Abstract
Objectives
Timely diagnosis remains a challenge in axial Spondyloarthritis (axSpA). In addition, data are scarce on the impact of diagnostic delay and disease progression in affected individuals. The British Axial Spondyloarthritis Inception Cohort (BAxSIC) study aims to investigate the impact of newly diagnosed axSpA, the natural history of the disease and the effect of diagnostic delay on disease outcomes.
Methods
BAxSIC is a prospective, multi-centre, observational study. Eligible participants are adults (aged 16 years old or over), with a physician-confirmed diagnosis of axial Spondyloarthritis in the six months prior to study entry, recruited from secondary and tertiary rheumatology centres in the United Kingdom (UK). Participants will be followed up for 3 years, with in-person visits at baseline and 24 months. In addition, patient self-reported assessments (PROMs questionnaires) will be recorded remotely via the online electronic case report form (eCRF) at 6, 12, 18, 30 and 36 months.
Conclusion
The BAxSIC study is the first inception cohort designed to investigate the impact of diagnostic delay on clinical presentation and long-term functional outcomes in patients with axSpA in the UK. With an innovative, patient-led virtual longitudinal data collection model, data generated from this study will help inform and improve the care of people newly diagnosed with axSpA.
Trial status
The first patient was enrolled in BAxSIC in June 2023, with recruitment planned to end in June 2026. Since opening, the trial has undergone two protocol amendments. BAxSIC has been registered with clinicaltrials.gov (NCT05676775).
Timely diagnosis remains a challenge in axial Spondyloarthritis (axSpA). In addition, data are scarce on the impact of diagnostic delay and disease progression in affected individuals. The British Axial Spondyloarthritis Inception Cohort (BAxSIC) study aims to investigate the impact of newly diagnosed axSpA, the natural history of the disease and the effect of diagnostic delay on disease outcomes.
Methods
BAxSIC is a prospective, multi-centre, observational study. Eligible participants are adults (aged 16 years old or over), with a physician-confirmed diagnosis of axial Spondyloarthritis in the six months prior to study entry, recruited from secondary and tertiary rheumatology centres in the United Kingdom (UK). Participants will be followed up for 3 years, with in-person visits at baseline and 24 months. In addition, patient self-reported assessments (PROMs questionnaires) will be recorded remotely via the online electronic case report form (eCRF) at 6, 12, 18, 30 and 36 months.
Conclusion
The BAxSIC study is the first inception cohort designed to investigate the impact of diagnostic delay on clinical presentation and long-term functional outcomes in patients with axSpA in the UK. With an innovative, patient-led virtual longitudinal data collection model, data generated from this study will help inform and improve the care of people newly diagnosed with axSpA.
Trial status
The first patient was enrolled in BAxSIC in June 2023, with recruitment planned to end in June 2026. Since opening, the trial has undergone two protocol amendments. BAxSIC has been registered with clinicaltrials.gov (NCT05676775).
| Original language | English |
|---|---|
| Article number | rkae087 |
| Journal | Rheumatology Advances in Practice |
| DOIs | |
| Publication status | Published - 26 Jul 2024 |
Keywords
- Axial spondyloarthritis
- rheumatology
- diagnostic delay
- inception cohort
- virtual follow-up