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CompletedNCT03455166Updated Mar 6, 2018

Identification of New Prognostic Markers in Psoriatic Arthritis

An interventional study of Serum Markers in Psoriasis and Psoriatic Arthritis, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-06.

Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis
  • Psoriatic Arthritis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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

04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Other
    Psoriasis

    Diagnostic Test: Serum Markers

  • Other
    Psoriatic arthropathy

    Diagnostic Test: Serum Markers

Interventions

  • Diagnostic testSerum Markers

    Serum Markers

05

What researchers measure

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

    Time frame: 1 year

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03455166
Lead sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible party
Sponsor
First posted
Mar 6, 2018
Start date
May 2015
Primary completion
Apr 2016
Completion
Sep 2017
Last update
Mar 6, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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