Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Pilot study RCT anti-NGF Adalimumab versus placebo in fasciotomy Dupuytren contracture

This research study is looking into a condition called Dupuytren's disease, which causes fingers to bend towards the palm. Scientists are testing a medicine called Adalimumab against a dummy treatment (placebo) in people who have already had surgery to help their fingers. The main aim is to see if Adalimumab can help straighten fingers by at least 10 degrees more than the dummy treatment. This is a "Phase III" study, which means it's a larger study to confirm if the new treatment works and is safe before it might be made available more widely. Researchers will also be checking for how often the problem comes back, how much pain people feel, and how happy they are with their hand's improvement.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

UZ Leuven

Enrolment target

Start

05 Jul 2023

Dupuytren Disease

What is this study about?

Imagine your finger or fingers start to bend into your palm, and you can't straighten them out properly. This is what happens with Dupuytren's disease. It's caused by a thickening of the tissue under the skin in your palm. Sometimes, surgery can help to release these tight tissues and improve finger movement.

This study is for people who have already had surgery for Dupuytren's disease. Researchers are testing a medicine called Adalimumab. They want to find out if this medicine, given after surgery, can help to keep your fingers straighter and prevent the condition from getting worse again compared to people who receive a dummy treatment (a placebo).

The main thing the researchers are looking for is whether Adalimumab can improve the straightening of your fingers by at least 10 degrees more than the dummy treatment. They will also be tracking other important things like how much pain you might have, how well you can use your hand in daily life, and how satisfied you are with your treatment. This is a "Phase III" study, meaning it's a very important step to confirm if the treatment is effective and safe.

Key takeaways

This study investigates if Adalimumab can help straighten fingers better after Dupuytren's surgery.
It aims to improve finger movement by at least 10 degrees more than a dummy treatment.
You might receive either the active medicine or a placebo, and neither you nor your doctor will know which.
Your finger movement, pain, hand function, and satisfaction will be regularly checked.
Being an adult (18+) with Dupuytren's and having had recent finger surgery are key requirements.

Who may be eligible?

To be able to take part in this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you would need to have Dupuytren's disease and have recently had an operation on your hand to help straighten your fingers. The research team will have specific medical criteria to decide if this study is suitable for you.

It's important to discuss with your doctor if you meet these general requirements and if the study sounds like it could be a good fit for your specific health situation.

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?
Do you have Dupuytren's disease?
Have you recently had surgery on your hand for Dupuytren's disease?
Are you able to attend regular clinic appointments?
Are you open to potentially receiving a placebo (dummy treatment)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the study medicine, Adalimumab, or a dummy treatment (saline, which is just saltwater). You wouldn't know which one you are getting, and neither would your study doctor. This is called a 'blinded' study, and it helps to make sure the results are fair.

Your involvement would include several visits to the clinic where the study team would carefully check your hand, measure your finger movement, and ask you questions about your pain and how your hand is affecting your daily life. They will use special forms and scales, like a 'Visual Analogue Scale' for pain, which involves indicating your pain level on a line. They will also track how satisfied you are with your treatment.

Details about the total length of the study, how often you would need to visit, and any follow-up appointments will be fully explained by the research team if you are deemed suitable.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as helping your fingers stay straighter after surgery and potentially reducing the chance of your Dupuytren's disease coming back. However, there's also a chance you might receive the dummy treatment and not experience these direct benefits from the study medicine. As with any medicine, Adalimumab can have side effects, and some risks are involved. The research team will explain all known potential side effects and risks associated with Adalimumab and with taking part in the study so you can make an informed decision. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is Dupuytren's disease?

It's a common hand condition where lumps of tissue form under the skin in your palm, which can eventually cause your fingers to curl inwards and make it hard to straighten them.

What is Adalimumab?

Adalimumab is a medicine that works by calming down parts of the body's immune system. It's used for several conditions, and in this study, researchers are exploring if it can help with Dupuytren's disease.

What does 'placebo' mean?

A placebo is a dummy treatment, like a saltwater injection, that looks exactly like the real medicine but contains no active drug. It helps researchers compare the real medicine's effects fairly.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know. This is a common practice in research called 'blinding' to ensure the study results are as accurate and unbiased as possible.

What does a 'Phase III' study mean?

Phase III studies are usually larger studies that aim to confirm if a new treatment is effective and safe. If successful, it's a big step towards the medicine potentially becoming widely available.