Axial Involvement in Psoriatic Arthritis Cohort

NCT ID: NCT04434885

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-12-31

Brief Summary

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.

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.

Conditions

Psoriatic Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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).

Clinical and imaging examination of symptoms and signs suggestive of axial involvement

Intervention Type: OTHER

Clinical and imaging examination including X-rays and magnetic resonance imaging of sacroiliac joints and spine

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assessment of Spondyloarthritis International Society (ASAS)

UNKNOWN

Sponsor Role: collaborator

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

NETWORK

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Denis Poddubnyy

Professor of Rheumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denis Poddubnyy, MD

Role: STUDY_CHAIR

Charite University, Berlin, Germany

Dafna D. Gladman, MD, FRCPC

Role: STUDY_CHAIR

University of Toronto

Locations

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status: RECRUITING

Countries

Canada; Germany

Central Contacts

Denis Poddubnyy, MD

Role: CONTACT

denis.poddubnyy@charite.de

+4930450514582

Dafna D. Gladman, MD, FRCPC

Role: CONTACT

dafna.gladman@utoronto.ca

+14166035753

Facility Contacts

Dafna D Gladman, MD, FRCPC

Role: primary

Denis Poddubnyy, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 34987619 (View on PubMed)

Other Identifiers

AXIS

Identifier Type: -

Identifier Source: org_study_id