• Photo of COVID-19 vaccine vials.
    Vaccine Response On/Off Methotrexate Study

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?

INFO
Recruitment Progress:
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Latest participant recruited from: Harrogate and District NHS Foundation Trust (Open)
Date of most recent recruitment: Saturday, 5th March 2022