Inflammatory arthritis Musculoskeletal Diseases
Conditions
Interventions
The study aims to recruit 438 patients with stable inflammatory arthritis from approximately 30 centres from varied demographic areas in the UK.
Patients will primarily be approached during their ro
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 years or over 2. Diagnosis of inflammatory arthritis (RA, PsA, axSpA, undifferentiated arthritis) for at least 2 years 3. Stable disease: defined as a level of disease control that the physician feels is suitable for PIFU; on the same conventional, targeted synthetic or biologic DMARD(s), or no treatment, for at least the previous 3 months; and with no escalation in therapy planned 4. Able to contact the Rheumatology team when required 5. Suitable for PIFU in the opinion of their consultant 6. Willing and able to give consent and comply with study procedures
Exclusion criteria
Exclusion criteria: 1. Currently or previously on PIFU for inflammatory arthritis 2. Safeguarding/consent/capacity concerns (using General Medical Council guidance) 3. Health literacy concerns from the treating clinician related to inflammatory arthritis 4. Women who are pregnant or planning to start a family 5. Currently undergoing radiotherapy, immunotherapy or chemotherapy for malignancy 6. Patients on end-of-life care pathways
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome(s) as of 21/04/2026: Musculoskeletal quality of life is measured using MSK-HQ at 24 months. _____ Previous primary outcome(s): Musculoskeletal quality of life is measured using MSK-HQ score over 24 months (measured at baseline, months 6, 12, 18 and 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 21/04/2026: 1. Musculoskeletal quality of life is measured using MSK-HQ over 24 months. 2. Musculoskeletal quality of life is measured using MSK-HQ at 6, 12 & 18 months. 3. Overall health-related quality of life is measured using EQ-5D-5L and EQ-VAS scores at baseline, months 12 and 24. 4. Incremental cost measured using patient health resource use and costs at baseline, months 6, 12, 18 and 24. 5. Incremental cost measured using hospital-reported health resource use and costs at 12 months prior to baseline through month 24 6. Cost-effectiveness measured using Cost per quality-adjusted life year (QALY) gained over the 24-month time horizon 7. Progression from no treatment to first-line DMARD measured using the proportion of patients starting a first-line DMARD during the study 8. Progression from conventional drugs to biologic therapies measured using the proportion of patients starting a first biologic during the study 9. Disease activity is measured using disease-specific activity score (CDAI, DAS28-CRP, ASDAS, DAPSA) at baseline and 24 months 10. Disease activity is measured using the number of patient-reported flares from baseline to 24 months 11. Disease activity is measured using the number of hospital-reported flares from baseline to 24 months 12. Patient efficacy is measured using perceived efficacy in patient-physician interactions (PEPPI) score at baseline and 24 months 13. Depression is measured using PHQ-4 score at baseline and 24 months 14. Acceptability of PIFU to patients is measured using qualitative methods at Weeks 2-12 and Months 16-24. 15. Acceptability of PIFU health professionals/service providers is measured using qualitative methods once the site has been open to recruitment for at least 12 months _____ Previous key secondary outcome(s): 1. Musculoskeletal quality of life is measured using MSK-HQ score at baseline, months 6, 12, 18 and 24 2. Overall health-related quality of life is measured using E | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactLaura Coates
Outcome results
None listed