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Study on Rituximab for Patients with Rheumatoid Arthritis: Comparing 200 mg and 1g Doses for Maintenance Treatment

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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 in patients with Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The study aims to compare a lower dose of 200 mg of Rituximab given every six months to the standard higher dose of 1 gram, to see if the lower dose is just as effective in managing the disease.

Participants in the study will receive Rituximab through an infusion, which means the medication is delivered directly into the bloodstream. The study will last for about a year, during which the participants' disease activity will be monitored at the start, at six months, and at the end of the study. This will help determine if the lower dose of Rituximab can maintain the same level of disease control as the higher dose.

The goal of the study is to find out if using a smaller amount of Rituximab can still effectively manage Rheumatoid Arthritis without increasing the disease activity. This could potentially lead to fewer side effects and a more convenient treatment option for patients. The study will also track any changes in the participants' health and any side effects they may experience during the trial period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will have an initial visit. During this visit, your eligibility will be confirmed based on specific criteria such as age, diagnosis of rheumatoid arthritis, and previous treatment with rituximab.

    You will be asked to provide written informed consent to participate in the study. This means you agree to follow the study procedures and understand the potential risks and benefits.

  2. Step 2

    First infusion

    You will receive an infusion of rituximab. The dose will be 200 mg, administered through an infusion, which is a method of delivering medication directly into your bloodstream.

    This infusion will occur every 6 months as part of the maintenance treatment for rheumatoid arthritis.

  3. Step 3

    Follow-up assessments

    You will have follow-up assessments at 6 months and 12 months. These assessments will include measuring your disease activity using a score called DAS28-CRP, which evaluates the severity of your rheumatoid arthritis.

    Additional evaluations will include checking your joint counts, levels of inflammation, and overall health status. You may also be asked to complete questionnaires about your health and quality of life.

  4. Step 4

    Additional infusions

    You will receive additional infusions of rituximab every 6 months throughout the study period. The purpose is to maintain the treatment effect on your rheumatoid arthritis.

    The study aims to compare the effectiveness of the 200 mg dose to the standard 1g dose in controlling disease activity.

  5. Step 5

    Final assessment

    At the end of the 12-month period, a final assessment will be conducted. This will include a comprehensive evaluation of your rheumatoid arthritis activity and overall health.

    The results will help determine the effectiveness of the lower dose of rituximab in maintaining disease control.

Who can join the trial?

9 criteria

  • Must be at least 18 years old.
  • Must have a diagnosis of Rheumatoid Arthritis (RA) according to specific medical guidelines.
  • Must have a DAS28 score of 5.1 or less. DAS28 is a measure of disease activity in rheumatoid arthritis.
  • Must currently be receiving maintenance treatment with Rituximab, a medication used to treat RA, and have completed at least the first cycle of treatment.
  • The last Rituximab infusion must have been between 6 and 18 months before joining the study.
  • Must be taking corticosteroids at a dose of 10 mg per day or less within 4 weeks before joining the study. Corticosteroids are medications used to reduce inflammation.
  • Must be affiliated with a social insurance system or be a beneficiary.
  • Must provide written informed consent to participate in the study, which means agreeing to join the study after understanding all the details.
  • Must use an effective method of birth control during the study.

Who cannot join the trial?

3 criteria

  • Patients who do not have Rheumatoid Arthritis cannot participate. Rheumatoid Arthritis is a condition where the body's immune system attacks its own joints, causing pain and swelling.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups who may have difficulty giving informed consent or are at higher risk of harm.
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Investigated drugs

Rituximab is a medication used in this clinical trial to treat patients with rheumatoid arthritis. It works by targeting specific cells in the immune system that are involved in the inflammation and joint damage associated with rheumatoid arthritis. By reducing the activity of these cells, rituximab helps to decrease inflammation and slow down the progression of the disease, potentially improving symptoms and quality of life for patients. In this trial, the effectiveness of a lower dose of rituximab is being compared to the standard dose to see if it can provide similar benefits with fewer side effects.

What is already known about the treatment

Rituximab – Rituximab is administered as an intravenous infusion, meaning it is given directly into a vein through a drip. It is currently used in medicine to treat rheumatoid arthritis, a condition that causes pain and swelling in the joints. The main therapeutic indication for rituximab in this context is to help manage and reduce the symptoms of rheumatoid arthritis. At the molecular level, rituximab works by targeting and attaching to a specific protein called CD20 found on the surface of certain immune cells, leading to their destruction and reducing inflammation. It is classified as a monoclonal antibody, a type of medication designed to target specific cells in the body.

Investigated diseases

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically begins with inflammation in the synovial membrane, leading to swelling and pain. Over time, this inflammation can cause damage to the cartilage and bone within the joint. The disease often progresses symmetrically, meaning it affects the same joints on both sides of the body. As it advances, rheumatoid arthritis can lead to joint deformity and loss of function. In addition to joint issues, it may also cause systemic symptoms such as fatigue and fever.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519991-18-00Protocol code9424Estimated enrolment260 patientsSponsorLes Hopitaux Universitaires De Strasbourg

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