant to you. The new treatment being tested is an injection called RTX-GRT7039, which is given directly into the knee joint. This type of study, called a Phase III trial, is a crucial step before a new medicine can be considered for wider use.
The main goal of this particular study is to understand how safe the RTX-GRT7039 injection is. Researchers will carefully track any side effects that people experience after receiving the injection. They are especially interested in side effects that are serious or uncomfortable enough to make someone decide to leave the study. Understanding the safety profile of a new treatment is always the top priority.
Besides safety, the study will also look at how effective the injection might be. This includes checking if the injection causes any changes to the knee joint itself, which will be looked at using X-rays or MRI scans. Researchers will also measure changes in knee pain and how well people can move their knee using special questionnaires. Finally, they'll assess how the treatment affects a person's general quality of life. This comprehensive approach helps researchers get a full picture of the new treatment.
Key takeaways
- Tests a new knee injection for osteoarthritis pain.
- Focuses most on safety and potential side effects.
- Also checks effects on pain, movement, and quality of life.
- Open to adults aged 18+ with moderate to severe knee osteoarthritis pain.
- Involves clinic visits, questionnaires, and possibly scans.
Who may be eligible?
To be part of this study, you must be 18 years old or older. The study is open to both men and women.
The most important health condition for this study is having moderate to severe knee pain caused by osteoarthritis. If your pain is mild, or if your knee pain is due to something else other than osteoarthritis, this study might not be suitable for you.
There might be other specific health requirements or conditions that could prevent you from joining, which the study team will discuss with you. These are put in place to ensure your safety and the accuracy of the study results.
- Are you 18 years old or older?
- Do you have knee pain that your doctor has diagnosed as osteoarthritis?
- Is your knee pain moderate to severe?
- Are you comfortable receiving injections into your knee joint?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive the investigational injection, RTX-GRT7039, directly into your knee joint. For comfort during the injection, you may also receive a local anaesthetic called Naropin®. The study will involve several visits to the clinic so the research team can monitor your health, check for any side effects, and assess how the treatment is affecting you.
During these visits, you'll likely have physical examinations, blood tests, and complete questionnaires about your pain, physical abilities, and quality of life. You may also have imaging tests like X-rays or MRI scans of your knee to see if there are any changes to the joint. The entire study will last for a set period, and the research team will explain the full schedule of visits and procedures to you before you make any decisions.
Potential risks and benefits
Locations (3)
- —Romania
- —Bulgaria
- —Poland
Common questions
What is osteoarthritis of the knee?
Osteoarthritis is a common type of arthritis where the protective cartilage on the ends of your bones wears down over time, causing pain and stiffness in your knee joints.
What is RTX-GRT7039?
RTX-GRT7039 is the name of the new medicine being tested in this study. It's an injection designed to be given directly into the knee joint to help with osteoarthritis pain.
What does 'Phase III trial' mean?
A Phase III trial is a later stage of research where a new medicine is tested on a larger group of people to confirm its safety and effectiveness before it can be considered for general use.
Will I know if I'm getting the actual study drug?
This is an 'open-label' study, which means both you and the study team will know that you are receiving the RTX-GRT7039 injection.
What are 'side effects'?
Side effects are any unwanted or unexpected reactions that can happen after taking a medicine or having a treatment. The study carefully tracks all of these.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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