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A study to compare two different dosing methods of tocilizumab in patients with rheumatoid arthritis who have low disease activity or are in clinical remission

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 study focuses on rheumatoid arthritis, a disease that causes inflammation, pain, and swelling in the joints. The research aims to compare two different ways of giving the medication tocilizumab to people whose disease is currently in a state of low activity or clinical remission, which means the symptoms are very mild or not present at all. In this study, the medication is administered through an intravenous infusion, which is a method of delivering medicine directly into a vein using a tube.

The purpose of the study is to evaluate whether a specific dosing method, known as dose-banding, is as effective as dosing based on a person's body weight. During the study, participants will receive tocilizumab through regular infusions. The activity of the disease will be monitored using a tool called the DAS28, which is a score used by healthcare professionals to measure how much inflammation and joint damage is present. This process will be followed over a period of several months to observe any changes in the condition.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>administration of medication</b>

    An intravenous infusion, which is a method of delivering medication directly into a vein, of 840 mg of tocilizumab is administered.

    This medication is provided as a solution for infusion.

  2. Step 2

    <b>monitoring and assessment</b>

    The DAS28 activity score, a measurement used to track the status of rheumatoid arthritis (a condition causing joint inflammation), is evaluated to monitor changes in disease activity.

    The change in this score is measured from the start of the study (month 0) to three months (month 3) into the process.

Who can join the trial?

8 criteria

  • You must be older than 18 years of age.
  • You must have been diagnosed with rheumatoid arthritis, which is a type of long-term swelling and pain in the joints, based on specific medical standards.
  • Your disease must currently show low disease activity or remission, meaning your symptoms are currently very mild or mostly gone, as measured by a score called DAS28 (a tool doctors use to track how active the disease is).
  • You must be able to receive tocilizumab, a specific medication, through an infusion (a process where medicine is delivered directly into a vein).
  • You must have previously tried and not found success with cDMARDs or bDMARDs, which are different types of medicines used to manage joint swelling and prevent damage.
  • You must be taking a stable dose of certain allowed medications for at least 3 months, such as cDMARDs (traditional medicines for arthritis), NSAIDs (medicines used to reduce pain and swelling), analgesics (painkillers), or corticosteroids (steroid medicines used to reduce inflammation) at a low dose.
  • You must sign an informed consent form, which is a document where you agree to participate after understanding all the study details.
  • You must have coverage through a social security scheme, which is a government or insurance system that helps pay for medical care.

Who cannot join the trial?

9 criteria

  • Having an active neoplasm, which is a currently growing or spreading cancer.
  • Using the medicine Tocilizumab to treat a condition other than rheumatoid arthritis, which is a type of long-term swelling and pain in the joints.
  • Using Tocilizumab at a dose that is not 8 mg/kg, which means the amount of medicine given based on a person's body weight.
  • Having diverticulitis, which is inflammation or infection in small pouches that can form in the wall of the digestive system, or having a history of digestive perforation, which is a hole that develops through the wall of the stomach or intestines.
  • Being pregnant at the time of the study. Women who are able to have children will undergo a blood pregnancy test to confirm this.
  • Having an active hepatitis B, which is a serious liver infection caused by a virus.
  • Having untreated latent tuberculosis, which is a form of tuberculosis where the bacteria are present in the body but are "sleeping" and not currently causing symptoms or spreading.
  • Having a severe or active infection, which is a serious illness caused by germs, though having COVID-19 is not an exclusion.
  • Being part of a vulnerable group, which includes minors (people under the legal age of adulthood), or adults who are under guardianship or curatorship (individuals who have a legal person appointed to make decisions for them).
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Investigated drugs

Tocilizumab is a medication given through a vein that helps to reduce inflammation in people living with rheumatoid arthritis by targeting specific parts of the immune system.

What is already known about the treatment

Tocilizumab - This medication is an approved treatment used to manage rheumatoid arthritis and is administered as a liquid through a vein during an infusion. It belongs to a group of drugs called interleukin-6 inhibitors that work by blocking a specific protein in the body that causes swelling and joint damage. By stopping this protein from sending signals to the immune system, it helps reduce inflammation and relieve pain in patients with this condition.

Investigated diseases

Rheumatoid arthritis - This is a chronic condition where the immune system mistakenly attacks the body's own tissues. It primarily affects the joints, causing inflammation in the lining that surrounds them. Over time, this inflammation can lead to swelling, pain, and stiffness. As the condition progresses, it may cause damage to the cartilage and bone within the joints. The discomfort and changes often affect multiple joints simultaneously, particularly in the hands and feet.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522319-41-00Protocol code24-AOI-MED-01Estimated enrolment122 patientsSponsorCentre Hospitalier Universitaire De Nice

sourced from the EU Clinical Trials Register and site verification

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