Ongoing Clinical Trials for Giant Cell Arteritis
There are currently 16 clinical trials investigating new treatments and diagnostic approaches for Giant Cell Arteritis (also known as Horton’s Disease, temporal arteritis). These studies are taking place across multiple countries in Europe and are testing various medications including tocilizumab, secukinumab, methotrexate, and several other therapeutic approaches aimed at improving remission rates and reducing the need for long-term steroid treatment.
Clinical trial locations
- Austria
- Belgium
- Bulgaria
- Czechia
- Denmark
- Estonia
- Finland
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France
- Study on Stopping Tocilizumab for Patients with Giant Cell Arteritis
- Study Comparing Two Prednisone Treatment Plans for Patients with Giant Cell Arteritis
- Study of bosentan, prednisone and prednisolone in patients with newly diagnosed or relapsing giant cell arteritis
- Study of secukinumab and prednisone combination therapy for patients with giant cell arteritis (GCA): Evaluation of treatment effectiveness and safety
- Study on the Effectiveness of Tocilizumab, Methylprednisolone, and Prednisone for Patients with Acute Anterior Ischemic Optic Neuropathy in Giant Cell Arteritis
- Comparing Methotrexate and Tocilizumab for Treating Giant Cell Arteritis in Patients: A Study on Effectiveness and Safety
- Study on the Safety and Effectiveness of Upadacitinib and Prednisolone in Patients with Giant Cell Arteritis
- Study on Tocilizumab and Steroids for Patients with Giant Cell Arteritis and Cerebrovascular Involvement
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Germany
- Study of secukinumab and prednisone combination therapy for patients with giant cell arteritis (GCA): Evaluation of treatment effectiveness and safety
- Study on the Effectiveness and Safety of Secukinumab for Patients with New-Onset Giant Cell Arteritis in Clinical Remission
- Study on the Effectiveness of Abatacept for Patients with Giant Cell Arteritis
- Study on Methotrexate for Maintaining Remission in Patients with Giant Cell Arteritis After Initial Treatment with Tocilizumab and Glucocorticoids
- Greece
- Hungary
- Italy
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Netherlands
- PET/CT Imaging Study for Patients with Giant Cell Arteritis or Rheumatoid Arthritis Using Zirconium (89Zr) Crefmirlimab Berdoxam
- Study on [18F]Fluoro-PEG-Folate Imaging for Patients with Giant Cell Arteritis
- Study on the Safety and Effectiveness of Upadacitinib and Prednisolone in Patients with Giant Cell Arteritis
- Norway
- Poland
- Portugal
- Spain
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Sweden
- Study of RSV vaccines Arexvy and Abrysvo in patients with inflammatory rheumatic diseases receiving anti-rheumatic treatments
- Study of secukinumab and prednisone combination therapy for patients with giant cell arteritis (GCA): Evaluation of treatment effectiveness and safety
- Study on the Safety and Effectiveness of Upadacitinib and Prednisolone in Patients with Giant Cell Arteritis
PET/CT Imaging Study for Patients with Giant Cell Arteritis or Rheumatoid Arthritis Using Zirconium (89Zr) Crefmirlimab Berdoxam
This imaging study is being conducted in the Netherlands to evaluate a new diagnostic tool for patients with active disease. The study uses a special imaging technique called PET/CT combined with a tracer medication called 89Zr-Df-crefmirlimab.
Who can participate: Patients over 50 years old with newly diagnosed disease showing signs like fatigue, fever, weight loss, or headaches. Blood tests must show inflammation markers with ESR of 50 mm/hr or higher, or CRP of 10 mg/L or higher. Participants need to have imaging or biopsy results confirming the diagnosis.
Who cannot participate: People with other serious health conditions that might interfere with the study, those currently in another trial, those who had recent major surgery, pregnant or breastfeeding women, and individuals with uncontrolled high blood pressure or diabetes.
Study focus: The study aims to see how well this special imaging medication can highlight areas of inflammation in the arteries. Participants receive the tracer through an intravenous injection, then undergo a PET/CT scan. Researchers will measure how much of the medication is absorbed in different arteries, which could help develop better diagnostic tools for this condition.
Investigational drug: The medication being tested is 89Zr-Df-crefmirlimab, an imaging agent that helps doctors see specific immune cells called CD8 T cells during PET/CT scans.
Study on [18F]Fluoro-PEG-Folate Imaging for Patients with Giant Cell Arteritis
This Netherlands-based imaging study investigates how a substance called [18F]Fluor-PEG-Folate can help visualize inflammation in blood vessels.
Who can participate: Patients at least 50 years old with blood tests showing ESR of 50 mm/hr or higher, or CRP of 10 mg/L or higher. Participants must have symptoms like fatigue, fever, pain in limbs during activity, or shoulder and hip pain with morning stiffness. Imaging tests like ultrasound or FDG-PET/CT must show findings consistent with large vessel disease.
