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Study on Abatacept for Patients with IgG4-Related 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 IgG4-related disease, which is a rare inflammatory condition that can affect various organs in the body. The study will use a treatment called abatacept, which is a medication designed to help reduce inflammation by targeting specific cells in the immune system. The purpose of the study is to see if abatacept can effectively reduce the risk of the disease coming back after treatment.

Participants in the study will receive either abatacept or a placebo. The study will last for a total of 48 weeks, during which time the effects of the treatment will be monitored. Abatacept is administered through a method called subcutaneous use, which means it is given as an injection under the skin. The goal is to determine if abatacept can help prevent the recurrence of symptoms in patients with IgG4-related disease.

Throughout the study, participants will be regularly assessed to track their progress and any changes in their condition. The trial aims to provide valuable information on whether abatacept can be a beneficial treatment option for those suffering from IgG4-related disease, potentially offering a new way to manage this condition and improve patient outcomes.

The research process

The trial runs in 4 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, eligibility is confirmed based on specific criteria. Participants must be of legal age, able to provide informed consent, and have active IgG4-related disease. This condition should either be untreated or have relapsed with a specific disease activity index.
The study focuses on the treatment of IgG4-related disease using the medication abatacept.
Step 2
Treatment initiation
The treatment involves the administration of abatacept through subcutaneous injections. The dosage and frequency of administration are determined by the study protocol and are designed to assess the medication's effectiveness in reducing disease recurrence.
Participants will receive these injections over a period of 48 weeks.
Step 3
Monitoring and assessment
Throughout the trial, participants will undergo regular monitoring to assess the effectiveness of the treatment. This includes evaluating the reduction in disease recurrence compared to a placebo group.
The primary goal is to demonstrate the efficacy of abatacept in managing IgG4-related disease.
Step 4
Completion of the trial
The trial is expected to conclude by August 2026. At the end of the study period, participants will undergo a final assessment to determine the overall impact of the treatment.
The results will contribute to understanding the potential benefits of abatacept for patients with IgG4-related disease.

Who can join the trial?

3 criteria

Male or female participants who are of legal age and can give their agreement to join the study.
Participants must have an active condition called IgG4-related disease. This means the disease is currently affecting them. They should either not have received treatment before or have a disease that has come back with a score greater than 2 on a specific scale used to measure the disease's activity.
Participants must meet the 2019 ACR/EULAR Classification Criteria for IgG4-related disease. This is a set of guidelines used by doctors to confirm the diagnosis of this disease.

Who cannot join the trial?

10 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who have received certain medications that could affect the study results.
Patients who have a history of cancer, except for certain types of skin cancer.
Patients who have a condition called **IgG4-related disease** that is not stable or controlled.
Patients who have had a recent surgery or are planning to have surgery during the study.

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Ospedale San Raffaele S.r.l.
Milan, Italy

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Investigated drugs

Abatacept is a medication used in this clinical trial to help reduce the risk of disease recurrence in patients with IgG4-Related Disease. It works by interfering with the activity of certain immune cells, specifically B and T cells, which are involved in the inflammation process. By targeting these cells, abatacept aims to decrease the immune response that contributes to the disease, potentially leading to fewer symptoms and a lower chance of the disease coming back.

Abatacept

What is already known about the treatment

Abatacept – This medication is administered via injection, typically under the skin or directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating IgG4-related disease, a condition characterized by inflammation and tissue damage. Abatacept works by interfering with the activation of T cells, a type of immune cell, thereby reducing inflammation. It belongs to a class of drugs known as selective co-stimulation modulators, which help regulate the immune system's response.

Investigated diseases

IgG4-related disease – This is a chronic inflammatory condition characterized by the infiltration of IgG4-positive plasma cells into various organs, leading to tissue swelling and fibrosis. It can affect multiple organs, including the pancreas, salivary glands, and lymph nodes, often causing them to enlarge. The disease progresses with periods of activity and remission, where symptoms may worsen and then improve. Over time, the affected tissues may become hardened due to fibrosis, potentially impairing their function. The exact cause of IgG4-related disease is not well understood, but it is thought to involve an abnormal immune response. Symptoms can vary widely depending on the organs involved, ranging from mild discomfort to more significant organ dysfunction.