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Study on Adjusting Adalimumab Treatment for Patients with Chronic Non-Infectious Uveitis

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 a condition called chronic non-infectious uveitis, which is an inflammation of the eye that is not caused by an infection. The treatment being tested in this study is a medication called adalimumab, which is commonly used to reduce inflammation in various conditions. Adalimumab will be administered as a solution for injection, either in a pre-filled syringe or a pre-filled pen.

The purpose of the study is to evaluate a new strategy for using adalimumab in patients with chronic non-infectious uveitis who have already achieved a complete response to treatment. The study will compare a new approach, which involves adjusting the timing of adalimumab doses based on monitoring drug levels in the body, to the usual way of giving the medication. The goal is to see if this new approach can maintain the patients' eye health and prevent infections over a period of 48 weeks.

Participants in the study will receive adalimumab injections and will be monitored regularly to assess their eye health and check for any signs of infection. The study will also look at the quality of life of participants and the cost-effectiveness of the treatment. This trial aims to provide valuable information on whether adjusting the dosing schedule of adalimumab based on drug levels can offer better outcomes for patients with chronic non-infectious uveitis.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes verifying that the patient has chronic non-infectious uveitis and has achieved a complete ophthalmological response for at least 48 weeks.

    The patient must have been on a stable dose of adalimumab 40 mg every 14 days for at least 24 weeks and not have received systemic corticosteroid therapy for at least 12 weeks.

  2. Step 2

    Treatment phase

    The patient will continue receiving adalimumab 40 mg via subcutaneous injection. The frequency of administration may be adjusted based on therapeutic drug monitoring (TDM) to evaluate the effectiveness of the treatment.

    The goal is to maintain a complete ophthalmological response and prevent infections over a period of 48 weeks.

  3. Step 3

    Monitoring and evaluation

    Regular monitoring will occur at weeks 0, 12, 24, 36, and 48. This includes checking for anti-adalimumab antibodies and measuring quality of life using the National Eye Institute Visual Functioning Questionnaire-25.

    The primary endpoint is to maintain a complete ophthalmological response and absence of infection at week 48.

  4. Step 4

    Completion and follow-up

    At the end of the 48-week period, the patient's response to the treatment will be evaluated to determine the overall effectiveness and safety of the therapeutic strategy.

    The trial aims to demonstrate the benefits of adjusting adalimumab administration based on TDM compared to a conventional approach.

Who can join the trial?

7 criteria

  • Must be a member or beneficiary of a social security scheme.
  • Must have received detailed information about the study and signed a consent form with the investigator to participate.
  • Must be an adult, which means being 18 years or older.
  • Must have a diagnosis of chronic non-infectious uveitis in at least one eye. Uveitis is an inflammation inside the eye, and "non-infectious" means it's not caused by an infection.
  • Must have had a complete response to eye treatment for at least 48 weeks. For those with uveitis related to Behçet's disease, the response must be for at least 96 weeks. A complete response means the eye condition has improved significantly.
  • Must have been on a medication called ADA (40mg every 14 days) for at least 24 weeks. This allows the medication to reach a stable level in the body.
  • Must not have received systemic corticosteroid therapy for at least 12 weeks. Systemic corticosteroids are medications that reduce inflammation and are taken by mouth or injection, affecting the whole body.

Who cannot join the trial?

4 criteria

  • Patients who have not achieved a complete response to treatment. A complete response means that the symptoms of the condition have fully improved.
  • Patients who have an infection. An infection is when harmful germs enter the body and cause illness.
  • Patients who are not within the specified age range for the study. The age range is the specific ages that are allowed to participate.
  • Patients who belong to a vulnerable population. This means groups of people who might need special protection or care.
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Investigated drugs

Adalimumab: This medication is used to treat chronic non-infectious uveitis, which is an inflammation of the eye. In this clinical trial, the role of adalimumab is to help maintain a complete ophthalmological response, meaning it helps keep the eye inflammation under control. The trial is exploring a strategy to adjust the frequency of adalimumab doses based on therapeutic drug monitoring, which involves checking the levels of the drug in the blood to ensure the best possible treatment outcome.

What is already known about the treatment

Adalimumab – Adalimumab is administered via subcutaneous injection. It is currently used in medicine for treating various inflammatory conditions and is well-documented in medical literature. The main therapeutic indication for this trial is chronic non-infectious uveitis. At the molecular level, adalimumab works by blocking tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. It is classified as a TNF inhibitor, which helps reduce inflammation and prevent disease progression.

Investigated diseases

Noninfectious Uveitis – This is an inflammatory condition affecting the uvea, the middle layer of the eye, which is not caused by an infection. It can lead to redness, pain, light sensitivity, and blurred vision. The inflammation can affect one or both eyes and may involve other parts of the eye, such as the retina or optic nerve. The condition can be acute, with sudden onset, or chronic, with long-lasting symptoms. Over time, it may cause complications like cataracts, glaucoma, or vision loss if not managed properly. The progression of symptoms can vary, with periods of flare-ups and remissions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509733-39-00Protocol code23PH187Estimated enrolment320 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

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