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VROOM Study Home Page

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

Welcome to the VROOM study website!

Please see below for an animated video of the final results of the study.

You can go to the 'News' page above for versions of the video subtitled in different languages.

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?

Study Organisation & Funding
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The VROOM study was conducted by a research team led by Professor Abhishek, a Consultant Rheumatologist, and Professor Rosemary Boyton, a leading scientist in infection. The study was supported by a nationally accredited Clinical Trial Unit called the Oxford Clinical Trials Research Unit (OCTRU), based at the University of Oxford.

The study was funded by the National Institute for Health Research and is sponsored by the University of Nottingham.

Latest News
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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. 

19 December 2023

We are pleased to announce that the VROOM study has been published in The Lancet Rheumatology journal. To read the article, please click here. 

05 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. 

Recruitment Progress:

560
383

Date of latest recruit:

5 March, 2022

Site of latest recruit:

VROOM - Harrogate and District NHS Foundation Trust
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VROOM Study

Botnar Research Centre
Windmill Road
Headington
Oxford
OX3 7LD

Chief Investigator

Prof. Abhishek Abhishek

Abhishek.abhishek@nottingham.ac.uk

Approval References

REC Reference: 21/YH/0209

IRAS: 303827

ISRCTN11442263

Contacts

Email: vroom@ndorms.ox.ac.uk

OCTRU Trials Hub tel:
01865 223 469

VROOM Trial Team free phone:
0808 196 2101