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Axial Involvement in Psoriatic Arthritis Cohort (AXIS)

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ClinicalTrials.gov Identifier: NCT04434885
Recruitment Status : Not yet recruiting
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Collaborators:
Assessment of Spondyloarthritis International Society (ASAS)
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)
Information provided by (Responsible Party):
Denis Poddubnyy, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment
Psoriatic Arthritis 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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Axial Involvement in Psoriatic Arthritis Cohort
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04434885


Contacts
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Contact: Denis Poddubnyy, MD +4930450514582 denis.poddubnyy@charite.de
Contact: Dafna D. Gladman, MD, FRCPC +14166035753 dafna.gladman@utoronto.ca

Locations
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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Contact: Dafna D Gladman, MD, FRCPC         
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Contact: Denis Poddubnyy, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Assessment of Spondyloarthritis International Society (ASAS)
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)
Investigators
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Study Chair: Denis Poddubnyy, MD Charite University, Berlin, Germany
Study Chair: Dafna D. Gladman, MD, FRCPC University of Toronto
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Responsible Party: Denis Poddubnyy, Professor of Rheumatology, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04434885    
Other Study ID Numbers: AXIS
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases