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Study on the Effects of Belimumab for 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 a medication called belimumab on patients with Systemic Lupus Erythematosus (SLE), a disease where the immune system attacks the body's own tissues, causing inflammation and damage. The purpose of the study is to explore how belimumab affects certain immune cells and tissues in the body, particularly in the lymph nodes and joints.

Participants in the study will receive belimumab, which is administered as a solution for injection using a pre-filled pen. Some participants will receive other treatments for comparison. The study will observe changes in specific immune cells in the blood and lymph nodes over time, aiming to understand how these changes relate to the disease and the response to belimumab treatment. This information could help identify new ways to personalize treatment for SLE patients in the future.

The study will take place over a period of time, with regular monitoring of participants to assess the effects of the treatment. The goal is to gather valuable information that could lead to better treatment strategies for SLE, potentially improving outcomes for those affected by this condition.

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, the patient will be assessed to ensure they meet the criteria for participation. This includes having a confirmed diagnosis of systemic lupus erythematodes (SLE) and meeting specific clinical criteria such as a SLEDAI-2K score of 6 or higher.
Step 2
Medication administration
The patient will begin treatment with belimumab, administered as a subcutaneous injection. The specific product used is Benlysta 200 mg solution for injection in a pre-filled pen.
The frequency and duration of the belimumab administration will be determined by the study protocol and the patient's response to treatment.
Step 3
Monitoring and assessments
Throughout the study, the patient will undergo regular monitoring to assess the effects of belimumab on the composition of lymph nodes and inflamed synovial tissue.
Blood tests will be conducted to evaluate changes in B lineage cells, which are a type of immune cell, in the peripheral blood and lymph nodes.
Step 4
Comparison and analysis
The study will compare the effects of belimumab with other treatments, such as steroids or DMARDs, to identify specific effects of belimumab.
The primary endpoint is the change in the composition of B lineage cells, while secondary endpoints include the correlation between these changes and clinical response.
Step 5
Study completion
The study is expected to conclude by June 2027. At the end of the study, the data collected will be analyzed to determine the effectiveness of belimumab in treating SLE.

Who can join the trial?

9 criteria

Patients must have **Systemic Lupus Erythematosus (SLE)**, a condition where the immune system attacks the body's own tissues.
Patients need to meet specific criteria set by medical organizations like **ACR 1997**, **SLICC**, or **ACR/EULAR 2019**. These are guidelines used to diagnose SLE.
Patients should have a **SLEDAI-2K score** of 6 or higher. This score measures the activity of the disease.
Patients may have **active joint disease (arthritis)** in the wrist, knee, or ankle joints. This is optional.
Patients must be between the ages of 18 and 75.
Patients should be starting treatment with **belimumab**, a medication used to treat SLE.
For comparison, some patients who do not start belimumab but receive other treatments like steroids or **DMARDs** (disease-modifying antirheumatic drugs) will also be included.
Patients can use stable doses of other medications like **hydroxychloroquine**, **azathioprine**, and low-dose steroids (less than 10 mg), as well as other non-immunosuppressant medications.
All patients will be advised to use appropriate **contraceptive measures** as is standard when using these types of medications.

Who cannot join the trial?

10 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to the study medication 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 severe heart, liver, or kidney problems are excluded.
Patients who have received certain treatments for lupus within the last month are not eligible.
People with a history of drug or alcohol abuse in the past year cannot participate.
Individuals who are unable to comply with the study procedures are excluded.
Patients with other autoimmune diseases that might interfere with the study are not eligible.
People who have participated in another clinical trial within the last month cannot join this study.

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Verified sites

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

Belimumab is a medication used in this clinical trial to study its effects on patients with Systemic Lupus Erythematosus (SLE). It is designed to reduce inflammation by targeting specific immune cells that are overactive in SLE. The trial aims to observe how belimumab affects the composition of lymph nodes and inflamed synovial tissue, as well as various immune cells in the blood. The goal is to understand how belimumab can alter the immune system in SLE patients and to find new biomarkers for personalized treatment approaches.

Belimumab

What is already known about the treatment

Belimumab – Belimumab is administered as an intravenous infusion or subcutaneous injection. It is currently approved for use in treating systemic lupus erythematosus (SLE) and is well-documented in medical literature. The main therapeutic indication for belimumab is to reduce disease activity in patients with SLE. At the molecular level, belimumab works by inhibiting a protein called B-lymphocyte stimulator (BLyS), which is involved in the survival of B cells, a type of immune cell that can contribute to the symptoms of lupus. It is classified as a monoclonal antibody, specifically targeting the immune system to help manage autoimmune conditions.

Investigated diseases

Systemic Lupus Erythematosus – This is an autoimmune disease where the body's immune system mistakenly attacks healthy tissue in various parts of the body. It can affect the skin, joints, kidneys, brain, and other organs. The disease often presents with symptoms such as fatigue, joint pain, rash, and fever. Over time, it can lead to inflammation and damage in the affected organs. The progression of the disease can vary greatly among individuals, with periods of illness (flares) alternating with periods of remission. The exact cause of systemic lupus erythematosus is unknown, but it is believed to involve a combination of genetic, environmental, and hormonal factors.