British Axial Spondyloarthritis Inception Cohort
ConditionAxial Spondyloarthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-50
SponsorThe Leeds Teaching Hospitals NHS Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Age <16 years.
Unable to communicate in English or are deemed, in any other way, to be unable to give informed consent
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervenetion
Other interventionObservational inception cohort, with remote follow-up via participants and data record linkage
Treatment groups
No treatment groups listed
Trial outcomes
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).
Time frame
Baseline to 12 monthsSecondary outcomes
1
The Ankylosing Spondylitis Quality of Life index (ASQoL)
The Ankylosing Spondylitis Quality of Life index (ASQoL) is a validated disease-specific 18-item questionnaire, that has been developed specifically for measuring health-related quality of life (HRQoL) in subjects with AS. The ASQoL has been used and has shown to be responsive in. The ASQoL score ranges from 0 to 18 with a higher score indicating worse HRQoL.
Time frame
24monthsSponsors and contacts
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Source ClinicalTrials.gov