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
About this trial
This is an interventional other trial for Psoriasis
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
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
NCT ID
NCT03455166
First Posted
December 5, 2017
Last Updated
February 27, 2018
Sponsor
Istituto Ortopedico Galeazzi
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
Learn more about this trial
Identification of New Prognostic Markers in Psoriatic Arthritis
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