British Axial Spondyloarthritis Inception Cohort (BAxSIC): a protocol for a multicentre real-world observational cohort study of early axial spondyloarthritis

Jake Weddell; Stephanie R. Harrison; Alexander N. Bennett; Karl Gaffney; Gareth T. Jones; Pedro M. Machado; Jonathan Packham; Raj Sengupta; Sizheng Steven Zhao; Stefan Siebert; Helena Marzo-Ortega

doi:10.1093/rap/rkae087

British Axial Spondyloarthritis Inception Cohort (BAxSIC): a protocol for a multicentre real-world observational cohort study of early axial spondyloarthritis

Jake Weddell
, Stephanie R. Harrison
, Alexander N. Bennett
, Karl Gaffney
, Gareth T. Jones
, Pedro M. Machado
, Jonathan Packham
, Raj Sengupta
, Sizheng Steven Zhao
, Stefan Siebert
, Helena Marzo-Ortega^* (Corresponding Author)

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

1 Downloads (Pure)

Abstract

Objectives: Timely diagnosis remains a challenge in axial SpA (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, multicentre, observational study. Eligible participants are adults (≥16 years of age), with a physician-confirmed diagnosis of axSpA in the 6 months prior to study entry, recruited from secondary and tertiary rheumatology centres in the UK. Participants will be followed up for 3 years, with in-person visits at baseline and 24 months. In addition, patient self-reported assessments will be recorded remotely via the online electronic case report form (eCRF) at 6, 12, 18, 30 and 36 months. Results: The first patient was enrolled in BAxSIC in June 2023. Recruitment is currently ongoing and is planned to end in June 2026. Initial results will be available in 2027. Since opening, the trial has undergone two protocol amendments. 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.

Original language	English
Article number	rkae087
Number of pages	9
Journal	Rheumatology Advances in Practice
Volume	8
Issue number	3
Early online date	26 Jul 2024
DOIs	https://doi.org/10.1093/rap/rkae087
Publication status	Published - 2024

Data Availability Statement

Anonymized study data can be made available to other academic researchers upon reasonable request, subject to the approval of the BAxSIC Data Access Committee, which will consist of the TMG and include clinical and patient representation.

Supplementary material is available at Rheumatology Advances in Practice online.

Funding

The BAxSIC study is supported by research grants from Novartis, Pfizer and UCB. There has been no input with regards to study design or analysis.

Keywords

axial spondyloarthritis
diagnostic delay
inception cohort
rheumatology
virtual follow-up

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Cite this

Weddell, J., Harrison, S. R., Bennett, A. N., Gaffney, K., Jones, G. T., Machado, P. M., Packham, J., Sengupta, R., Zhao, S. S., Siebert, S., & Marzo-Ortega, H. (2024). British Axial Spondyloarthritis Inception Cohort (BAxSIC): a protocol for a multicentre real-world observational cohort study of early axial spondyloarthritis. Rheumatology Advances in Practice, 8(3), Article rkae087. https://doi.org/10.1093/rap/rkae087

Weddell, J, Harrison, SR, Bennett, AN, Gaffney, K, Jones, GT, Machado, PM, Packham, J, Sengupta, R, Zhao, SS, Siebert, S & Marzo-Ortega, H 2024, 'British Axial Spondyloarthritis Inception Cohort (BAxSIC): a protocol for a multicentre real-world observational cohort study of early axial spondyloarthritis', Rheumatology Advances in Practice, vol. 8, no. 3, rkae087. https://doi.org/10.1093/rap/rkae087

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abstract = "Objectives: Timely diagnosis remains a challenge in axial SpA (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, multicentre, observational study. Eligible participants are adults (≥16 years of age), with a physician-confirmed diagnosis of axSpA in the 6 months prior to study entry, recruited from secondary and tertiary rheumatology centres in the UK. Participants will be followed up for 3 years, with in-person visits at baseline and 24 months. In addition, patient self-reported assessments will be recorded remotely via the online electronic case report form (eCRF) at 6, 12, 18, 30 and 36 months. Results: The first patient was enrolled in BAxSIC in June 2023. Recruitment is currently ongoing and is planned to end in June 2026. Initial results will be available in 2027. Since opening, the trial has undergone two protocol amendments. 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.",

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author = "Jake Weddell and Harrison, \{Stephanie R.\} and Bennett, \{Alexander N.\} and Karl Gaffney and Jones, \{Gareth T.\} and Machado, \{Pedro M.\} and Jonathan Packham and Raj Sengupta and Zhao, \{Sizheng Steven\} and Stefan Siebert and Helena Marzo-Ortega",

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AU - Bennett, Alexander N.

AU - Gaffney, Karl

AU - Jones, Gareth T.

AU - Machado, Pedro M.

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AU - Sengupta, Raj

AU - Zhao, Sizheng Steven

AU - Siebert, Stefan

AU - Marzo-Ortega, Helena

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N2 - Objectives: Timely diagnosis remains a challenge in axial SpA (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, multicentre, observational study. Eligible participants are adults (≥16 years of age), with a physician-confirmed diagnosis of axSpA in the 6 months prior to study entry, recruited from secondary and tertiary rheumatology centres in the UK. Participants will be followed up for 3 years, with in-person visits at baseline and 24 months. In addition, patient self-reported assessments will be recorded remotely via the online electronic case report form (eCRF) at 6, 12, 18, 30 and 36 months. Results: The first patient was enrolled in BAxSIC in June 2023. Recruitment is currently ongoing and is planned to end in June 2026. Initial results will be available in 2027. Since opening, the trial has undergone two protocol amendments. 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.

AB - Objectives: Timely diagnosis remains a challenge in axial SpA (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, multicentre, observational study. Eligible participants are adults (≥16 years of age), with a physician-confirmed diagnosis of axSpA in the 6 months prior to study entry, recruited from secondary and tertiary rheumatology centres in the UK. Participants will be followed up for 3 years, with in-person visits at baseline and 24 months. In addition, patient self-reported assessments will be recorded remotely via the online electronic case report form (eCRF) at 6, 12, 18, 30 and 36 months. Results: The first patient was enrolled in BAxSIC in June 2023. Recruitment is currently ongoing and is planned to end in June 2026. Initial results will be available in 2027. Since opening, the trial has undergone two protocol amendments. 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.

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ER -

British Axial Spondyloarthritis Inception Cohort (BAxSIC): a protocol for a multicentre real-world observational cohort study of early axial spondyloarthritis

Abstract

Data Availability Statement

Funding

Keywords

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