Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Methotrexate as Remission Maintenance Therapy after Remission-Induction Therapy with Tocilizumab and Glucocorticoids in Subjects with Giant Cell Arteritis

This research study is for people with giant cell arteritis, a condition that causes inflammation in blood vessels. The main goal is to see if a drug called methotrexate can help keep the illness under control once it has settled down after initial treatment. Participants will have already received other treatments, including tocilizumab and steroid medicines. They will then be given either methotrexate or a dummy treatment (placebo). Researchers will carefully watch how long it takes for the illness to return over a 12-month period. They will also look at how much steroid medicine is needed and how the illness affects people's daily lives. This is a Phase II study, meaning it's an early-stage trial exploring how well the treatment works.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Rheinische Friedrich Wilhelms Universität Bonn

Enrolment target

Start

12 Aug 2022

Giant cell arteritis

What is this study about?

This study is designed for individuals who have giant cell arteritis (GCA), a condition where the body's immune system attacks blood vessels, causing inflammation. If you have GCA, you likely know it can lead to symptoms like headaches, jaw pain, or even vision problems. The good news is that there are treatments to get the inflammation under control, often involving medicines like tocilizumab and steroids.

Once the active inflammation has settled down (this is called 'remission'), doctors want to find the best way to keep it from flaring up again. This study is testing whether a medicine called methotrexate can help maintain this state of remission. Methotrexate is a drug that helps to calm down an overactive immune system. Participants in this study will have already gone through an initial period of treatment to get their GCA under control.

The main aim of the study is to see if taking methotrexate after the initial treatment helps to prevent GCA from returning for a longer period, compared to taking a dummy treatment (placebo). Researchers will follow participants closely for 12 months, checking for any signs that the GCA is coming back. They'll also look at how much steroid medication people need and how the treatment affects their general well-being and quality of life. The findings from this study will help doctors understand if methotrexate is a good option for keeping GCA in remission long-term.

Key takeaways

This study evaluates methotrexate to keep giant cell arteritis in remission.
It's for people whose GCA is already under control after initial treatment.
Participants will receive either methotrexate or a dummy treatment for 12 months.
Researchers will monitor how long people stay well and how much steroid medicine is needed.
This is an early-stage trial (Phase II) exploring treatment effectiveness.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. Both men and women can take part.

The study is specifically for people who have been diagnosed with giant cell arteritis. You must have already completed an initial treatment plan, which included tocilizumab and steroid medications, and your condition should now be in remission (meaning the symptoms are under control).

There might be other health requirements or previous treatments that would affect whether you can join, so the study team will ask detailed questions about your health history to make sure your participation is safe and appropriate for the research.

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 18 years old or older?
Do you have a confirmed diagnosis of giant cell arteritis?
Has your GCA recently been brought under control with tocilizumab and steroid treatment?
Are you able to attend regular clinic appointments for 12 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either methotrexate or a dummy treatment (placebo) after your initial GCA treatment has brought your condition into remission. Neither you nor your study doctor will know which treatment you are receiving. The study will last for 12 months, during which time you will attend regular clinic visits. At these visits, doctors will monitor your GCA symptoms, check your overall health through examinations and possibly blood tests, and ask about your general well-being.

They'll keep a close eye on any signs that your GCA might be returning and how much steroid medicine you need. There may also be questionnaires for you to complete about how you are feeling and how GCA impacts your daily life. The total duration of your active involvement in the treatment part of the study is 12 months, but there might be some follow-up beyond that, potentially for up to 18 months in total.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as contributing to new knowledge about giant cell arteritis and possibly receiving close monitoring of your health. While methotrexate is a known medicine, like all medications, it carries potential risks and side effects, which the study team will explain fully. Taking a placebo means you wouldn't receive the active study drug. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is giant cell arteritis?

It's an illness where blood vessels, usually in the head, become inflamed. It can cause headaches, jaw pain, and problems with vision.

What is methotrexate?

Methotrexate is a medicine that helps to calm down an overactive immune system, which can reduce inflammation in conditions like giant cell arteritis.

What does 'remission' mean?

Remission means that your illness is currently under control and your symptoms have largely settled down.

What is a placebo?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the real drug's effects.

How long will the study last?

The main treatment part of the study will last for 12 months, with some potential follow-up visits after that.