Vaccine Response On/off Methotrexate (VROOM): does temporarily suspending methotrexate treatment for two weeks enhance COVID-19 vaccine response?

You may be able to take part if you are 18 or older and have an inflammatory condition, such as rheumatoid arthritis, psoriasis, reactive arthritis, eczema, or lupus. You must have been taking a weekly dose of methotrexate (25 mg or less) for at least three months, and you must be eligible for an NHS COVID-19 booster jab. Crucially, your specialist doctor must agree that pausing your medicine for two weeks will not put your health at risk.

You will not be able to join if you have certain severe conditions where stopping treatment could be unsafe, such as blood vessel inflammation (vasculitis) or having had an organ transplant. You will also be excluded if you take other strong immune-suppressing drugs, take high doses of steroid tablets (prednisolone), or have had chemotherapy or radiotherapy in the past six months.

If you join the study, a computer will randomly place you into one of two groups. One group will continue taking methotrexate as normal, while the other group will stop taking it for two weeks immediately after having their COVID-19 booster. You will be asked to attend three hospital appointments over several weeks. At each visit, the research team will take a small blood sample to check your antibody levels and ask questions about your general health. If your condition flares up while off methotrexate, your medical team will provide your usual NHS care and treatments without delay. The study runs over roughly three to four months of follow-up for each participant.