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Identification of New Prognostic Markers in Psoriatic Arthritis

Primary Purpose

Psoriasis, Psoriatic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Serum Markers
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 years
  • For Ps group:

plaque psoriasis no previous treatment with biological drugs

- For PsA group: plaque psoriasis with arthropathy no previous treatment with biological drugs but in treatment as per clinical practice or, alternatively, last treatment with drug suspended by a number of days double compared to the half-life of the drug

Exclusion Criteria:

  • Age <18 years
  • Pregnancy
  • Neoplasia in progress or previous (<5 years)
  • Other acute or chronic inflammatory diseases
  • Other rheumatological diseases
  • Metabolic diseases of the primitive bone
  • Recent bone fractures (<6 months)
  • Anxiety, psychosis, depressive disorders
  • Inability to understand the information provided by the recruiter doctor
  • For Ps group:

treatment with biological drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Psoriasis

    Psoriatic arthropathy

    Arm Description

    Outcomes

    Primary Outcome Measures

    Different markers concentration
    Measurement in serum of: MMP-1, MMP-2, MMP-3, MMP-7, MMP-8, MMP-9, MMP-10, MMP-12, MMP-13, TIMP-1, TIMP-2, TIMP-3, TIMP-4, OPG, RANKL, PINP, CTx-I, DKK1, SOST,IL-1beta, IL-4, IL-6, IL-10, IL-17A, IL-17F, IL-21, IL-22, IL-23, IL-25, IL-31, IL-33, INFg, sCD40L, TNFalfa. Correlation with Ps or PsA, and with the severity of the disease

    Secondary Outcome Measures

    Full Information

    First Posted
    December 5, 2017
    Last Updated
    February 27, 2018
    Sponsor
    Istituto Ortopedico Galeazzi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03455166
    Brief Title
    Identification of New Prognostic Markers in Psoriatic Arthritis
    Official Title
    Identification of New Prognostic Markers in Psoriatic Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (Actual)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    September 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Istituto Ortopedico Galeazzi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Identification of possible markers associated with the onset and / or progression of psoriatic arthritis through comparison in patients with psoriasis alone (Ps) and patients with psoriasis with joint involvement (PsA), plasma levels of a panel of cytokines referable to the Th17 pathway , together with serum levels of MMPs, TIMPs and markers of bone remodeling. The primary objective of this study is to verify whether the arthropathy component has an effect on the metabolic activity of osteoblasts. This will be determined through the study of the differences in serum concentrations, between Ps and PsA subjects, of "CTx", the parameter best characterized in terms of analytical variability and intra- and inter-individual variability, in the field of bone metabolism. The secondary objective is the verification of the differences in serum concentrations of the series of parameters specified above, in order to define a complete pattern of variations that can identify the molecular pathways involved in the definition of psoriatic arthropathy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis, Psoriatic Arthritis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Psoriasis
    Arm Type
    Other
    Arm Title
    Psoriatic arthropathy
    Arm Type
    Other
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Serum Markers
    Intervention Description
    Serum Markers
    Primary Outcome Measure Information:
    Title
    Different markers concentration
    Description
    Measurement in serum of: MMP-1, MMP-2, MMP-3, MMP-7, MMP-8, MMP-9, MMP-10, MMP-12, MMP-13, TIMP-1, TIMP-2, TIMP-3, TIMP-4, OPG, RANKL, PINP, CTx-I, DKK1, SOST,IL-1beta, IL-4, IL-6, IL-10, IL-17A, IL-17F, IL-21, IL-22, IL-23, IL-25, IL-31, IL-33, INFg, sCD40L, TNFalfa. Correlation with Ps or PsA, and with the severity of the disease
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥18 years For Ps group: plaque psoriasis no previous treatment with biological drugs - For PsA group: plaque psoriasis with arthropathy no previous treatment with biological drugs but in treatment as per clinical practice or, alternatively, last treatment with drug suspended by a number of days double compared to the half-life of the drug Exclusion Criteria: Age <18 years Pregnancy Neoplasia in progress or previous (<5 years) Other acute or chronic inflammatory diseases Other rheumatological diseases Metabolic diseases of the primitive bone Recent bone fractures (<6 months) Anxiety, psychosis, depressive disorders Inability to understand the information provided by the recruiter doctor For Ps group: treatment with biological drugs

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Identification of New Prognostic Markers in Psoriatic Arthritis

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