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Study on the Effects of Adalimumab and Saline in Patients Undergoing Needle Fasciotomy for Dupuytren's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Dupuytren's Disease, which affects the hands and can cause fingers to bend towards the palm. The study is investigating whether a medication called Adalimumab, which is an anti-TNF (tumor necrosis factor) treatment, can improve the results of a procedure called needle fasciotomy. This procedure is used to treat Dupuytren's Disease by cutting the thickened tissue in the palm to help straighten the fingers.

The purpose of the study is to see if using Adalimumab can lead to better outcomes for patients undergoing this procedure. Participants in the study will receive either the medication or a placebo, which is a substance with no active drug. The study will last for a period of time, during which participants will receive injections and be monitored for changes in their condition. The goal is to determine if there is an improvement in finger movement and overall satisfaction with the treatment.

Throughout the study, participants will be assessed on various factors, including the degree of finger straightening, recurrence of the condition, pain levels, and overall satisfaction with the treatment. The study aims to provide valuable information on whether Adalimumab can be an effective addition to the treatment of Dupuytren's Disease when combined with needle fasciotomy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide voluntary written informed consent. This means you agree to participate after understanding the study details.
You must be at least 18 years old and diagnosed with Dupuytren disease. You should be eligible for a procedure called fasciotomy, which involves cutting the thickened tissue in your hand.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes checking if you have joint contractures that are not fixed and a diathesis score of at least 4.
Step 3
Treatment allocation
You will be randomly assigned to receive either the medication adalimumab or a placebo (saline).
Both adalimumab and saline will be administered through injection.
Step 4
Medication administration
The medication or placebo will be given according to the study schedule. The exact dosage and frequency will be explained to you by the study team.
Step 5
Monitoring and follow-up
Throughout the study, your progress will be monitored. This includes measuring the correction of finger extension, recurrence rate, and pain levels using a visual analogue scale.
Your satisfaction with the treatment will also be assessed using a visual analogue scale.
Step 6
Completion of the study
The study is expected to end by March 18, 2025. Upon completion, the results will be analyzed to determine the effectiveness of the treatment.

Who can join the trial?

5 criteria

The participant or their legally authorized representative must provide voluntary written informed consent before any screening procedures. This means they agree to join the study after understanding what it involves.
Participants must be 18 years old or older and have been diagnosed with Dupuytren disease.
Participants must be eligible for a procedure called fasciotomy, which is a type of surgery to treat Dupuytren disease.
Participants must have joint contractures in the MCP/PIP joints that are not fixed. This means the joints in the fingers are bent but can still be moved.
Participants must have a diathesis score of at least 4. This score is a measure used by doctors to assess the severity of Dupuytren disease.

Who cannot join the trial?

4 criteria

Patients who are not within the specified age range for the study.
Patients who have medical conditions other than Dupuytren Disease.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who are not eligible for the specific treatment being studied, which involves an anti-TNF medication. This is a type of drug that helps reduce inflammation in the body.

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Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

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Investigated drugs

Adalimumab is a medication used in this clinical trial to see if it can help improve the results of a procedure called needle fasciotomy for people with Dupuytren disease. Dupuytren disease is a condition where the fingers bend towards the palm and cannot be fully straightened. Adalimumab works by blocking a substance in the body that causes inflammation, which might help reduce the symptoms and improve hand function after the procedure.

What is already known about the treatment

Adalimumab – Adalimumab is administered as an injection under the skin, typically in the thigh or abdomen. It is currently being studied in clinical trials to assess its effectiveness in improving outcomes for patients undergoing needle fasciotomy for Dupuytren disease, a condition that affects the hands. The main therapeutic indication for Adalimumab in this trial is to reduce inflammation and improve hand function in patients with Dupuytren disease. At the molecular level, Adalimumab works by blocking a protein called tumor necrosis factor (TNF), which plays a role in inflammation. It is classified as a biologic medication, specifically an anti-TNF agent.

Investigated diseases

Dupuytren Disease – Dupuytren Disease is a condition that affects the connective tissue under the skin of the palm and fingers. It progresses slowly, often starting with small lumps or nodules in the palm. Over time, these nodules can thicken and contract, forming cords of tissue that can pull one or more fingers into a bent position. This bending, known as contracture, can make it difficult to fully straighten the affected fingers. The disease typically affects the ring and little fingers and is more common in older adults. The progression can vary, with some individuals experiencing mild symptoms and others developing significant contractures.