Axial Involvement in Psoriatic Arthritis Cohort

NCT04434885 | Unknown

• 1 other identifier: AXIS
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 2

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.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The frequency of axial involvement by the central committee

  Baseline

• The frequency of imaging findings suggestive of axial involvement

  Baseline

Study Arms (1)

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

Interventions

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

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

Psoriatic arthritis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Assessment of Spondyloarthritis International Society (ASAS): collaborator
• Group for Research and Assessment of Psoriasis and Psoriatic Arthritis: collaborator

Study Sites (2)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 34987619 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Denis Poddubnyy, MD

  Charite University, Berlin, Germany

  STUDY CHAIR

• Dafna D. Gladman, MD, FRCPC

  University of Toronto

  STUDY CHAIR

Central Study Contacts

Denis Poddubnyy, MD

CONTACT

+4930450514582; denis.poddubnyy@charite.de

Dafna D. Gladman, MD, FRCPC

CONTACT

+14166035753; dafna.gladman@utoronto.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: July 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion of the primary analysis
• Access Criteria: Submission of a research proposal and approval by the study chairs

Locations

CA (1); DE (1)