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Study on the Effectiveness of Etanercept and Methotrexate for Patients with Giant Cell Arteritis

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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 two treatments for giant cell arteritis, a condition that causes inflammation of the blood vessels, often in the head. The treatments being compared are etanercept and methotrexate. Etanercept is a medication that is injected under the skin and is used to reduce inflammation by blocking a protein in the body that causes immune responses. Methotrexate is also injected under the skin and works by interfering with the growth of certain cells in the body, including those that cause inflammation. Additionally, folic acid is used in the study to help reduce the side effects of methotrexate.

The purpose of the study is to compare how well these treatments can help patients achieve a long-lasting remission from giant cell arteritis without the need for steroids, which are often used to control inflammation. The study will involve participants receiving either etanercept or methotrexate over a period of time, with regular check-ups to monitor their health and the effectiveness of the treatment. Some participants may also receive a placebo, which is a substance with no active medication, to help compare the results.

Throughout the study, participants will be monitored for any changes in their condition, including improvements or any side effects. The study aims to provide valuable information on which treatment is more effective in managing giant cell arteritis and helping patients achieve remission without relying on steroids. This research could lead to better treatment options for those affected by this condition.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    You will take background medications as part of the treatment. these include folic acid, which is taken by mouth at a dose of 15 mg, prednisone, which is taken by mouth at a dose of 60 mg, or methylprednisolone, which is taken by mouth at a dose of 48 mg.

    You will receive one of two different study treatments. the first option is etanercept, which is administered via injection under the skin at a dose of 50 mg. the second option is methotrexate, which is administered via injection under the skin at a dose of 25 mg.

  2. Step 2

    Monitoring and evaluation

    During the trial, your condition will be monitored for remission, which means a state where the symptoms of giant cell arteritis (an inflammation of the blood vessels) are no longer present and inflammatory markers (blood tests that show levels of inflammation) return to normal.

    Your progress will be evaluated at several intervals, specifically at 24, 26, 52, 78, and 104 weeks from the start of the study.

  3. Step 3

    Long-term follow-up

    The study continues for up to 104 weeks to observe the long-term effectiveness of the assigned treatment and to monitor for any complications or adverse events (side effects or unexpected medical issues).

Who can join the trial?

8 criteria

  • You must provide your written informed consent, which means you agree to take part in the study after being fully informed about its details.
  • You must be 50 years of age or older.
  • You must have a confirmed diagnosis of giant cell arteritis, which is an inflammation of the lining of your arteries.
  • If the disease only affects arteries outside the skull, your diagnosis must be confirmed by imaging, such as an ultrasound (using sound waves to see inside), CT scan (using X-rays), MRI (using magnets), angiography (using X-rays to see blood vessels), or PET-CT (a specialized scan to see body function).
  • The disease must be newly diagnosed, refractory (meaning it does not respond well to standard treatments), or relapsing (meaning symptoms have returned after a period of improvement).
  • You must have active disease, which means you are currently experiencing symptoms caused by the inflammation rather than permanent damage from the past.
  • You must show signs of inflammation in your blood through tests called ESR (a test that measures how quickly red blood cells sink to the bottom of a tube) or CRP (a test that measures a specific protein produced by the body during inflammation).
  • Women who are able to become pregnant, and men who are sexually active with women who can become pregnant, must agree to use effective contraception (methods to prevent pregnancy) during the study and for at least 6 months after finishing the treatment.

Who cannot join the trial?

