Active not recruitingPHASE3INTERVENTIONAL

MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial

This study looks into Giant Cell Arteritis (GCA), a condition causing inflammation in blood vessels, which mainly affects people over 50. Current treatment often involves high doses of steroids (prednisone) for a long time, leading to unwanted side effects. Researchers are comparing two other medications, tocilizumab and methotrexate, to see if they can reduce the need for long-term steroids. The study wants to know if methotrexate is just as good, or "non-inferior," to tocilizumab in preventing GCA symptoms from returning over 18 months. It's also exploring if methotrexate could be a more cost-effective option for the NHS. Participants will receive either methotrexate or tocilizumab, alongside some prednisone, and will have regular check-ups, blood tests, and questionnaires.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Centre Hospitalier Universitaire Dijon

Enrolment target

230

Start

27 Jan 2020

Estimated completion

01 Jan 2027

Giant Cell Arteritis

What is this study about?

Giant Cell Arteritis (GCA) is a condition where the body's immune system mistakenly attacks its own blood vessels, causing them to become inflamed. This inflammation can lead to a variety of symptoms, including headaches, pain in the jaw when chewing, tenderness in the scalp, and sometimes even vision problems. Many people with GCA also feel generally unwell, experiencing tiredness, weight loss, and fever. The most common treatment for GCA relies on steroid medications like prednisone, which are very effective at calming the inflammation. However, these steroids often need to be taken for a long time, sometimes up to two years, and can lead to side effects such as bone thinning, weight gain, and an increased risk of infections. Managing these side effects is a big challenge for both patients and doctors.

Because of the side effects associated with long-term steroid use, doctors are always looking for other treatments that can keep GCA under control while allowing patients to reduce their steroid dose. This study focuses on two such medications: tocilizumab and methotrexate. Tocilizumab has previously shown promise in helping GCA patients reduce their steroid intake and keeping the condition in remission. However, it is an expensive drug, and about 40% of patients find their symptoms return within six months of stopping it. Methotrexate, another medication, has also been shown to help reduce the risk of GCA coming back when used alongside steroids.

This research aims to compare these two treatments – tocilizumab and methotrexate – directly. The main question is whether a 12-month course of methotrexate is as effective as a 12-month course of tocilizumab in preventing GCA flare-ups over an 18-month period. Researchers also want to understand the economic impact of using methotrexate compared to tocilizumab, as methotrexate is generally a less expensive option. By taking part in this study, you would be helping doctors understand the best way to treat GCA, potentially improving the lives of many people with this condition in the future.

Key takeaways

This study compares two GCA treatments: methotrexate and tocilizumab.
It aims to find if methotrexate is as good as tocilizumab in preventing GCA flare-ups.
The goal is to reduce long-term steroid use and its side effects.
Participation involves regular clinic visits, blood tests, and questionnaires.
The study also looks at the cost-effectiveness of the treatments.
All participants will receive some prednisone alongside the study drug.

Who may be eligible?

To be considered for this study, you must be at least 50 years old and have a confirmed diagnosis of Giant Cell Arteritis (GCA). This diagnosis needs to be current, meaning your GCA has been active within the last six weeks, as shown by blood tests or current symptoms. Your GCA diagnosis would typically be confirmed by your doctor based on standard criteria, which might include specific symptoms like new headaches, jaw pain, or vision issues, and often involves a biopsy of a temporal artery or scans showing inflammation in major blood vessels.

There are also some reasons why you wouldn't be able to join the study. For example, if you are pregnant or a pre-menopausal woman (meaning you haven't had your menopause yet), you would not be eligible. Also, patients with certain uncontrolled mental health conditions, those who are unable to give their consent, or individuals who may not be able to follow the study's instructions reliably (non-compliant) cannot participate. Additionally, there are weight restrictions: you must weigh between 40 and 100 kilograms to take part. Further medical conditions or treatments might also exclude you, so it's important to discuss your full medical history with the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 50 years old or older?
Have you been diagnosed with active Giant Cell Arteritis (GCA) in the last six weeks?
Are you able to provide your written consent to participate?
Are you between 40kg and 100kg in weight?
Are you a post-menopausal woman (or a man)?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be randomly assigned to receive either methotrexate or tocilizumab, alongside an existing steroid treatment (prednisone). This means that neither you nor your doctor will get to choose which study drug you receive. You will take the assigned medication for 12 months.

Your participation will involve regular visits to the clinic for check-ups, which might include having questionnaires to fill out about your symptoms and how you are feeling, and blood samples taken for monitoring your condition and the effects of the treatment. These assessments will help the study team keep track of your health and the progress of the GCA. The study will monitor you for a total of 18 months, even after you finish taking the study medication. The specific number of visits and tests will be explained to you in detail by the study team.

Potential risks and benefits

By participating in this study, you could potentially benefit from close medical monitoring and access to treatments that might help manage your GCA more effectively, possibly reducing your need for long-term high-dose steroids. However, as with any medication, there are potential risks and side effects associated with methotrexate, tocilizumab, and prednisone. The study team will explain these in detail so you can make an informed decision. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CHU de Dijon
Verified postcode
Dijon, France

Common questions

What is Giant Cell Arteritis (GCA)?

GCA is a condition where your body's immune system attacks and inflames your blood vessels, particularly those in your head and neck, but also larger ones like the aorta.

What is prednisone, and why is it used?

Prednisone is a type of steroid medication commonly used to quickly reduce inflammation in GCA. However, it can have side effects if taken for a long time.

What are methotrexate and tocilizumab?

These are two different medications that can help control GCA and reduce the need for high doses of prednisone. This study is comparing them.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to either methotrexate or tocilizumab, meaning it's decided by chance, like flipping a coin.

How long will the study last if I join?

You will take the study medication for 12 months, and then be monitored for an additional 6 months, making the total study period 18 months.