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Identification of New Prognostic Markers in Psoriatic Arthritis

Identification of New Prognostic Markers in Psoriatic Arthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03455166
Enrollment
100
Registered
2018-03-06
Start date
2015-05-31
Completion date
2017-09-30
Last updated
2018-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis, Psoriatic Arthritis

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.

Interventions

DIAGNOSTIC_TESTSerum Markers

Serum Markers

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Different markers concentration1 yearMeasurement 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026