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Study on Infliximab and Azathioprine for Treating Complex Anal Fistulas in Patients Without Crohn'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 the treatment of anal fistulas, which are abnormal connections that can form between the end of the bowel and the skin near the anus. The study is investigating the use of a medication called infliximab, which is given as an infusion, to see if it can help improve the condition when used alongside standard surgical treatments. The trial also involves the use of azathioprine, a medication taken orally in tablet form, and saline, which is used in the infusion process. A placebo is also part of the study to help compare the effects of the treatments.

The purpose of the study is to explore how effective infliximab is when added to the usual surgical treatment for complex anal fistulas that are not related to Crohn's disease. Participants in the study will receive treatment over a period of time, and their progress will be monitored to see if the fistulas improve enough to allow for surgical closure. The study will also look at changes in the activity of the fistulas and any complications that might arise from the medical treatment.

Throughout the study, participants will undergo regular assessments, including evaluations of their quality of life and the activity of the fistulas using methods like MRI scans. The study aims to gather information over several months to determine the long-term effectiveness of the treatment and to see if it can lead to healing of the fistulas. The ultimate goal is to find a more effective way to manage and treat complex anal fistulas, improving the quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be informed about the study's purpose, procedures, and your role as a participant. You will be asked to provide consent to participate in the study.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and ensuring you meet the criteria for participation, such as having a complex anal fistula and not being diagnosed with Crohn's disease.
Step 3
Treatment phase
During the treatment phase, you will receive infliximab through an infusion. The frequency and dosage will be determined by the study protocol and your healthcare provider.
You may also receive azathioprine for oral use, depending on the specific requirements of the trial.
Step 4
Follow-up assessments
Regular follow-up assessments will be conducted to monitor your progress. These assessments may include physical examinations, imaging tests like MRI, and evaluations of your quality of life.
The primary goal is to observe any improvement in your condition, particularly the healing of the fistula, over a period of up to 30 months.
Step 5
End of trial
At the end of the trial, a final assessment will be conducted to evaluate the overall effectiveness of the treatment. This will include a review of any changes in your condition and any side effects experienced during the trial.

Who can join the trial?

5 criteria

Have a complex anal fistula. This means a type of tunnel that forms between the inside of the anus and the skin outside, which has not healed despite treatment for at least 6 months.
Do not have Crohn's disease. This is a condition that causes inflammation in the digestive system. You must have had normal results from specific tests in the last 6 months, including a camera test of the large intestine and small bowel, and no specific findings in tissue samples.
Be between the ages of 18 and 65 years old.
Speak and understand Danish.
Have received standard surgical treatment for the fistula, which includes repeated cleaning and a procedure called seton placement, for at least 6 months.

Who cannot join the trial?

10 criteria

Patients with any other significant health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent surgery unrelated to the anal fistula.
Patients who are currently participating in another clinical trial.
Patients with a known allergy to the study medication.
Patients who have a history of not following medical advice or treatment plans.
Patients with a compromised immune system, which means their body's defense against infections is weakened.
Patients who have a history of drug or alcohol abuse.
Patients with severe liver or kidney disease.
Patients who have been diagnosed with cancer in the past five years.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Bispebjerg Hospital
Verified
Copenhagen, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark

Trial locations

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Investigated drugs

Infliximab is a medication used in this clinical trial. It is a type of drug known as a biologic, which means it is made from living cells. Infliximab works by blocking a protein in the body called tumor necrosis factor-alpha (TNFα). This protein is involved in causing inflammation, which can lead to various health issues. In this trial, Infliximab is being tested to see if it can help reduce inflammation and improve healing in patients with complex anal fistulas, which are abnormal connections between the anal canal and the skin near the anus. The goal is to see if adding Infliximab to the standard surgical treatment can make the treatment more effective.

What is already known about the treatment

Infliximab – Infliximab is administered through an intravenous infusion, meaning it is given directly into a vein. It is currently being studied for its effectiveness in treating anal fistulas that are not related to Crohn's disease. The main therapeutic use of infliximab in this context is to help heal complex anal fistulas when used alongside standard surgical treatment. At the molecular level, infliximab works by blocking a protein called tumor necrosis factor-alpha (TNFα), which plays a role in inflammation. It is classified as a biologic medication, specifically an anti-TNFα agent.

Investigated diseases

Anal fistula – An anal fistula is an abnormal connection between the epithelialized surface of the anal canal and the perianal skin. It often results from an infection in the anal glands, which can lead to an abscess. Over time, the abscess may drain spontaneously or be surgically opened, creating a fistula. The condition can cause discomfort, pain, and discharge of pus or blood. It may progress with recurrent infections and inflammation, leading to chronic symptoms. The fistula can vary in complexity, with some being simple and others involving multiple tracts or branches.