Recruiting

Study on the Effects of Rituximab and Obinutuzumab in Patients with Systemic Lupus Erythematosus (SLE)

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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 effects of two medications, Rituximab and Obinutuzumab, on patients with Systemic Lupus Erythematosus (SLE). SLE is a chronic autoimmune disease where the immune system mistakenly attacks healthy tissues, causing inflammation and damage to various parts of the body, including the skin, joints, and kidneys. The purpose of this study is to explore how these medications affect certain immune cells in the blood and tissues of SLE patients.

Participants in the study will receive either Rituximab or Obinutuzumab, both of which are administered through an intravenous infusion, meaning they are given directly into a vein. The study will last for up to 52 weeks, during which time researchers will monitor changes in specific immune cells, particularly a type of white blood cell called B cells, in the blood and lymph nodes. The study aims to identify changes in these cells and how they relate to the progression and treatment response of SLE.

By examining these effects, the study hopes to find new markers that can help tailor treatments to individual patients, a concept known as personalized medicine. This could lead to better management of SLE by predicting how patients will respond to these treatments. The study will also look at how these changes in immune cells correlate with improvements in the symptoms and severity of SLE, providing valuable insights into the disease and its treatment.

The research process

The trial runs in 6 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. These include a diagnosis of systemic lupus erythematodes (SLE) and a SLEDAI-2K score of 6 or higher. Participants must be between 18 and 75 years old and have a disease severity that justifies the use of anti-CD20 therapy.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current state of the disease. This includes measuring the levels of certain immune cells in the blood and lymph nodes.
Step 3
Treatment administration
Participants receive treatment with either rituximab or obinutuzumab. Both medications are administered intravenously, meaning they are given through a vein. The specific dosage and frequency are determined by the study protocol.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to observe the effects of the treatment. This includes checking the levels of CD19+ B cells in the blood and lymph nodes. The goal is to see a decrease in these cells, which is a sign of the treatment's effectiveness.
Step 5
Evaluation of treatment response
The response to treatment is evaluated by correlating the depletion of CD19+ cells with clinical improvements. Improvements are measured using specific scales that assess disease activity.
Step 6
Study completion
The study is expected to conclude by June 2027. At this point, a final assessment is conducted to determine the overall effectiveness of the treatments and to identify any potential biomarkers for personalized medicine in SLE.

Who can join the trial?

7 criteria

The study is for patients with **Systemic Lupus Erythematosus (SLE)**, a condition where the immune system attacks the body's own tissues.
Participants must meet specific criteria set by medical organizations, such as the **ACR 1997**, **SLICC**, or **ACR/EULAR 2019**. These are guidelines used to diagnose SLE.
Participants need to have a **SLEDAI-2K score** of 6 or higher. This score measures the activity of the disease, with higher numbers indicating more active disease.
Participants should be between the ages of 18 and 75.
Participants must have a level of disease severity and resistance to treatment that justifies the use of **anti-CD20 therapy**, a type of treatment not typically used for SLE.
Both male and female participants are eligible for the study.
The study does not include vulnerable populations, which means it is not designed for groups that might need special protection or care.

Who cannot join the trial?

9 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to medications used in the study are excluded.
Patients with active infections that require treatment are not eligible.
People with a history of cancer within the last five years, except for certain skin cancers, cannot join the study.
Individuals with significant heart problems, such as heart failure, are excluded.
Patients with severe liver or kidney disease are not eligible.
People who have received certain treatments, like chemotherapy, within the last six months cannot participate.
Individuals with a history of drug or alcohol abuse within the past year are excluded.
Patients who are unable to comply with the study procedures or follow-up visits are not eligible.

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Verified sites

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands

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Investigated drugs

Rituximab
is a medication used in this study to explore its effects on the immune system, particularly on lymphocyte subsets in patients with Systemic Lupus Erythematosus (SLE). It works by targeting specific cells in the immune system, which may help in reducing inflammation and disease activity in SLE.
Obinutuzumab
is another medication being studied for its impact on the immune cells of SLE patients. Similar to rituximab, it is designed to interact with certain immune cells, potentially altering their behavior and helping to manage the symptoms of SLE. The study aims to compare its effects with those of rituximab to better understand their roles in treating SLE.

What is already known about the treatment

Rituximab
Rituximab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently used in medicine to treat various autoimmune diseases and certain types of cancer, with extensive documentation in medical literature. The main therapeutic indication for rituximab in this context is systemic lupus erythematosus (SLE). It works by targeting and depleting CD20-positive B cells, which are a type of white blood cell involved in the immune response. Rituximab is classified as a monoclonal antibody.
Obinutuzumab
Obinutuzumab is also administered via intravenous infusion. It is used in the treatment of certain blood cancers and is being studied for its effects on autoimmune diseases like systemic lupus erythematosus (SLE). Obinutuzumab targets CD20-positive B cells, similar to rituximab, but it is designed to enhance the immune system's ability to destroy these cells. It is classified as a monoclonal antibody and is noted for its potential to offer a different therapeutic effect compared to other treatments in its class.

Investigated diseases

Systemic Lupus Erythematosus – This is an autoimmune disease where the body's immune system mistakenly attacks its own tissues, affecting various organs such as the skin, joints, kidneys, and brain. The disease can cause inflammation and damage in these areas, leading to symptoms like fatigue, joint pain, skin rashes, and fever. The progression of the disease can vary greatly among individuals, with periods of flares and remissions. Over time, the inflammation can lead to tissue damage and complications in the affected organs. The exact cause of systemic lupus erythematosus is not fully understood, but it is believed to involve a combination of genetic, environmental, and hormonal factors.