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Study on Methotrexate and Prednisone for Treating Lung Sarcoidosis in Patients

Verified siteRegistered drugNo placebo
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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 effectiveness of two medications, methotrexate and prednisone, as treatments for pulmonary sarcoidosis. Pulmonary sarcoidosis is a condition where small clusters of inflammatory cells, called granulomas, form in the lungs, which can affect breathing. The purpose of the study is to compare how well these two medications work as the first treatment option for this condition.

Participants in the study will be randomly assigned to receive either methotrexate or prednisone. Methotrexate is a medication that works by interfering with the growth of certain cells, while prednisone is a type of corticosteroid that helps reduce inflammation in the body. Both medications will be taken in tablet form by mouth. The study will last for a period of 24 weeks, during which the effects of the medications on lung function and overall health will be monitored.

Throughout the study, participants will have regular check-ups to assess their lung function and monitor any changes. The main focus will be on measuring the change in lung capacity, specifically the forced vital capacity, which is a measure of how much air a person can exhale after taking a deep breath. Additionally, other health markers, known as biomarkers, will be evaluated to provide further insights into the effectiveness and tolerability of the treatments.

The research process

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

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient is confirmed to have a diagnosis of pulmonary sarcoidosis based on specific criteria.

    The patient must be at least 18 years old and have a pulmonary indication for treatment with specific lung function test results.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the patient's lung function, including a test called Forced Vital Capacity (FVC) and a diffusion capacity test for carbon monoxide.

    These tests help determine the baseline lung function before starting the treatment.

  3. Step 3

    Treatment phase

    The patient is randomly assigned to receive either methotrexate or prednisone as the first-line therapy.

    Both medications are administered orally. The specific dosage and frequency are determined by the trial protocol.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, the patient's lung function is regularly monitored to assess any changes in the Forced Vital Capacity.

    Additional tests may include the measurement of biomarkers to evaluate the treatment's effectiveness and tolerability.

  5. Step 5

    Completion of trial

    The trial is expected to conclude by March 1, 2025.

    Upon completion, the final results will be analyzed to determine the effectiveness of methotrexate compared to prednisone in treating pulmonary sarcoidosis.

Who can join the trial?

4 criteria

  • The patient must have a diagnosis of **sarcoidosis**. This is a condition that affects the lungs and can be confirmed by specific medical criteria or by a team of experts based on clinical and imaging findings.
  • The patient must be **18 years or older**.
  • The patient must have a lung-related reason for treatment, with lung tissue involvement shown on an X-ray or CT scan done within the last three months, as determined by the doctor following current guidelines.
  • The patient must have specific lung function test results: a **forced vital capacity (FVC)**, which measures how much air you can exhale, of 90% or less of what is expected; or a **diffusion capacity of the lung for carbon monoxide (DLCO)**, which measures how well your lungs transfer gas, of 70% or less of what is expected; or a decline of 5% or more in FVC or 10% or more in DLCO in the past year. These tests use standard reference values.
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Investigated drugs

  • Methotrexate

    is being studied as a first-line treatment for pulmonary sarcoidosis. It is a medication that can help reduce inflammation and suppress the immune system, which may be beneficial in managing the symptoms of sarcoidosis.

  • Prednisone

    is also being evaluated as a first-line treatment for pulmonary sarcoidosis. It is a type of corticosteroid that works by reducing inflammation in the body, which can help alleviate symptoms associated with sarcoidosis.

What is already known about the treatment

  • Methotrexate

    Methotrexate is typically administered orally or by injection and is being studied as a first-line treatment for pulmonary sarcoidosis. It is currently under investigation in clinical trials to assess its effectiveness and tolerability compared to prednisone. Methotrexate is primarily used to treat certain types of cancer and autoimmune diseases. It works by inhibiting the enzyme dihydrofolate reductase, which is crucial for DNA synthesis and cell replication, thereby reducing inflammation. It is classified as an antimetabolite and immunosuppressant.

  • Prednisone

    Prednisone is usually taken orally and is a well-established treatment for pulmonary sarcoidosis. It is being compared to methotrexate in clinical trials to evaluate its effectiveness as a first-line therapy. Prednisone is commonly used to treat inflammatory and autoimmune conditions. It works by mimicking the effects of cortisol, a natural hormone, to reduce inflammation and suppress the immune system. It is classified as a corticosteroid.

Investigated diseases

Pulmonary sarcoidosis – Pulmonary sarcoidosis is a condition characterized by the growth of tiny clusters of inflammatory cells, called granulomas, in the lungs. These granulomas can cause the lung tissue to become inflamed and may lead to scarring over time. The disease often begins with symptoms such as a persistent cough, shortness of breath, and chest pain. As it progresses, it can affect lung function, leading to decreased ability to breathe deeply or efficiently. The exact cause of pulmonary sarcoidosis is unknown, but it is believed to involve an abnormal immune response. The progression of the disease can vary greatly among individuals, with some experiencing mild symptoms and others facing more significant respiratory challenges.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514055-15-00Protocol codeNL71782.078.19Estimated enrolment132 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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