Axial Involvement in Psoriatic Arthritis Cohort (AXIS)

This is a multinational multicenter cross-sectional study in patients with a definite diagnosis of PsA. The population of interest will consist of 400 adult patients diagnosed with PsA and fulfilling the classification criteria for PsA and not receiving biological or targeted synthetic disease modifying antirheumatic drugs (b or tsDMARDs). Participating rheumatologists are encouraged to include consecutive PsA patients not treated with biologic or a targeted synthetic disease-modifying antirheumatic drug because of their potential impact on active inflammatory changes in the axial skeleton, which will be the focus of the current study. Patients will be recruited prospectively in selected study centres and will undergo study-related examinations including imaging of the axial skeleton (X-rays and magnetic resonance imaging). Collected data will serve as a basis for the judgement on the presence or absence of axial involvement by the local investigator and, independently, by the central study committee.

Study Overview

• Status: Recruiting
• Conditions: Psoriatic Arthritis
• Intervention / Treatment: Other: Clinical and imaging examination of symptoms and signs suggestive of axial involvement

Detailed Description

Background. Involvement of the axial skeleton (of sacroiliac joints and / or spine) is one of the frequent manifestations associated with psoriatic skin disease along with involvement of peripheral musculoskeletal structures (peripheral arthritis, enthesitis, dactylitis), which are usually referred to as psoriatic arthritis (PsA). Depending on the definition used, the prevalence of axial disease varies from 25% to 70% of patients with PsA. There is an urgent need for an evidence-based definition 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.

Aim and study objectives. To develop a data-driven definition of axial involvement in PsA based on cross-sectional evaluation of patients with a diagnosis of PsA fulfilling the CASPAR criteria. The study objectives are: to determine the prevalence of axial involvement in a cohort of patients with PsA; to identify the frequency of imaging findings suggestive of inflammatory involvement of axial skeleton in PsA; to identify factors (clinical, lab, imaging) associated with the presence of axial involvement in PsA.

Study design and study population. This is a multinational multicenter cross-sectional study in patients with a definite diagnosis of PsA. The population of interest will consist of 400 adult patients diagnosed with PsA and fulfilling the classification criteria for PsA and not receiving biological or targeted synthetic disease-modifying antirheumatic drugs (b or tsDMARDs). Participating rheumatologists are encouraged to include consecutive PsA patients not treated with biologic or a targeted synthetic disease-modifying antirheumatic drug because of their potential impact on active inflammatory changes in the axial skeleton, which will be the focus of the current study. Patients will be recruited prospectively in selected study centres and will undergo study-related examinations including imaging of the axial skeleton (X-rays and magnetic resonance imaging). Collected data will serve as a basis for the judgement on the presence or absence of axial involvement by the local investigator and, independently, by the central study committee.

Analysis and study outcomes. The prevalence of axial involvement in a cohort of patients with PsA according to the local and central assessment will be calculated in PsA patients presenting with peripheral involvement (the primary analysis population) as well as in the entire group. The prevalence of axial involvement as assessed by the local investigator in PsA patients presenting with peripheral involvement will be the primary outcome of the study. The agreement between local and central judgements will be analyzed. A sub-analysis of a group presenting without peripheral involvement (i.e., pure axial disease) will be performed. The frequency of imaging findings (on MRI and X-rays) suggestive of inflammatory involvement of axial skeleton (sacroiliac joints and spine) in PsA according to the local and central assessment will be calculated. The agreement between local and central judgements will be analyzed. Parameters associated with the presence of axial involvement in PsA will be explored as well. The diagnostic / classification value of each parameter will be evaluated.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Denis Poddubnyy, MD; Phone Number: +4930450514582; Email: denis.poddubnyy@charite.de
• Study Contact Backup: Name: Dafna D. Gladman, MD, FRCPC; Phone Number: +14166035753; Email: dafna.gladman@utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Toronto Western Hospital
      • Contact: Dafna D Gladman, MD, FRCPC
• Germany
  • Berlin, Germany
    • Recruiting
    • Charite - Universitatsmedizin Berlin
    • Contact: Denis Poddubnyy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The population of interest will consist of consecutive adult patients diagnosed with PsA and fulfilling the CASPAR (ClASsification criteria for Psoriatic ARthritis) classification criteria for PsA with symptom duration of up to 10 years and not receiving biological or targeted synthetic disease modifying antirheumatic drugs (b or tsDMARDs). Participating rheumatologists are encouraged to include consecutive PsA patients not treated with biologic or a targeted synthetic disease-modifying antirheumatic drug because of their potential impact on active inflammatory changes in the axial skeleton, which will be the focus of the current study.

Description

Inclusion Criteria:

• Age >=18 years.
• Definite diagnosis of PsA.
• Fulfilment of the CASPAR criteria for PsA.
• Duration of PsA symptoms ≤10 years.
• Written informed consent.

Exclusion Criteria:

• Unable or unwilling to give informed consent or to comply with the protocol.
• Current or past treatment with biologic or a targeted synthetic disease-modifying antirheumatic drug (DMARDs).
• Contraindications for MRI and/or plain X-ray examination of sacroiliac joints and spine.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Psoriatic arthritis; Patients diagnosed with PsA and fulfilling the classification criteria for PsA with symptom duration of up to 10 years and not receiving biological or targeted synthetic disease modifying antirheumatic drugs (b or tsDMARDs).	Other: Clinical and imaging examination of symptoms and signs suggestive of axial involvement; Clinical and imaging examination including X-rays and magnetic resonance imaging of sacroiliac joints and spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of axial involvement by local investigator	The frequency of axial involvement (global judgment) as assessed by the local investigator in PsA patients	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of axial involvement by the central committee	The frequency of axial involvement (global judgment) as assessed by the central clinical committee in PsA patients	Baseline
The frequency of imaging findings suggestive of axial involvement	The frequency of imaging findings (on MRI and X-rays) suggestive of inflammatory involvement of axial skeleton (sacroiliac joints and spine) in PsA according to the local and central assessment	Baseline

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Assessment of Spondyloarthritis International Society (ASAS); Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)
• Investigators: Study Chair: Denis Poddubnyy, MD, Charite University, Berlin, Germany; Study Chair: Dafna D. Gladman, MD, FRCPC, University of Toronto

Publications and helpful links

General Publications

• Poddubnyy D, Baraliakos X, Van den Bosch F, Braun J, Coates LC, Chandran V, Diekhoff T, van Gaalen FA, Gensler LS, Goel N, Gottlieb AB, van der Heijde D, Helliwell PS, Hermann KGA, Jadon D, Lambert RG, Maksymowych WP, Mease P, Nash P, Proft F, Protopopov M, Sieper J, Torgutalp M, Gladman DD. Axial Involvement in Psoriatic Arthritis cohort (AXIS): the protocol of a joint project of the Assessment of SpondyloArthritis international Society (ASAS) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). Ther Adv Musculoskelet Dis. 2021 Dec 18;13:1759720X211057975. doi: 10.1177/1759720X211057975. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: AXIS (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study data will be made available for subsequent analysis upon reasonable request
• IPD Sharing Time Frame: After completion of the primary analysis
• IPD Sharing Access Criteria: Submission of a research proposal and approval by the study chairs
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No