Axial Involvement in Psoriatic Arthritis Cohort (AXIS)

• ClinicalTrials.gov Identifier: NCT04434885
• Recruitment Status: Recruiting
• First Posted: June 17, 2020
• Last Update Posted: June 27, 2022
• Sponsor: Charite University, Berlin, Germany
• Collaborators: Assessment of Spondyloarthritis International Society (ASAS); Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
• Information provided by (Responsible Party): Denis Poddubnyy, Charite University, Berlin, Germany

Tracking Information

• First Submitted Date: June 15, 2020
• First Posted Date: June 17, 2020
• Last Update Posted Date: June 27, 2022
• Actual Study Start Date: July 1, 2021
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 21, 2022)

The prevalence of axial involvement by local investigator [ Time Frame: Baseline ]

The frequency of axial involvement (global judgment) as assessed by the local investigator in PsA patients

Original Primary Outcome Measures (submitted: June 15, 2020)

The prevalence of axial involvement by local investigator [ Time Frame: Baseline ]

The prevalence of axial involvement as assessed by the local investigator in PsA patients presenting with peripheral involvement

Current Secondary Outcome Measures (submitted: June 21, 2022)

• The frequency of axial involvement by the central committee [ Time Frame: Baseline ]
  The frequency of axial involvement (global judgment) as assessed by the central clinical committee in PsA patients
• The frequency of imaging findings suggestive of axial involvement [ Time Frame: Baseline ]
  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

Original Secondary Outcome Measures (submitted: June 15, 2020)

• The prevalence of axial involvement by the central committee [ Time Frame: Baseline ]
  The prevalence of axial involvement as assessed by the central clinical committee in PsA patients presenting with peripheral involvement
• The frequency of imaging findings suggestive of axial involvement [ Time Frame: Baseline ]
  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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Axial Involvement in Psoriatic Arthritis Cohort
• Official Title: Axial Involvement in Psoriatic Arthritis Cohort
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Whole blood

• 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.
• Condition: Psoriatic Arthritis

Intervention

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

Study Groups/Cohorts

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).

Intervention: Other: Clinical and imaging examination of symptoms and signs suggestive of axial involvement

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 15, 2020): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

Contact: Denis Poddubnyy, MD; +4930450514582; denis.poddubnyy@charite.de

Contact: Dafna D. Gladman, MD, FRCPC; +14166035753; dafna.gladman@utoronto.ca

• Listed Location Countries: Canada, Germany

Administrative Information

• NCT Number: NCT04434885
• Other Study ID Numbers: AXIS
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

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

• Current Responsible Party: Denis Poddubnyy, Charite University, Berlin, Germany
• Original Responsible Party: Same as current
• Current Study Sponsor: Charite University, Berlin, Germany
• Original Study Sponsor: Same as current

Collaborators

• Assessment of Spondyloarthritis International Society (ASAS)
• Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Investigators

• Study Chair: Denis Poddubnyy, MD; Charite University, Berlin, Germany
• Study Chair: Dafna D. Gladman, MD, FRCPC; University of Toronto

• PRS Account: Charite University, Berlin, Germany
• Verification Date: June 2022