Inflammatory polyarthropathies, rheumatoid arthritis, psoriasis, seronegative spondyloarthritis, reactive arthritis, atopic eczema, polymyalgia rheumatica, systemic lupus erythematosus Musculoskeletal Diseases Inflammatory polyarthropathies, rheumatoid arthritis, psoriasis, seronegative spondyloarthritis, reactive arthritis, atopic eczema, polymyalgia rheumatica, systemic lupus erythematosus
Conditions
Interventions
Participants will be randomised into the two arms (experimental intervention or control intervention) in a 1:1 ratio using the minimisation factors:
1. Inflammatory condition type (inflammatory rheuma
Sponsors
CTU0373
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-spike receptor binding domain (RBD) antibody level measured from blood sample collected at 4 weeks post SARS-CoV-2 booster vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Level of anti-spike RBD antibody measured from blood sample collected at 12 weeks post booster vaccination 2. Patient assessments of disease activity measured using: 2.1. Global assessment using a numeric rating scale with one-week recall at baseline, 2, 4, and 12 weeks post booster vaccination 2.2. Current disease activity level and change since booster, 4 and 12 weeks post booster vaccination 3. Disease flare-up and actions taken to deal with them measured using patient self-report at 4 and 12 weeks post booster vaccination 4. Effect on quality of life measured using the EQ-5D-5L questionnaire at 4 and 12 weeks post booster vaccination 5. Adherence with advice to interrupt or continue methotrexate measured using patient self-report at 2 and 4 weeks post booster vaccination Mechanistic sub-study only: 1. COVID-19 neutralising titre measured from blood sample collected at 4 and 12 weeks post booster vaccination 2. Adherence to methotrexate allocation measured using patient self-report at 4 and 12 weeks post booster vaccination | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactJennifer Williams
Outcome results
None listed