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Study on Stopping Infliximab, Methotrexate, and Azathioprine in Patients with Sarcoidosis in Remission

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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 condition known as sarcoidosis, which is a disorder affecting the immune system. The study is evaluating the effects of stopping a treatment with a medication called infliximab, which is used to manage this condition. Infliximab is a type of medication known as a TNF-alpha antagonist, which helps reduce inflammation in the body. The purpose of the study is to compare two different strategies for maintaining remission, which means keeping the disease inactive, in patients who have already achieved remission after being treated with infliximab.

Participants in the study will be divided into groups to test these strategies. Some participants will continue with their current treatment, while others will stop taking infliximab. The study will monitor the participants over a period of time to see how many experience a major relapse, which is when the disease becomes active again. This will help researchers understand the best way to manage sarcoidosis after initial treatment with infliximab.

In addition to infliximab, the study also involves other medications such as methotrexate and azathioprine, which are taken in tablet form. Methotrexate is a chemical substance used to treat various immune system disorders, while azathioprine is another medication that helps suppress the immune system to prevent it from attacking the body. The study will last for up to 12 months, and participants will receive either the medication or a placebo during this time. The results will provide valuable information on how to best maintain remission in patients with sarcoidosis.

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 study
Upon joining the study, you will be required to provide a signed informed consent. This document confirms your understanding and agreement to participate in the trial.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are at least 18 years old, affiliated with the National French social security system, and have a clinical and radiological presentation consistent with sarcoidosis.
Your medical history will be reviewed to ensure the presence of non-caseating granulomas in at least one organ and to exclude other causes of granulomas.
It will be confirmed that you have been on infliximab treatment for at least 6 months and that your steroid dosage has been less than or equal to 10 mg per day for at least 6 months.
Your disease activity will be assessed to ensure no activity (ePOST score 0) for at least 6 months, along with normal ACE and serum calcium levels.
Step 3
Treatment phase
During the treatment phase, you will continue with your current medication regimen. This includes the administration of infliximab intravenously, which you have been receiving for at least 6 months.
You will also continue taking methotrexate and azathioprine orally as prescribed by your healthcare provider.
Step 4
Monitoring and follow-up
Regular monitoring will be conducted to assess your health status and the effectiveness of the treatment. This includes routine check-ups and tests as determined by the study protocol.
The primary focus will be on evaluating the percentage of patients experiencing major relapses in the two groups being studied.
Step 5
Completion of the study
The study is expected to continue until February 7, 2026. Upon completion, you will undergo a final assessment to evaluate your health status and any changes observed during the trial.

Who can join the trial?

10 criteria

Must be 18 years or older.
Must be part of the National French social security system.
Must have a clinical and radiological presentation that matches sarcoidosis.
Must have non-caseating granulomas in at least one organ. (Non-caseating granulomas are a type of inflammation found in certain diseases.)
Other causes of granulomas must be ruled out.
Must have been treated with infliximab for at least 6 months. (Infliximab is a medication used to treat certain immune system disorders.)
Must have been taking a steroid dosage of 10 mg/day or less for at least 6 months. (Steroids are medications used to reduce inflammation.)
Must have no disease activity for at least 6 months, indicated by an ePOST score of 0. (ePOST is a scoring system used to measure disease activity.)
Must have normal levels of ACE and serum calcium. (ACE is an enzyme, and serum calcium is a measure of calcium in the blood.)
Must have signed an informed consent form. (Informed consent is a process of understanding the details and risks of the study before agreeing to participate.)

Who cannot join the trial?

1 criterion

Patients with **immune system disorders** cannot participate. The immune system is the body's defense against infections and illnesses.

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Verified sites

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

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Assistance Publique Hopitaux De Marseille
Marseille, France
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Centre Hospitalier Lyon Sud
Pierre Benite, France
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Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France

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 TNF-alpha antagonist. TNF-alpha is a substance in the body that can cause inflammation and lead to various diseases, including sarcoidosis. Infliximab works by blocking the action of TNF-alpha, which helps reduce inflammation and can lead to remission in patients with sarcoidosis. In this trial, the role of infliximab is to help maintain remission in patients who have already achieved it after using this medication.

What is already known about the treatment

Infliximab – Infliximab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently used in medicine to help manage immune system disorders, and its effectiveness is well-documented in medical literature. The main therapeutic indication for infliximab in this trial is to maintain remission in patients with sarcoidosis, a condition characterized by inflammation. At the molecular level, infliximab works by blocking a protein called TNF-alpha, which plays a role in causing inflammation in the body. It is classified pharmacologically as a TNF-alpha antagonist, which means it helps reduce inflammation by inhibiting this specific protein.

Investigated diseases

Immune System Disorders – These disorders occur when the immune system does not function properly, either by overreacting or underreacting to stimuli. In autoimmune diseases, the immune system mistakenly attacks the body's own cells, leading to inflammation and tissue damage. In immunodeficiency disorders, the immune system's ability to fight infections is compromised, making individuals more susceptible to infections. Allergic reactions are another type of immune system disorder, where the immune system overreacts to harmless substances. The progression of these disorders varies widely, with some remaining stable over time and others worsening, leading to chronic symptoms. The specific symptoms and progression depend on the type of immune system disorder present.