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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 study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Pomeranian Medical University Szczecin Poland

Other Sites

Site Name City Country Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
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Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Dolnoslaski Szpital Specjalistyczny Im. T.Marciniaka-Centrum Medycyny Ratunkowej Wroclaw Poland
Spbwnrt Ssxuczahuvgvmom Ixbfmwgrjuq W Kzxovqwv Cracow Poland
Pexunhppz Ifwkpwal Mfsdalfc Mtyqlbtyldsq Smbdr Wiypbdnnnaky I Azgxswrpelwxg Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Recruiting
15.04.2024

Trial locations

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.

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 ID:
2023-506623-29-01
Protocol code:
ABM/EFFECTA/2023
Trial Phase:
Therapeutic exploratory (Phase II)

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