Not recruiting

Study on the Effects of Belimumab and Rituximab for Patients with Severe Systemic Lupus Erythematosus

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 a disease called Systemic Lupus Erythematosus (SLE), which is a condition where the immune system mistakenly attacks healthy tissues in the body. The study is testing a combination of two treatments: Benlysta (belimumab) and Truxima (rituximab). These medications are designed to help manage the symptoms of SLE by targeting specific parts of the immune system. Benlysta is given as an injection under the skin, while Truxima is administered through an infusion into a vein.

The purpose of the study is to see if the combination of Benlysta and Truxima is more effective than the usual treatments, which include medications like mycophenolate and steroids. Participants in the study will receive either the combination treatment or the standard treatment. The study will last for about two years, during which time the effectiveness of the treatments will be monitored. This includes looking at how well the treatments reduce the activity of the disease and how they affect the immune system over time.

Throughout the study, researchers will also keep track of any side effects or safety concerns related to the treatments. The goal is to find out if the combination of Benlysta and Truxima can provide a better long-term outcome for people with severe SLE compared to the standard treatments. This research could lead to improved treatment options for those living with this challenging 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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of severe systemic lupus erythematosus (SLE) and ensuring the presence of specific autoantibodies.
A series of tests are performed to establish baseline health status and disease activity.
Step 2
Treatment initiation
The treatment phase begins with the administration of belimumab and rituximab. Belimumab is given as a subcutaneous injection using a pre-filled pen containing 200 mg of the medication.
Rituximab is administered intravenously as a 100 mg concentrate for infusion. The frequency and duration of these treatments are determined by the study protocol.
Step 3
Monitoring and follow-up
Regular monitoring is conducted to assess the effectiveness of the treatment and to track any side effects. This includes blood tests and other evaluations to measure disease activity and response to the medication.
The primary goal is to achieve long-term reduction in disease activity and to monitor for any treatment failures over a two-year period.
Step 4
Evaluation of outcomes
At 28 weeks, specific outcomes such as the reduction of disease-related autoantibodies and renal response are evaluated.
Throughout the 104-week study period, sustained B-cell depletion and reduction of autoantibodies are assessed, along with safety and toxicity monitoring.
Step 5
Completion of study
Upon completion of the study, a final assessment is conducted to evaluate the overall effectiveness of the treatment and any long-term effects.
Participants are provided with information regarding their health status and any necessary follow-up care.

Who can join the trial?

6 criteria

Participants must be adults aged 18 years or older.
Participants need to have a clinical diagnosis of **Systemic Lupus Erythematosus (SLE)**, which is a condition where the immune system attacks the body's own tissues, according to specific criteria from 2012.
Participants should have severe, active SLE disease. This means they have a high level of disease activity, such as a score of 12 or more on a specific index called **SLEDAI** (SLE Disease Activity Index), or worsening symptoms affecting major organs like the brain, blood vessels, kidneys, heart, muscles, or blood cells.
Participants must have ongoing or worsening disease activity despite using standard treatments like mycophenolate or azathioprine, which are medications that suppress the immune system.
Participants need to test positive for specific antibodies related to SLE. This includes having a positive **ANA** (antinuclear antibody) test or a positive **anti-DNA** test, which are blood tests that help diagnose SLE.
Female participants must not be pregnant or nursing. They should either be unable to have children due to medical reasons or agree to use effective birth control methods to prevent pregnancy during the study and for a period after the study ends.

Who cannot join the trial?

10 criteria

Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to the study medications are excluded.
Patients with active infections that require treatment are not eligible.
Patients with other autoimmune diseases that might interfere with the study are excluded.
Patients who have received certain treatments for lupus within a specific time frame before the study cannot participate.
Patients with significant heart, liver, or kidney problems are not eligible.
Patients who have participated in another clinical trial recently are excluded.
Patients with a history of cancer, except for certain types of skin cancer, are not eligible.
Patients with a history of drug or alcohol abuse are excluded.
Patients who are unable to comply with the study procedures are not eligible.

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Verified sites

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

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands
Stichting Radboud University Medical Center
Responsive
Nijmegen, The Netherlands

Trial locations

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Investigated drugs

Belimumab
is a medication used in this trial to help manage lupus by targeting and reducing the activity of certain immune cells called B-cells. It is used in combination with other treatments to see if it can improve long-term outcomes for patients with lupus.
Rituximab
is another medication in the trial that works by depleting B-cells, which are part of the immune system. It is used alongside belimumab to determine if this combination can more effectively control lupus symptoms compared to other treatments.
Mycophenolate
is a standard treatment for lupus that helps suppress the immune system to prevent it from attacking the body. It is used in the trial as a comparison to see how well the new combination of belimumab and rituximab works.
Steroids
are commonly used in lupus treatment to quickly reduce inflammation and suppress the immune system. In this trial, they are part of the standard care against which the new combination therapy is being compared.

What is already known about the treatment

Belimumab
Belimumab is administered via intravenous infusion or subcutaneous injection. It is currently used in the treatment of systemic lupus erythematosus (SLE) and is well-documented in medical literature. The main therapeutic indication 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 white blood cell that can contribute to the autoimmune response in lupus. It is classified as a monoclonal antibody.
Rituximab
Rituximab is administered through intravenous infusion. It is used in the treatment of various autoimmune diseases and certain types of cancer, with extensive documentation in medical literature. The primary therapeutic indication in this context is for systemic lupus erythematosus (SLE). Rituximab works by targeting the CD20 protein on the surface of B cells, leading to their destruction, which helps in reducing the autoimmune activity. It is classified as a monoclonal antibody.

Investigated diseases

Systemic Lupus Erythematosus – This is an autoimmune disease where the body's immune system mistakenly attacks healthy tissues. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. Symptoms often include fatigue, joint pain, skin rashes, and fever. The disease can progress with periods of flares, where symptoms worsen, and remissions, where symptoms improve. Over time, it may lead to inflammation and damage in the affected organs. The severity and progression of symptoms can vary widely among individuals.