Who cannot participate: Those without the correct diagnosis or outside the specified age range, as well as vulnerable populations.
Study focus: The study evaluates how arteries absorb this imaging substance in patients with active disease and then again after nine months of standard treatment. Participants receive an injection of the imaging agent and undergo PET/CT scans at the beginning and end of the treatment period to compare results.
Investigational drug: [18F]fluor-PEG-folate is an imaging agent used in PET/CT scans to check disease activity levels before and after treatment.
Study on Stopping Tocilizumab for Patients with Giant Cell Arteritis
This French study explores different ways to stop tocilizumab treatment while minimizing the risk of disease returning.
Who can participate: Patients who have stopped corticosteroid treatment at least 12 weeks before joining, with good blood test results showing tolerance to tocilizumab. Participants must have a confirmed diagnosis with positive biopsy or imaging tests and be in remission for at least 12 weeks. They should have been treated with tocilizumab for 12 to 36 months and currently receiving 162 mg weekly injections.
Who cannot participate: Those with other serious health conditions, pregnant or breastfeeding women, people with recent infections requiring antibiotics, those receiving other investigational drugs, individuals with severe allergic reactions, cancer history (except certain skin cancers), uncontrolled high blood pressure, severe liver or kidney disease, recent live vaccine recipients, and those with alcohol or drug abuse history.
Study focus: The trial compares two approaches: stopping tocilizumab immediately versus gradually reducing it over 24 weeks. Participants are monitored for 26 weeks to see if they remain free from relapses while assessing their overall health and quality of life.
Investigational drug: Tocilizumab, a medication designed to reduce inflammation by blocking a protein that causes immune responses.
Study on the Effectiveness of Etanercept and Methotrexate for Patients with Giant Cell Arteritis
This Polish study compares two different treatments to see which is more effective in achieving long-lasting remission without steroids.
Who can participate: Patients at least 50 years old with a new or difficult-to-treat diagnosis. Active disease must be shown by symptoms and inflammation markers with ESR of 30 or more, or CRP of 10 or more. Women who can have children and sexually active men must agree to use effective birth control during and for six months after treatment.
Who cannot participate: Those with other serious health conditions, currently in another trial, recent infections, history of allergic reactions to study medications, pregnant or breastfeeding women, individuals with drug or alcohol abuse history, cancer diagnosis in the past five years, heart disease or stroke history, uncontrolled high blood pressure, and liver or kidney problems.
Study focus: The study evaluates whether etanercept or methotrexate can help patients achieve sustained remission without steroids over 104 weeks. Participants receive either medication via subcutaneous injection along with a tapering regimen of glucocorticoids.
Investigational drugs: Etanercept, which blocks a protein causing inflammation, and methotrexate, which suppresses the immune system to reduce inflammation.
Study on the Effects of Xenon and Oxygen on Brain Injury and Recovery in Patients with Aneurysmal Subarachnoid Hemorrhage in Intensive Care
This Finnish study investigates whether xenon gas can help protect the brain and improve recovery after a specific type of brain bleed. While this trial does not focus on the primary condition, it studies patients in intensive care with serious vascular problems.
Who can participate: Patients at least 18 years old with aneurysmal subarachnoid hemorrhage visible on imaging tests, deteriorated consciousness to Hunt-Hess grade 3-5, intubated patients with Glasgow Coma Scale score of 3-12. Treatment with xenon must start within 6 hours of symptom onset.
Who cannot participate: Those with uncontrolled serious infections, severe heart problems, recent stroke (past 6 months), severe liver or kidney disease, pregnant or breastfeeding women, known allergy to xenon, participation in another trial, mental health conditions interfering with study, and history of substance abuse.
Study focus: The study explores xenon’s potential to protect the brain and improve outcomes after brain hemorrhage. Participants receive xenon through inhalation alongside oxygen, with monitoring including MRI scans to evaluate brain condition.
Investigational drug: Xenon, a gas believed to protect the brain by blocking certain receptors involved in cell death, helping to preserve brain function.
Study Comparing Two Prednisone Treatment Plans for Patients with Giant Cell Arteritis
This French study compares a shorter 28-week prednisone treatment plan with a longer 52-week regimen to determine if the shorter course is equally effective.
Who can participate: Patients over 50 years old with a diagnosis based on specific clinical criteria including age, headache, and test results. Participants must have started oral corticosteroid therapy within the last 14 days, be registered with social security, and provide written consent.
Who cannot participate: Those without the diagnosis, people outside the specified age range, and vulnerable populations.
Study focus: The trial randomly assigns participants to either a 28-week or 52-week prednisone treatment plan. Researchers monitor various health indicators including blood pressure, weight, blood sugar levels, and bone density to assess the safety and effectiveness of each approach. The main goal is to see if patients achieve complete remission without relapse by the end of the study period.
