Ankylosing Spondylitis Registry of Ireland


Objectives

The primary objective is to measure the burden of AS in the population in primary and secondary care and to identify early predictors of a poor outcome.

The secondary objective is to collect biological samples (serum and DNA) from participants to participate in international studies examining the genetic influence on disease aetiology and to examine within SIRAS whether genetic and serological factors predict poor outcome.


Background

A similiar Database has already been established in Scotland and Northern Ireland under the supervision of Prof G McFarlane (University of Dundee). It is the intention to commence a similar database here in the Republic of Ireland. The ASRI database will therefore document all AS patients attending Rheumatology clinics in Ireland. It will be used to study outcome measures as well as responses to therapy. The identification of factors that might predict a poor prognosis will be a major area research focus.

This database will record patient demographics, treatment including biologic therapy and outcomes. The primary objective is to measure the burden of AS in the population, primary and secondary care. We would then establish an inception cohort in order to identify early predictors of a poor outcome.


Study Design

  1. All patients with a clinical diagnosis of AS and who have had a consultation within secondary care within the past three years will be registered irrespective of whether they are taking biologics.
  2. Nurses in the individual regional centres (approx. 10 hospitals) will enter information directly on to the web-based database system. Quarterly updates will be provided to ensure that the regional centres have entered all their data. Data will be collected on an annual basis.
  3. Standard outcome measures for AS patients.on biologics will be used as in the initial assessment form e.g BASDAI, BASFI,BASMI, SPINAL VAS, CRP and ESR.
  4. We also plan to ask participating patients to provide biologic samples. This will allow ASRI to contribute samples to an international collaboration examining genetic infleunces on AS and to analyse our data on outcome (and responses to therapy) utilising this genetic information.
  5. If SAEs in patients on biologic therapy are recorded on the database this will be reported to the company within 24hrs and follow up information made available as appropriate.