A 5- year randomized, double-blind, placebo-controlled, multi-center study assessing the efficacy, safety, and tolerability of intra-articular regimens of LNA043 versus placebo in patients with symptomatic knee osteoarthritis (ONWARDS)
This 5-year study, called ONWARDS, is investigating a new treatment called LNA043 for people with painful knee osteoarthritis. Researchers want to see if LNA043 can improve the structure of the knee joint and help reduce pain and stiffness compared to a dummy treatment (placebo). The study will involve many people at different hospitals (multi-center) and neither the patients nor the doctors will know who is getting the real medicine or the placebo (double-blind). This helps to make the results fair and accurate. They will also check for any side effects. This is an early stage of research (Phase II) to explore if the treatment is promising.
At a glance
What is this study about?
This study is called ONWARDS and it's looking into a new treatment for knee osteoarthritis. Osteoarthritis is a common condition where the cartilage, the smooth tissue that covers the ends of bones in your joints, wears down over time, leading to pain, stiffness, and swelling. This particular study is focusing on knee osteoarthritis, which affects many people and can make everyday activities difficult.
The main goal of this study is to see if a new medicine, LNA043, can actually make a difference to the structure of the knee joint, meaning it could potentially slow down or even improve the wear and tear. They will also be closely watching to see if LNA043 helps with the symptoms of osteoarthritis, such as pain and how well people can move their knee. To make sure the results are reliable, some people will get the new medicine and others will get a placebo, which looks like the medicine but has no active ingredient. Neither the patients nor the doctors will know who is getting what, which is a standard way to get unbiased results.
Over the five years, the study will also carefully record any side effects that people experience. This is crucial for understanding whether the new medicine is safe to use. By comparing the new medication to a placebo and monitoring everything closely, researchers hope to learn whether LNA043 could be a helpful new option for people living with knee osteoarthritis.
Key takeaways
- This is a 5-year study for knee osteoarthritis.
- It tests a new medicine called LNA043 against a dummy treatment.
- Aims to see if LNA043 improves knee structure and reduces pain.
- Open to adults aged 18 and over with symptomatic knee osteoarthritis.
- Participation involves regular clinic visits, injections, and health checks.
Who may be eligible?
To join this study, you need to be at least 18 years old. There's no upper age limit, so older adults can also take part. The study is open to both men and women.
The most important thing is that you have been diagnosed with osteoarthritis in your knee and are experiencing symptoms from it, such as pain. The researchers will have specific ways to check if your knee osteoarthritis fits what they are looking for in terms of severity and type.
There will also be other medical checks to make sure the study medicine is safe for you. This might include reviewing your general health and any other medications you are taking, to ensure they don't interfere with the study medicine or your safety.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with osteoarthritis in your knee?
- Are you currently experiencing pain or other symptoms from your knee osteoarthritis?
- Are you able to attend regular clinic appointments for five years?
What does participation involve?
If you decide to take part in this study, it will last for five years. During this time, you will have regular visits to the clinic where you'll receive the study medicine, which will be given as an injection directly into your knee. You will either receive LNA043 or a placebo, but you won't know which one. These visits will also involve various assessments to see how your knee is responding to the treatment.
These assessments will include physical exams, questionnaires to track your pain and how well you can move (like the WOMAC pain and function scores), and imaging scans, such as X-rays or MRI, to look at the structure of your knee joint. You will also be asked about any side effects or changes you experience in your health.
Throughout the study, you'll have follow-up appointments to monitor your progress and safety. It's important to attend all scheduled visits and communicate any concerns you have with the study team.
Potential risks and benefits
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Common questions
What is knee osteoarthritis?
It's a condition where the protective cartilage in your knee joint wears down over time, causing pain, stiffness, and swelling.
What is LNA043?
LNA043 is a potential new medicine being tested to see if it can help improve knee osteoarthritis and reduce symptoms.
What does 'double-blind' mean?
It means neither you nor your study doctor will know if you're getting the active medicine or a dummy treatment (placebo), to keep results fair.
How long will the study last if I join?
This particular study is planned to last for a total of five years.
Can I stop participating in the study if I want to?
Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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