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Trial record 26 of 52 for:    TIMP2

Identification of New Prognostic Markers in Psoriatic Arthritis

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ClinicalTrials.gov Identifier: NCT03455166
Recruitment Status : Completed
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

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.


Condition or disease Intervention/treatment Phase
Psoriasis Psoriatic Arthritis Diagnostic Test: Serum Markers Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Identification of New Prognostic Markers in Psoriatic Arthritis
Actual Study Start Date : May 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : September 2017


Arm Intervention/treatment
Psoriasis Diagnostic Test: Serum Markers
Serum Markers

Psoriatic arthropathy Diagnostic Test: Serum Markers
Serum Markers




Primary Outcome Measures :
  1. Different markers concentration [ Time Frame: 1 year ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


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Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03455166     History of Changes
Other Study ID Numbers: BIO-ARP
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arthritis
Psoriasis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases