Identification of New Prognostic Markers in Psoriatic Arthritis

NCT03455166 | Completed

• 1 other identifier: BIO-ARP
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Study Arms (2)

Psoriasis

OTHER

Diagnostic Test: Serum Markers

Psoriatic arthropathy

OTHER

Diagnostic Test: Serum Markers

Interventions

Serum Markers DIAGNOSTIC_TEST

Serum Markers

Psoriasis; Psoriatic arthropathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: March 6, 2018
• Study Start: May 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: September 1, 2017
• Last Updated: March 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share