Study on Infliximab and Azathioprine for Treating Complex Anal Fistulas in Patients Without Crohn’s Disease

2 1 1

What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bispebjerg Hospital	Copenhagen	Denmark

Other Sites

Site Name	City	Country	Status
Region Midtjylland	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.12.2022

Trial locations

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.

Investigated diseases:

Anal fistula

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.

Trial ID:

2022-502263-38-00

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Infliximab and Azathioprine for Treating Complex Anal Fistulas in Patients Without Crohn’s Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?