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Study on the Effects and Safety of Rituximab and Sodium Chloride in Patients with Active Systemic Sclerosis

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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 Rituximab on patients with a condition known as Systemic Sclerosis. Systemic Sclerosis, also known as scleroderma, is a disease that causes the skin and other organs to harden and tighten. The study will also use a solution called Sodium Chloride as part of the treatment process. The purpose of this study is to evaluate how effective repeated infusions of Rituximab are in preventing organ involvement and stopping the progression of the disease.

Participants in the study will receive either Rituximab or a placebo, which is a substance with no active medication, over a period of one year. The study will monitor the participants to see if there are any differences in the progression of the disease between those receiving Rituximab and those receiving the placebo. The main focus will be on changes in skin and lung involvement, which are common issues in Systemic Sclerosis.

Throughout the study, additional outcomes will be assessed, such as changes in other organs, quality of life, and patient satisfaction. The study will also look at the safety of the treatment and its cost-effectiveness. The trial is expected to continue for a total of 18 months, with follow-up assessments to gather comprehensive data on the effects of the 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, you will be informed about the purpose and procedures involved. The study aims to evaluate the efficacy and safety of repeated rituximab infusions in patients with active systemic sclerosis, a condition affecting the skin and internal organs.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes checking if you have early or progressive systemic sclerosis and are on stable background therapy.
Step 3
Treatment administration
If eligible, you will receive rituximab infusions. The medication is administered intravenously, meaning it is given through a vein. The dosage is 500 mg of rituximab mixed in a solution for infusion. You will also receive a sodium chloride solution to help with the infusion process.
Step 4
Follow-up visits
Regular follow-up visits will be scheduled to monitor your health and the effects of the treatment. These visits will occur over a period of 12 months. During these visits, your skin and lung involvement will be assessed to check for any progression of the disease.
Step 5
Evaluation of outcomes
After 12 months, the primary outcome will be evaluated. This involves checking for any differences in disease progression between those receiving rituximab and those receiving a placebo. Disease progression is measured by changes in skin and lung function.
Step 6
Secondary assessments
Secondary outcomes will be assessed after 12 and 18 months. These include changes in other organ involvement, quality of life, and patient satisfaction. Safety and cost-effectiveness will also be evaluated.

Who can join the trial?

5 criteria

Patients must have systemic sclerosis (SSc), which is a condition that affects the skin and other organs.
The disease should be in the early stage (less than 4 years since diagnosis) or be progressive, meaning it is getting worse over time.
Patients should be on a stable background therapy, which means their current treatment plan should not have changed recently.
Both men and women can participate in the study.
Participants should be within the age range of 18 to 64 years old.

Who cannot join the trial?

10 criteria

Patients with any other serious health condition that might interfere with the study.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who are currently pregnant or breastfeeding.
Patients who have a history of severe allergic reactions to medications.
Patients who are currently participating in another clinical trial.
Patients who have received certain medications that might interfere with the study within the last 3 months.
Patients with a history of cancer within the last 5 years, except for certain types of skin cancer.
Patients with a history of drug or alcohol abuse within the last year.
Patients who have had a major surgery within the last 3 months.
Patients with uncontrolled high blood pressure.

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Verified sites

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

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

Trial locations

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Investigated drugs

Rituximab is a medication used in this clinical trial to help manage symptoms of a condition called systemic sclerosis, which affects the skin and other organs. This medication works by targeting specific cells in the immune system that may be causing inflammation and damage. By reducing the activity of these cells, Rituximab aims to prevent further organ involvement and slow down the progression of the disease. Patients in the trial receive repeated infusions of Rituximab to assess its effectiveness and safety over a one-year period.

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. Currently, it is being studied in clinical trials for its effectiveness in treating systemic sclerosis, a condition that affects the skin and internal organs. Rituximab works by targeting and reducing specific immune cells called B-cells, which are involved in the body's immune response. This action helps to decrease inflammation and slow down the progression of the disease. It is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the body.

Investigated diseases

Systemic sclerosis – Systemic sclerosis is a chronic connective tissue disease characterized by the hardening and tightening of the skin and connective tissues. It progresses by causing an overproduction of collagen, leading to fibrosis of the skin and internal organs. As the disease advances, it can affect the skin, blood vessels, and internal organs such as the lungs, heart, and kidneys. The skin may become thickened and lose its elasticity, while blood vessels can become narrowed, leading to reduced blood flow. Lung involvement may result in interstitial lung disease, causing breathing difficulties. Over time, systemic sclerosis can lead to significant changes in organ function and structure.