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, including a nested mechanistic sub-study

CTU03730 sites383 target enrollmentAugust 23, 2021

Overview

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35504634/ (added 04/05/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35772416/ (added 01/07/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38267107/ (added 25/01/2024)

Registry

who.int

Start Date

August 23, 2021

End Date

September 26, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

CTU0373

•1\. Aged \=18 years
•2\. Diagnosed with inflammatory conditions such as rheumatoid arthritis, psoriasis with or without arthritis, seronegative spondyloarthritis, reactive arthritis, atopic eczema, polymyalgia rheumatica, or systemic lupus erythematosus. This is not an exhaustive list and people with other inflammatory conditions where treatment may be interrupted for two weeks without the risk of a substantial increase in disease activity, or organ or life\-threatening flare up will also be eligible to participate in the study in order to increase the generalisability of the study.
•3\. Prescribed with oral or subcutaneous methotrexate (\=25 mg/week) \+/\- hydroxychloroquine weekly administered for at least the previous three months
•4\. Able to temporarily suspend methotrexate for two weeks in the opinion of patients’ consultant without the risk of substantial increase in disease activity, or organ or life\-threatening flare\-up
•5\. Able to give informed consent;
•6\. Eligible for planned booster vaccination for COVID\-19 (i.e. have received any 2 vaccinations from the original NHS COVID Vaccination Programme 2020/21\)

•Current participant exclusion criteria as of 08/03/2022:
•1\. Diagnosed with any of: ANCA associated vasculitis, large vessel vasculitis, myositis, giant cell arteritis, solid organ transplant or any another inflammatory condition for which treatment cannot be interrupted safely.
•2\. Treated with Rituximab drip in the last 18 months or planning to start it
•3\. Concurrent immune suppressive treatments in the last two months specifically leflunomide, ciclosporin, azathioprine or mercaptopurine, sulfasalazine or other 5\-amino\-salicylic acid drugs, mycophenolate, apremilast, or biologic agents
•4\. Radiotherapy or cancer chemotherapy in last six months
•5\. Prednisolone dose \>7\.5 mg/day within 30 days of randomisation
•6\. Active solid organ cancer (people with skin cancer or those cured of solid organ cancer are eligible)
•Previous participant exclusion criteria:
•1\. Diagnosed with inflammatory conditions for which treatment cannot be interrupted safely such as ANCA associated vasculitis, large vessel vasculitis, myositis, giant cell arteritis, or solid organ transplant
•2\. Treated with Rituximab drip in the last 18 months or planning to start it