24 criteria

  • You cannot participate if you have ischemia, which means a lack of blood flow to vital organs like your brain, heart, lungs, kidneys, or digestive system, caused by the disease.
  • You are excluded if you have moderate or severe heart failure (a condition where the heart cannot pump blood well enough to meet the body's needs), unstable heart disease, or if you have had a stroke (sudden loss of blood flow to the brain) or a myocardial infarction (a heart attack) within the last 6 months.
  • You cannot join if you have severe liver dysfunction (serious problems with how your liver works) or severe renal impairment (serious problems with how your kidneys work).
  • You are excluded if you have bone marrow hypoplasia, which is a condition where your bone marrow does not produce enough new blood cells.
  • You cannot participate if you have any other severe disease in your breathing, nervous, hormone, digestive, or urinary systems that makes joining the study too risky.
  • You are excluded if you have had malignancy (cancer) within the last 5 years, unless it was a specific type of skin cancer that was completely removed and has not returned for at least 12 months.
  • You cannot join if your blood tests show low levels of WBC (white blood cells that fight infection), NEU (neutrophils, a type of white blood cell), HGB (hemoglobin, a protein in red blood cells that carries oxygen), or PLT (platelets, which help blood clot).
  • You are excluded if your blood tests show low HGB, high liver enzymes like ALT or AST, high total bilirubin (a substance produced by the liver), or a low eGFR (a measurement used to check how well your kidneys filter waste).
  • You cannot participate if you test positive for HBsAg (Hepatitis B), anti-HBc (Hepatitis B antibody), anti-HCV (Hepatitis C antibody), anti-HIV (HIV antibody), or have a positive Quantiferon-TB Gold test (a test for tuberculosis).
  • Women who are pregnant or have a positive pregnancy test cannot participate.
  • You are excluded if you have used certain medications recently, such as high doses of oral corticosteroids (steroid medicines used to reduce inflammation) within 2 weeks, or specific immune-system medicines like methotrexate or TNFα inhibitors within 12 weeks.
  • You cannot join if you have used immunoglobulins (antibodies used as medicine) or other strong immune-suppressing drugs within the last 6 months.
  • You are excluded if you have a history of drug, alcohol, or psychoactive substance abuse or addiction.
  • You cannot participate if you have another chronic autoimmune rheumatic disease, which is a long-term condition where the immune system attacks the body's own tissues, such as lupus or rheumatoid arthritis.
  • You are excluded if you have received live or attenuated vaccinations (vaccines that use a weakened form of a germ) within the last 3 months or plan to get one during the study.
  • You cannot join if you have used other investigational drugs (medicines being tested in studies) within the last 12 weeks.
  • You are excluded if you are breastfeeding or plan to breastfeed during the study.
  • You cannot participate if you are unable to cooperate with the study requirements.
  • You are excluded if you have oral mucous ulcers (sores inside the mouth) or an active stomach or duodenal ulcer (sores in the lining of the stomach or the first part of the small intestine).
  • You cannot join if you have a history of demyelinating syndrome, which is a condition where the protective covering of nerve cells is damaged.
  • You are excluded if you have had a major organ transplant (such as a kidney, lung, heart, or liver transplant).
  • You cannot participate if you have had major surgery within the last 3 months or plan to have surgery during the study.
  • You are excluded if you have a hypersensitivity (an allergic reaction) to methotrexate, etanercept, or any of the other ingredients used in those medicines.
  • You cannot join if you have an acute, recurrent, or chronic infection, such as tuberculosis or HIV, that makes participating too risky.
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Investigated drugs

  • Etanercept

    is a medication given by injection under the skin. In this study, it is being tested to see how well it helps achieve long-term remission from the disease without needing to use steroids.

  • Methotrexate

    is a medication given by injection under the skin. It is being used as a comparison treatment to evaluate its effectiveness against etanercept in helping patients reach remission.

  • Folic acid

    is a vitamin taken by mouth. It is used as background therapy to support patients during the trial.

  • Prednisone

    is a steroid medication taken by mouth. It is used as background therapy to manage the patient's condition.

  • Methylprednisolone

    is a steroid medication taken by mouth. It is used as background therapy to manage the patient's condition.

What is already known about the treatment

  • Methotrexate

    This medication is an antimetabolite used to treat various inflammatory conditions and is administered via an injection under the skin. It is a well-established treatment in medical practice that works by interfering with the production of certain molecules necessary for cell growth and division. By slowing down the rapid multiplication of immune cells, it helps reduce inflammation in the body.

  • Folic Acid

    This is a vitamin used as a nutritional supplement and is taken orally as a pill. It is widely used in medicine to support healthy cell function and prevent certain deficiencies. At a molecular level, it helps the body produce and use the building blocks needed for DNA and cell repair.

  • Prednisone

    This is a corticosteroid medication that is taken orally to manage various inflammatory and autoimmune diseases. It is a commonly used substance in clinical settings that works by suppressing the body's immune response and reducing swelling. It achieves this by modulating the activity of cells that trigger inflammation.

  • Methylprednisolone

    This medication is a type of steroid that is administered orally to treat a range of inflammatory conditions. It is a standard medical treatment known for its ability to quickly calm an overactive immune system. It works at a molecular level to block the chemical signals that cause inflammation and swelling in the body.

  • Etanercept

    This is a biological medication that is administered through an injection under the skin to treat immune system disorders. It is a recognized therapy that functions by acting as a decoy to intercept specific proteins that cause inflammation. By binding to these proteins, it prevents them from triggering the inflammatory response in the body.

Investigated diseases

Giant cell arteritis - This condition involves inflammation of the lining of the arteries, most commonly those in the head. The inflammation typically affects medium or large-sized arteries. As the disease progresses, the swelling can cause the artery walls to thicken and narrow. This narrowing can reduce blood flow to vital organs or tissues. Symptoms may fluctuate or worsen over time if the inflammation is not controlled.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506623-29-01Protocol codeABM/EFFECTA/2023Estimated enrolment88 patientsSponsorAgencja Badań Medycznych

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