Identification of New Prognostic Markers in Psoriatic Arthritis

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

Status: Completed

Conditions: Psoriasis; Psoriatic Arthritis

Treatments: Diagnostic Test: Serum Markers

Study type: Interventional

Funder types: Other

Identifiers

NCT03455166

BIO-ARP

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Psoriasis

Other group

Treatment:

Diagnostic Test: Serum Markers

Psoriatic arthropathy

Other group

Treatment:

Diagnostic Test: Serum Markers