Rheumatoid arthritis Musculoskeletal Diseases
Conditions
Interventions
The MOOSE trial aims to compare the clinical and cost-effectiveness of subcutaneous and oral methotrexate in adults with rheumatoid arthritis (RA) and to collect information about the acceptability of
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Meets American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA 3. Active RA defined as at least one swollen joint assessed by a rheumatologist 4. Willing to initiate methotrexate 5. RA not treated with methotrexate previously 6. Disease Activity Score 28-joints including C reactive protein (DAS-28-CRP) =2.6 (blood test from initial clinic visit to be used to calculate this score at baseline visit)
Exclusion criteria
Exclusion criteria: 1. RA previously treated with other disease-modifying anti-rheumatic drugs. Patients treated with hydroxychloroquine for palindromic RA or autoantibody-positive arthralgia are eligible. 2. Psoriasis or other immune-mediated inflammatory conditions such as inflammatory bowel disease, ankylosing spondylitis, lupus, polymyalgia rheumatica or giant cell arteritis 3. Dementia, severe psychological disturbance i.e. mental health illness that makes receiving study information and initial screening questions a stressful experience, 4. Unable to give informed consent or comply with study procedures 5. Cancer treatment i.e. surgery, radiotherapy, immunotherapy or chemotherapy in the last 12 months; (current or past non-metastatic melanoma and skin cancer are eligible). 6. Solid organ transplant on long-term daily prednisolone and/or other immunosuppressive treatments 7. Stage 4/5 chronic kidney disease (CKD), chronic liver disease (e.g. autoimmune hepatitis, primary sclerosing cholangitis, hepatitis B or C, cirrhosis); low-dose methotrexate contraindicated 8. Pregnant or breastfeeding 9. Planning to become pregnant or breastfeed within the next 18 months 10. For men, intending to start a family within the next 18 months 11. Life expectancy less than 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission of rheumatoid arthritis (RA), defined as DAS-28-CRP <2.6, at 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The following endpoint evaluations will coincide with clinic visits and questionnaires completed at 4, 8 12, 24 and 52 weeks after commencing the trial and starting methotrexate treatment: 1. Remission of rheumatoid arthritis (RA) at 12 and 52 weeks, defined as DAS-28-CRP <2.6 2. Remission of RA at 12, 24 and 52 weeks, as per 2022 Boolean American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) definition, Simplified Disease Activity Index 3. Disease activity at 12, 24 and 52 weeks, defined as DAS-28-CRP, Clinical Disease Activity Index, Simplified Disease Activity Index and components of these scores 4. Response to treatment at 12, 24 and 52 weeks, defined as DAS-28-CRP; EULAR and ACR 20, 50, 70 responses 5. Function measured using HAQ-DI at 12, 24 and 52 weeks 6. Quality of life, fatigue, anxiety, and depression measured using RA-QoL, FACIT-F, GAD-7, PHQ-8, and EQ-5D-5L at weeks 24 and 52 7. Work productivity and employment measured using WPAI at 24 and 52 weeks 8. Cost-effectiveness of subcutaneous over oral methotrexate measured using service utilisation at week 52 9. Treatment acceptability assessed using qualitative interviews, BMQ and TFAQ at 4-8 weeks and 24-32 weeks | — |
Countries
United Kingdom
Outcome results
None listed