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Study on the Effectiveness and Safety of Tocilizumab and Adalimumab for Patients with Severe Uveitis in Behçet’s Disease

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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 a condition called severe uveitis in people with Behçet's disease. Uveitis is an inflammation inside the eye that can lead to vision problems, and Behçet's disease is a rare disorder that causes blood vessel inflammation throughout the body. The study will compare two treatments: tocilizumab and adalimumab. Tocilizumab is a medication given as an injection under the skin, and it works by blocking a protein in the body that can cause inflammation. Adalimumab is also an injection that helps reduce inflammation by targeting a specific protein involved in the body's immune response.

The purpose of this study is to assess the benefits of tocilizumab compared to adalimumab in treating sight-threatening uveitis in Behçet's disease. Participants in the study will receive either tocilizumab or adalimumab and will be monitored over a period of time to see how well the treatments work in reducing eye inflammation and improving vision. The study will also look at how these treatments affect the need for other medications, like corticosteroids, which are often used to control inflammation.

Throughout the study, participants will have regular check-ups to monitor their eye health and overall well-being. The study aims to provide valuable information on the effectiveness and safety of these treatments for people with severe uveitis due to Behçet's disease. This research could help improve treatment options and outcomes for patients 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.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to receive either tocilizumab or adalimumab. These medications are used to treat severe uveitis associated with Behçet’s disease.

    The patient will receive a solution for injection. Tocilizumab is administered as a 162 mg solution in a pre-filled syringe, while adalimumab is provided as an 80 mg solution in a pre-filled pen. Both medications are given through subcutaneous injection.

  2. Step 2

    Treatment administration

    The patient will receive the assigned medication according to the study protocol. The frequency and duration of administration will be determined by the study guidelines and the patient's response to treatment.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient will undergo regular assessments to monitor the effectiveness and safety of the treatment. These assessments will include evaluations of ocular inflammation, visual acuity, and any side effects experienced.

    The primary goal is to achieve complete remission of ocular involvement with a low dose of prednisone by week 16. Secondary assessments will include measures of corticosteroid sparing, changes in disease activity, and quality of life evaluations.

  4. Step 4

    Follow-up visits

    The patient will have scheduled follow-up visits at weeks 4, 8, 12, 16, 24, 36, and 48. During these visits, the patient's response to treatment will be evaluated, and any necessary adjustments to the treatment plan will be made.

    The study will also assess the time to response onset, rate of relapse, and changes in various health indicators over the course of the trial.

  5. Step 5

    Completion of the study

    The study is expected to conclude by April 2028. Upon completion, the patient's overall response to the treatment will be analyzed, and the findings will contribute to understanding the efficacy and safety of tocilizumab and adalimumab in treating severe uveitis in Behçet’s disease.

Who can join the trial?

10 criteria

  • Must be **18 years or older**.
  • Must be part of a **social security system**. Those with universal medical coverage are eligible.
  • Must provide **written, informed consent** before any study procedures.
  • Must have a **diagnosis of Behçet's disease** or a history of mouth sores, according to specific international criteria.
  • Must have a **diagnosis of non-infectious uveitis** (eye inflammation) in at least one eye, according to specific classification criteria.
  • Must have **sight-threatening uveitis**, defined as a significant drop in vision or retinal inflammation.
  • Must have a **chest X-ray or CT scan** within 12 weeks before joining, showing no active tuberculosis, infection, or cancer.
  • For women who can become pregnant, a **negative pregnancy test** is required.
  • For those who can have children, must agree to use **birth control** during the study and for a few months after stopping the study medication.
  • Must have a **negative TB test** within 12 weeks before joining. If the test is positive, a chest X-ray must show no active TB, and there should be no symptoms of TB. If there is a latent TB infection, the person must agree to complete preventive treatment.

Who cannot join the trial?

8 criteria

  • Patients with other serious eye conditions that are not related to **Behçet's disease**.
  • Patients who have had recent eye surgery or are planning to have eye surgery during the study period.
  • Patients who are currently using other medications that might interfere with the study treatment.
  • Patients with a history of severe allergic reactions to similar medications.
  • Patients with certain infections that could worsen with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients with certain chronic diseases that are not well controlled.
  • Patients who have participated in another clinical trial recently.
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Investigated drugs

  • Adalimumab

    is a medication used to reduce inflammation by blocking a specific protein in the body. In this trial, it is being tested for its effectiveness and safety in treating severe uveitis, which is an eye condition associated with Behçet’s disease. The goal is to see how well it can help manage the symptoms and prevent further damage to the eyes.

  • Tocilizumab

    is another medication that works by inhibiting a different protein involved in the inflammatory process. It is also being evaluated in this trial for its potential benefits in treating severe uveitis in patients with Behçet’s disease. The study aims to compare its effectiveness and safety to that of adalimumab in managing this condition.

What is already known about the treatment

  • Adalimumab

    Adalimumab is administered via subcutaneous injection and is currently used in clinical practice for various inflammatory conditions. It is being studied for its effectiveness in treating severe uveitis associated with Behçet’s disease. Adalimumab works by blocking a protein called tumor necrosis factor (TNF), which plays a role in inflammation. It is classified as a TNF inhibitor.

  • Tocilizumab

    Tocilizumab is given through intravenous infusion or subcutaneous injection and is approved for use in several autoimmune diseases. It is under investigation for its potential benefits in treating severe uveitis in Behçet’s disease. Tocilizumab acts by inhibiting the interleukin-6 (IL-6) receptor, which is involved in the inflammatory process. It belongs to the class of interleukin inhibitors.

Investigated diseases

Behçet's Disease – Behçet's disease is a rare, chronic condition that causes inflammation in blood vessels throughout the body. It can lead to a variety of symptoms, including mouth sores, genital sores, skin rashes, and eye inflammation. The disease often progresses with periods of flare-ups and remissions. Eye involvement, such as uveitis, can be particularly severe, potentially affecting vision. The exact cause of Behçet's disease is unknown, but it is believed to involve an abnormal immune response. The condition can vary greatly in severity and symptoms from person to person.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513371-41-00Protocol codeAPHP200007Estimated enrolment60 patientsSponsorAssistance Publique Hopitaux De Paris

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