Investigational drug: Prednisone (cortisone), a corticosteroid used to reduce inflammation.
Study of bosentan, prednisone and prednisolone in patients with newly diagnosed or relapsing giant cell arteritis
This French trial evaluates whether adding bosentan treatment for three months helps patients already receiving standard corticosteroid therapy.
Who can participate: Patients at least 50 years old at disease onset with blood tests showing ESR of 50 or higher or CRP of 20 or higher. Participants must have symptoms like new headaches, scalp tenderness, jaw pain, vision problems, or muscle pain with stiffness. A positive temporal artery biopsy or imaging evidence of blood vessel inflammation is required, along with active disease signs within 4 weeks before the study. Women must be menopausal or use effective non-hormonal birth control with a negative pregnancy test.
Who cannot participate: Those under 18, previous bosentan treatment recipients, people with known allergies to study medications, active serious infections, severe liver disease, pregnancy or breastfeeding, recent trial participation, inability to follow study procedures, uncontrolled high blood pressure, heart failure, active cancer or recent cancer treatment, severe kidney disease, incompatible medication users, mental conditions interfering with participation, and recent drug or alcohol abuse.
Study focus: The study monitors whether patients can reduce their corticosteroid dose according to a planned schedule while keeping their condition under control when bosentan is added to treatment. The treatment period with bosentan lasts 16 weeks, while corticosteroid treatment continues for up to 52 weeks, with follow-up extending to two years.
Investigational drugs: Bosentan, which helps blood vessels relax and widen by blocking specific receptors, and glucocorticoids, which reduce inflammation by suppressing the immune system’s inflammatory response.
Study of RSV vaccines Arexvy and Abrysvo in patients with inflammatory rheumatic diseases receiving anti-rheumatic treatments
This Swedish study evaluates how anti-rheumatic treatments affect the body’s response to RSV vaccination in patients with inflammatory rheumatic diseases.
Who can participate: Patients 60 years or older who are regularly followed at a rheumatology department and receiving immunomodulating treatment for at least 3 months, including methotrexate, biological treatments, or JAK inhibitors. Written consent is required.
Who cannot participate: Those with active respiratory infections, previous severe vaccine allergic reactions, pregnancy or breastfeeding, current participation in other trials, recent immunoglobulin or blood product treatment (past 3 months), immunodeficiency disorders, recent live vaccine administration (past 4 weeks), severe uncontrolled chronic conditions, active infection requiring antibiotics, high-dose corticosteroid use (more than 10mg prednisone daily), known RSV vaccine allergy, history of severe vaccination reactions, active cancer or ongoing cancer treatment, and inability to comply with study procedures.
Study focus: Participants receive one dose of RSV vaccine through intramuscular injection. Blood samples are taken before and 3-6 weeks after vaccination to measure immune response. The study will help healthcare providers understand how these treatments influence vaccine effectiveness.
Investigational drugs: Two RSV vaccines (Arexvy and Abrysvo) are used, along with various anti-rheumatic medications including methotrexate, anti-TNF medications, anti-IL6r medications, anti-CD20 medications, and JAK inhibitors.
Study of secukinumab and prednisone combination therapy for patients with giant cell arteritis (GCA): Evaluation of treatment effectiveness and safety
This large multinational study across 17 European countries tests whether secukinumab combined with a shorter prednisone treatment course works better than using a longer prednisone treatment alone.
Who can participate: Patients at least 50 years old who can communicate with the study team and follow requirements. Participants must have a diagnosis confirmed by being at least 50 at diagnosis, history of high inflammation markers (ESR ≥30 or CRP ≥10), clear symptoms like headaches or vision problems, and positive biopsy or imaging tests. Active disease within 6 weeks before study start is required, shown by symptoms and inflammation markers. Participants must be able to safely take prednisone at 20-60 mg daily. Those taking methotrexate must be on a stable dose for at least 4 weeks.
Who cannot participate: Those with active or chronic infections including tuberculosis, HIV, or hepatitis; cancer history within past 5 years (except certain skin cancers); pregnant or breastfeeding women; severe heart conditions or uncontrolled high blood pressure; severe allergic reactions to medications; current biological medication treatment; severe kidney or liver problems; mental health conditions interfering with participation; live vaccine recipients within 6 weeks before study start; previous trial participation; alcohol or drug abuse within past 6 months; any condition making the patient unsuitable; inability to follow procedures; and other investigational drug treatment within 30 days before starting.
Study focus: Participants receive either secukinumab (150mg or 300mg) or placebo injections under the skin, along with prednisone treatment. One group takes prednisone for 26 weeks while another takes it for 52 weeks. The total study duration is 52 weeks, with monitoring for symptom improvement, energy levels, overall well-being, and treatment-related health issues.
