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Study on Methotrexate and Adalimumab for Non-Infectious Uveitis in Patients: Evaluating Effectiveness and Safety

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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 effectiveness and safety of treatments for a condition called non-infectious uveitis. Uveitis is an inflammation of the middle layer of the eye, which can lead to vision problems. The study will explore the use of two medications, Adalimumab and Methotrexate, either on their own or in combination. Adalimumab is a type of medication known as an immunoglobulin, which helps to reduce inflammation by targeting specific proteins in the immune system. Methotrexate is a chemical medication that also helps to control inflammation and is often used in autoimmune diseases.

The purpose of this study is to compare how well patients respond to these treatments over a period of time. Participants will be randomly assigned to one of three groups: one group will receive Adalimumab, another will receive Methotrexate, and the third group will receive a combination of both medications. The study will last for up to 52 weeks, during which participants will have regular visits to monitor their response to the treatment. The goal is to see if the treatments can help maintain a good clinical response, which means reducing the symptoms of uveitis and preventing flare-ups of inflammation.

Throughout the study, participants will be closely monitored to ensure their safety and to assess the cost-effectiveness of the treatments. The study will also look at various aspects of the participants' health and quality of life, such as changes in vision and any side effects experienced. By the end of the study, researchers hope to determine which treatment option is most effective for managing non-infectious uveitis.

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 is assigned to one of three groups: methotrexate alone, adalimumab alone, or a combination of both.

    The study focuses on treating non-infectious uveitis, which is an inflammation of the eye.

  2. Step 2

    Initial treatment phase

    Patients in the methotrexate group receive the medication orally. The dosage and frequency are determined by the study protocol.

    Patients in the adalimumab group receive the medication through an intramuscular injection. The dosage and frequency are determined by the study protocol.

    Patients in the combination group receive both methotrexate orally and adalimumab through an intramuscular injection. The dosage and frequency for both medications are determined by the study protocol.

  3. Step 3

    Monitoring and assessment

    Patients attend regular study visits to monitor their response to the treatment.

    The main goal is to achieve a good clinical response by week 16, which is maintained until week 52.

    Assessments include eye examinations and other tests to evaluate the effectiveness and safety of the treatment.

  4. Step 4

    Follow-up phase

    Patients continue to be monitored for any changes in their condition.

    The study aims to compare the effectiveness of the different treatment groups over time.

    Patients are assessed for any side effects or development of antibodies against adalimumab.

  5. Step 5

    Completion of the study

    The study is expected to conclude by September 2025.

    Final assessments are conducted to determine the overall effectiveness and safety of the treatments.

Who can join the trial?

19 criteria

  • Patients must have been diagnosed with **non-infectious uveitis** in at least one eye. Uveitis is an inflammation inside the eye.
  • Patients must be adults, meaning they are **18 years or older**.
  • Patients must have had at least one episode of active eye inflammation in the last 180 days before the start of the study. This can be shown by:
    • Active lesions in the retina or blood vessels in the eye.
    • Swelling in the central part of the retina, called **macular edema**, seen in an eye scan.
    • At least 2+ cells in the front part of the eye, which is a sign of inflammation.
    • At least 2+ cloudiness in the gel-like substance inside the eye, known as **vitreous haze**.
    • Patients must have active eye inflammation at the start of the study, shown by at least one of the following:
      • Active lesions in the retina or blood vessels in the eye.
      • Swelling in the central part of the retina, called **macular edema**, seen in an eye scan.
      • At least 1+ cells in the front part of the eye, which is a sign of inflammation.
      • At least 1+ cloudiness in the gel-like substance inside the eye, known as **vitreous haze**.
      • Patients must meet at least one of the following conditions:
        • Have a chronic condition needing special treatment without previous therapy required.
        • Have intermediate uveitis with both eyes affected and low vision or swelling in the central part of the retina.
        • Have uveitis that does not respond to steroid treatment, shown by ongoing inflammation despite treatment.
        • If female, patients must:
          • Be unable to have children, or
          • Be able to have children and agree to use birth control during the study and for 150 days after the last dose of study drugs.
          • Not be pregnant or breastfeeding.
          • Patients must have a negative test for **tuberculosis** (TB) and a normal chest X-ray. If they have a positive test or past TB exposure, they must be receiving or have completed preventive TB treatment.
          • Patients must be able and willing to sign a consent form and follow the study rules.
          • Patients must not be participating in another clinical trial.

Who cannot join the trial?

8 criteria

  • Patients with any type of infection in the eye.
  • Patients who have had eye surgery in the last 3 months.
  • Patients who are currently using certain medications that might interfere with the study.
  • Patients with other serious health conditions that could affect their participation.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

Methotrexate is a medication used in this trial to treat non-infectious uveitis. It works by suppressing the immune system to reduce inflammation in the eye, which can help prevent damage and improve vision. Adalimumab is another medication used in the trial for non-infectious uveitis. It is a type of drug known as a biologic, which targets specific parts of the immune system to decrease inflammation and help control symptoms of the disease. The trial also investigates the combination of Methotrexate and Adalimumab to see if using both medications together is more effective in treating non-infectious uveitis compared to using each medication alone. This combination therapy aims to provide better control of inflammation and improve patient outcomes.

What is already known about the treatment

  • Methotrexate

    Methotrexate is typically administered orally or by injection and is used in the treatment of various inflammatory conditions, including non-infectious uveitis. It is well-established in medical literature as an effective immunosuppressant. Methotrexate works by inhibiting the enzyme dihydrofolate reductase, which is crucial for DNA synthesis, thereby reducing the proliferation of immune cells. It is classified as an antimetabolite and antifolate drug.

  • Adalimumab

    Adalimumab is administered via subcutaneous injection and is used to treat inflammatory conditions such as non-infectious uveitis. It is widely recognized in medical literature as a biologic therapy. Adalimumab functions by blocking tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. It is classified as a TNF inhibitor.

Investigated diseases

Non-infectious uveitis – This is an inflammatory condition affecting the uvea, the middle layer of the eye, which includes the iris, ciliary body, and choroid. It is not caused by an infection and can result from autoimmune disorders, trauma, or exposure to toxins. Symptoms often include redness, pain, light sensitivity, and blurred vision. The inflammation can lead to complications such as cataracts, glaucoma, or retinal damage if not managed properly. The condition can be acute, lasting for a short period, or chronic, persisting for months or years. The progression of non-infectious uveitis varies, with some individuals experiencing recurrent episodes while others may have a single occurrence.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513123-17-00Estimated enrolment192 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Clinico San Carlos

sourced from the EU Clinical Trials Register and site verification

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