AXIS (ASAS&GRAPPA)
Research type
Research Study
Full title
Axial Involvement in Psoriatic Arthritis Cohort (AXIS)
IRAS ID
308939
Contact name
Helena Marzo-Ortega
Contact email
Sponsor organisation
Leeds Teaching Hospital NHS Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Involvement of the axial skeleton is one of the relatively frequent manifestations associated with psoriatic skin disease along with involvement of peripheral musculoskeletal structure, which are usually referred to as psoriatic arthritis (PsA). Data from cohort studies suggest that up to 30% of patients with psoriasis develop PsA.
In general, axial involvement is poorly assessed in trials with PsA. The main reason for this is the lack of a widely accepted definition of axial involvement in PsA that could be used for research purposes. There is an urgent need for criteria and a unified and widely accepted nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients in the heterogeneous PsA population.
In 2018, ASAS and GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) agreed to develop a consensus definition of axial involvement in PsA to be used for research purposes. Systematic literature review and an online survey among ASAS and GRAPPA members was conducted in Dec 2018 – Jan 2019 to identify the most relevant variables relevant to deciding on the absence or presence of axial involvement in PsA. The four variables with the highest ranking were related to the objective signs of inflammatory changes in the axial skeleton on Radiographs or MRI.Currently,there is no PsA cohort in which a complete set of imaging is available in all patients. Therefore, we propose developing a prospective cross-sectional cohort through which classification criteria for axial involvement in PsA can be derived.
This is a multinational multicentre cross-sectional study in patients with a definite diagnosis of PsA. Eligible patients will be recruited prospectively in selected study centres and will undergo study-related examinations including imaging of the axial skeleton. These images will be evaluated locally and by the central imaging committee. Collected data will serve as a basis for the determination of the presence of axial involvement by the local investigator and, independently, by the central clinical study committee.
We plan to include a total of 400 patients with PsA in approximately 50 centres around the world. The maximal number of patients per study centre will be limited to 20.
The protocol of the AXIS and the primary study results will be published independently of the subsequent definition / classification criteria.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
22/WM/0047
Date of REC Opinion
5 Apr 2022
REC opinion
Further Information Favourable Opinion