Welcome to the VROOM study website!
Please note - the VROOM study has now closed to recruitment.
Full study title: A multi-centre randomised controlled trial examining the effects of temporarily suspending low-dose methotrexate treatment for two weeks after SARS-CoV-2 vaccine booster on vaccine response in immunosuppressed adults with inflammatory conditions and nested mechanistic study.
PURPOSE OF THE STUDY
You may already know that methotrexate is used to treat inflammatory conditions such as rheumatoid arthritis and psoriasis. It often controls the condition, but it may also reduce the body’s ability to fight infections. People who take methotrexate are known to have weaker responses to vaccines against the seasonal flu and pneumonia than those not on methotrexate.
A recent study in Korea showed that a two week break in taking methotrexate after the flu vaccine increased the body’s immune response to it. However, it is not known if such an interruption in methotrexate treatment would improve the protection provided by vaccines against COVID-19. Because there is no clear evidence on whether to temporarily stop methotrexate around the time of COVID-19 vaccinations, specialists across the world have given conflicting advice.
The VROOM study aims to find out if we should stop or continue methotrexate around the time of COVID-19 booster vaccine.
We also need to understand if there is a possible downside to temporarily stopping methotrexate, in the control of your disease. Potentially it could mean you get an increase in symptoms/disease activity, which people often call flares. If the benefit of pausing methotrexate is very small – is it better to continue taking your methotrexate as normal to prevent having issues with the control of your disease?
The University of Nottingham is organising this study. It is being conducted by a research team led by Professor Abhishek, a Consultant Rheumatologist, and Professor Rosemary Boyton, a leading scientist in infection. The study is also being supported by a nationally accredited Clinical Trial Unit called the Oxford Clinical Trials Research Unit (OCTRU), based at the University of Oxford.
The study has been funded by the National Institute for Health Research and is sponsored by the University of Nottingham.
The VROOM study has now closed to recruitment.
To hear about the study from one of the study's doctors - watch a short video about it by clicking here.
5 April 2023
The VROOM study has been mentioned in the latest edition of COVID-19: The Green Book issued by the UK Health Security Agency. To read the relevant chapter, please follow the link here.
26 January 2022
The NIHR (National Institute for Health and Care Research) has issued an alert summarizing the initial findings of the VROOM study here: A pause in methotrexate treatment boosted the immune response to the COVID-19 vaccine.
12 July 2022
News Item 2
What has the VROOM study found so far? A lay summary of the initial findings is now available, please click here to read.
News Item 1
The interim results from the VROOM study have been published in The Lancet Respiratory Medicine Journal. The article is free for everyone to read, please click here to read the full article. A lay summary of the initial results is available here.
We hope to enrol 560 adults aged 18 years or older who have inflammatory conditions such as rheumatoid arthritis, psoriasis and psoriatic arthritis into this study. We will recruit from at least 20 NHS hospitals or centres providing NHS care.
Those who take part also need to have received the first two COVID-19 vaccinations.
To find out what would be involved if you chose to take part, including the potential benefits and risks, click here.
*Please note - the VROOM study has now closed to recruitment.*
