The Efficacy and Safety Study of 2107 Injection in Subjects With Mild to Moderate Knee Osteoarthritis
Researchers are looking for people aged 40-80 with mild to moderate knee arthritis to take part in a 26-week study. This study is testing a new injection called 2107 against a treatment already in use, DUROLANE®. Both treatments aim to help reduce knee pain. Participants will receive one injection in their affected knee and will be followed up over 26 weeks to see how well the treatment works and if there are any side effects. The study is 'double-blinded', meaning neither you nor your doctor will know which injection you're receiving, which helps make the results fair and unbiased. Your participation could help improve future treatments for knee arthritis.
At a glance
What is this study about?
This study is about finding better ways to help people with knee osteoarthritis, which is a common condition causing pain and stiffness in the knee joints. Researchers are testing a new injection, called 2107, to see how well it works compared to a treatment that's already available, called DUROLANE®. Both of these treatments are designed to be given directly into the knee joint.
We need about 286 volunteers with mild to moderate knee osteoarthritis to take part. The study will last for 26 weeks (about six months). During this time, we will carefully check if the 2107 injection is good at reducing pain and if it has any side effects, comparing it directly to DUROLANE®.
One important aspect of this study is that it's 'double-blinded'. This means that neither you nor your study doctor will know which of the two injections you've received. This helps make sure the results are as fair and unbiased as possible, so we can get a true understanding of how effective and safe the new treatment is.
Key takeaways
- This study is testing a new knee arthritis injection against an existing one.
- It's for people aged 40-80 with mild to moderate knee arthritis.
- You'll get one injection and have follow-up visits over 26 weeks.
- Neither you nor your doctor will know which treatment you receive.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you should be an outpatient between 40 and 80 years old, male or female. You need to have been diagnosed with mild to moderate knee arthritis for at least six months, and this diagnosis needs to be confirmed by X-rays from the last year. Your treated knee should have a pain score between 40 and 80 on a special pain scale, and you should have daily pain despite trying other treatments like physiotherapy or painkillers for over two weeks.
Before you start, you'll need to stop taking any painkillers for at least 72 hours, or longer depending on the specific painkiller. You also need to be able to understand and sign a consent form, confirming you want to take part.
However, you can't join if you have other types of arthritis like rheumatoid arthritis, gout, or other serious joint conditions. You also can't take part if you've had an allergic reaction to similar substances before, or if you have an infection or skin problem in the knee being treated.
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 between 40 and 80 years old?
- Do you have a confirmed diagnosis of mild to moderate knee arthritis?
- Have you had daily knee pain for more than two weeks, despite other treatments?
- Are you able to stop taking painkillers for at least 72 hours before starting?
- Do you NOT have other serious joint conditions like rheumatoid arthritis or an infection in your knee?
What does participation involve?
If you join this study, you'll be randomly assigned to receive either the new 2107 injection or the DUROLANE® injection. This will be a single injection given into one of your knees that has arthritis. You won't know which injection you receive, nor will your study doctor.
The study will involve six visits to the clinic over a 26-week period (about six months) after your injection. During these visits, the study team will carry out various checks to see how your knee pain is, if your knee swelling or tenderness has changed, and to look for any side effects. You'll also be asked about any other medications you take. If you decide to leave the study early, there will be a final check-up visit.
Potential risks and benefits
Locations (3)
- CenterMed Krakow Sp. z o.o.Verified postcodeKrakow, Poland
- Corporació Sanitària Parc TaulíVerified postcodeSabadell, Spain
- NHS Greater Glasgow and ClydeVerified postcodeGlasgow, United Kingdom
Common questions
What is knee osteoarthritis?
It's a common condition where the cartilage cushioning your knee joint wears down, leading to pain, stiffness, and sometimes swelling.
What is an intra-articular injection?
It means the medicine is injected directly into your knee joint, aiming to deliver the treatment right where it's needed.
Will I know which treatment I'm getting?
No, neither you nor your doctor will know if you're receiving the new 2107 injection or DUROLANE®. This is standard practice in trials to ensure fair results.
How long will the study last for me?
The study will follow you for 26 weeks, which is about six months, after you receive the single injection.
What if I feel worse during the study?
Your safety is a top priority. You'll be closely monitored, and you should always tell the study team about any changes in your health or if you feel unwell.
How to find out more
Lingyu Pan
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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