British Axial Spondyloarthritis Inception Cohort
BAxSIC
2 other identifiers
observational
500
1 country
1
Brief Summary
The British Axial Spondyloarthritis Cohort (BAxSIC) study has been established under the auspices of the British Society for Spondyloarthritis (BRITSpA) in collaboration with the National Axial Spondyloarthritis Society (NASS) to provide real-world data to evaluate the impact of delay in diagnosis (from symptom onset to diagnosis) on work participation and functional outcomes and the natural history and impact of newly-diagnosed axial Spondyloarthritis, including disease activity, pain, fatigue, functional and work outcomes, comorbidities, therapies in the United Kingdom (UK). The study is a prospective cohort, enrolling patients attending rheumatology clinics in the UK who are newly diagnosed with axial Spondyloarthritis and naïve to biologic therapy. The study will run for an initial 3 year period commencing January 2023. Financial support was provided as a Research Grant from Pfizer Limited, UCB and Novartis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2022
CompletedFirst Posted
Study publicly available on registry
January 9, 2023
CompletedStudy Start
First participant enrolled
June 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2029
ExpectedJuly 18, 2023
July 1, 2023
2.6 years
November 24, 2022
July 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Work Productivity and Activity Impairment (WPAI)
Description of baseline characteristics of people with axSpA presenting to rheumatologists and the impact of delay in diagnosis (from symptom onset to diagnosis) on the baseline characteristics at presentation, measured by Work Productivity and Activity Impairment (WPAI).
Baseline to 12 months
Secondary Outcomes (1)
The Ankylosing Spondylitis Quality of Life index (ASQoL)
24months
Interventions
Observational inception cohort, with remote follow-up via participants and data record linkage
Eligibility Criteria
The study is a prospective cohort,enrolling patients attending rheumatology clinics in the UK who are newly diagnosed with axial Spondyloarthritis and naïve to biologic therapy.
You may qualify if:
- Aged ≥16 years.
- A physician diagnosis of axSpA (including ankylosing spondylitis) within the last 6 months prior to baseline.
- Willing and able to give informed consent to participate in the study.
You may not qualify if:
- Age \<16 years.
- Unable to communicate in English or are deemed, in any other way, to be unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chapel Allerton Hospital
Leeds, LS7 4SA, United Kingdom
Related Publications (1)
Weddell J, Harrison SR, Bennett AN, Gaffney K, Jones GT, Machado PM, Packham J, Sengupta R, Zhao SS, Siebert S, Marzo-Ortega H. British Axial Spondyloarthritis Inception Cohort (BAxSIC): a protocol for a multicentre real-world observational cohort study of early axial spondyloarthritis. Rheumatol Adv Pract. 2024 Jul 26;8(3):rkae087. doi: 10.1093/rap/rkae087. eCollection 2024.
PMID: 39165398DERIVED
Biospecimen
HLA-B27 (performed as part of routine clinical care)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helena Marzo-Ortega, MD/PhD
Leeds Teaching Hospital Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2022
First Posted
January 9, 2023
Study Start
June 9, 2023
Primary Completion
January 9, 2026
Study Completion (Estimated)
January 9, 2029
Last Updated
July 18, 2023
Record last verified: 2023-07