Recruiting

Study on Reducing Rituximab Dosage for Patients with Rheumatoid Arthritis

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 the treatment of Rheumatoid Arthritis, a chronic inflammatory disorder that primarily affects the joints. The study involves the use of a medication called Rituximab, which is administered as a solution for infusion, meaning it is given directly into the bloodstream through a vein. The trial will compare two different strategies for adjusting the dosage of Rituximab in patients who have previously responded to this treatment. The goal is to find the best way to reduce the impact of the disease while maintaining effective control over its symptoms.

Participants in the study will receive Rituximab over a period of 104 weeks, which is approximately two years. During this time, the study will explore two approaches: one that involves extending the time between doses and another that adjusts the dose based on the patient's disease activity. The trial aims to determine which method is more effective in managing Rheumatoid Arthritis and reducing the overall amount of medication needed.

The study will also monitor various aspects of the disease and treatment, such as the overall impact on the patient's health, the activity level of the disease, and any side effects that may occur. By comparing these factors, the trial seeks to provide valuable insights into optimizing Rituximab treatment for individuals with Rheumatoid Arthritis.

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 required to provide written informed consent. This confirms understanding and willingness to participate in the trial.
The patient must be at least 18 years old and have a diagnosis of rheumatoid arthritis according to specific criteria. Previous successful treatment with rituximab is necessary.
Step 2
Baseline assessment
A baseline assessment will be conducted to evaluate the current state of the patient's rheumatoid arthritis. This includes measuring disease activity and ensuring a stable dose of methotrexate or other similar medications for at least four weeks prior.
Step 3
Treatment phase
The patient will receive rituximab as a solution for infusion. The specific product and dosage will be determined based on the study arm assigned.
The treatment involves intravenous administration of rituximab. The frequency and dosage may vary, with some patients receiving a reduced dose based on disease activity.
Step 4
Monitoring and follow-up
Throughout the trial, the patient's disease impact and activity will be monitored using questionnaires and clinical assessments over a period of 104 weeks.
The cumulative dose of rituximab and any other medications will be recorded. The patient's response to treatment and any adverse events will be closely observed.
Step 5
Completion of trial
At the end of the trial period, the patient's overall response to the treatment strategy will be evaluated. This includes assessing the maintenance of disease control and any changes in medication dosage or frequency.

Who can join the trial?

8 criteria

Must be able and willing to give written permission to join the study and take part in it before any study activities begin.
Must be 18 years old or older.
Must understand and be able to write in Dutch or French.
Must have a diagnosis of rheumatoid arthritis based on specific criteria set in 2010 by the ACR/EULAR, which are organizations that classify this condition.
Must have previously responded well to rituximab, which means having at least one successful treatment cycle with it. A successful cycle is defined as a moderate or good response 16 weeks after the first dose.
Must currently be receiving treatment with rituximab.
Must need another cycle of rituximab treatment according to Belgian rules for its use in rheumatoid arthritis. This is determined by a DAS28 score of 3.2 or higher, which is a way to measure the activity of the disease.
Must have been on a stable dose of methotrexate or other similar medications known as conventional synthetic disease-modifying antirheumatic drugs (DMARDs) for at least 4 weeks before starting the study.

Who cannot join the trial?

4 criteria

Patients who do not have rheumatoid arthritis cannot participate. Rheumatoid arthritis is a condition where the body's defense system attacks its own joints, causing pain and swelling.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria ensure the safety and effectiveness of the study.

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Verified sites

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

Algemeen Stedelijk Ziekenhuis Campus Aalst
Verified
Aalst, Belgium
Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

Trial locations

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Investigated drugs

Rituximab is a medication used in this trial to treat patients with rheumatoid arthritis. It works by targeting specific cells in the immune system that contribute to inflammation and joint damage. The trial aims to find the best way to reduce the dosage or frequency of rituximab while still effectively managing the symptoms of rheumatoid arthritis.

Rituximab

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 well-established in medical literature and is used in the treatment of rheumatoid arthritis, among other conditions. The medication works by targeting and depleting specific immune cells known as B cells, which play a role in the inflammation and joint damage seen in rheumatoid arthritis. Rituximab is classified as a monoclonal antibody, a type of medication designed to bind to specific proteins in the body to alter immune responses.

Investigated diseases

Rheumatoid arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body's own tissues, leading to inflammation. Over time, this inflammation can cause damage to the joint tissues, resulting in pain, swelling, and stiffness. The disease often starts in smaller joints, such as those in the fingers and toes, and can progress to larger joints like the knees, hips, and shoulders. As the condition advances, it may lead to joint deformity and loss of function. Additionally, rheumatoid arthritis can affect other parts of the body, including the skin, eyes, lungs, and blood vessels.