Investigational drugs: Secukinumab, which targets and blocks a protein involved in inflammation, and glucocorticoids used in a gradually decreasing dose alongside the main treatment.
Study on the Effectiveness and Safety of Secukinumab for Patients with New-Onset Giant Cell Arteritis in Clinical Remission
This German study investigates whether secukinumab can delay symptom return in patients with new-onset disease who are currently in remission.
Who can participate: Patients at least 50 years old who can communicate with the study team and follow requirements. Participants must have a new diagnosis within 6 weeks of first study visit, confirmed by being at least 50 at disease start, history of high inflammation markers linked to active disease, clear symptoms, and positive temporal artery biopsy or blood vessel inflammation evidence on imaging tests. Patients must be in remission with no relapses at study start and taking prednisolone or equivalent at 20-60 mg daily.
Who cannot participate: Those not in clinical remission, not eligible for glucocorticoid-monotherapy treatment, without new-onset diagnosis, unable to follow the prednisolone taper regimen, and vulnerable populations.
Study focus: The study monitors how long it takes for symptoms to return, if they do, while assessing overall health and quality of life. Participants receive either secukinumab 300 mg or placebo through subcutaneous injection, along with prednisolone following a tapering regimen according to treatment guidelines. The primary goal is achieving sustained remission at Week 52.
Investigational drugs: Secukinumab, which inhibits interleukin-17A (a protein involved in inflammation), and prednisolone, a glucocorticoid used in a tapering regimen.
Study on the Effectiveness of Abatacept for Patients with Giant Cell Arteritis
This German and Italian study investigates whether abatacept can help achieve remission in patients with newly diagnosed or relapsing disease.
Who can participate: Patients with newly diagnosed or relapsing disease showing active symptoms within the past 8 weeks. Participants must be willing to follow all treatment and follow-up procedures and provide written informed consent. Those who can become pregnant or cause pregnancy must use effective birth control methods including abstinence, surgical sterilization, barrier methods, or hormonal contraception.
Who cannot participate: Those unable to provide informed consent, individuals with allergic reactions to abatacept, pregnant or breastfeeding women, people with active tuberculosis, those with latent tuberculosis who cannot take preventive treatment, severe infections within the last 3 months, hepatitis B or C, HIV infection, cancer history in past 5 years (except certain skin cancers), severe heart/liver/kidney disease, those taking medications that might interact with the study drug, live vaccine recipients within 3 months before starting, and other trial participants.
Study focus: Participants receive either abatacept or placebo along with standard glucocorticoid treatment. During the 12-month study period, participants are monitored for disease remission, treatment safety, and effects on quality of life. The study also assesses participants’ ability to stop taking glucocorticoids while maintaining remission.
Investigational drugs: Abatacept (CTLA4-Ig), which modifies the immune system response causing inflammation, and placebo for comparison.
Summary
The 16 clinical trials for Giant Cell Arteritis represent a comprehensive research effort across Europe, with France leading with 8 trials, followed by Germany with 4 trials, and multiple other countries participating in large multinational studies. The research demonstrates several important trends in treatment development.
Several trials focus on reducing long-term steroid dependence by testing alternative medications or shorter treatment regimens. Studies in France and Germany are comparing different durations of prednisone treatment (28 weeks versus 52 weeks) to determine if shorter courses can be equally effective. Other trials investigate whether adding medications like bosentan, secukinumab, or abatacept to standard treatment can help patients maintain remission while reducing steroid use.
A significant focus exists on maintaining remission after initial treatment success. Multiple studies examine whether medications like methotrexate or tocilizumab can help keep the disease under control after initial improvement with standard therapy. These maintenance studies, particularly in Germany and France, aim to find strategies that prevent disease flare-ups while minimizing medication side effects.
Several innovative diagnostic imaging studies in the Netherlands are testing new ways to visualize inflammation in blood vessels using PET/CT scans with specialized tracers. These imaging trials could lead to better disease monitoring and earlier detection of treatment response.
Large multinational trials involving up to 17 countries are testing newer biological medications like secukinumab and upadacitinib. These studies represent significant international collaboration and suggest these medications may become important future treatment options if proven effective.
Specialized research includes a French trial focusing on patients with vision problems from the disease, testing whether tocilizumab can improve eye health outcomes. Another study in Sweden examines how RSV vaccines work in patients receiving various anti-rheumatic treatments, which is important for protecting vulnerable patients from respiratory infections.
The geographical concentration of trials in Western European countries reflects both the disease prevalence in older populations and the presence of established rheumatology research networks in these regions. The variety of approaches being tested demonstrates the medical community’s commitment to finding more effective treatments with fewer side effects for this serious condition affecting primarily elderly patients.
