Prevalence of Sonographic Abnormalities of Joints and Entheses in Psoriasis Patients With or Without Musculoskeletal Complains (EchoPso)

March 14, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Prevalence of Sonographic Abnormalities of Joints and Entheses in Patients With Psoriasis With or Without Musculoskeletal Complains

The objectives of this study are:

  • to estimate the prevalence and severity of inflammatory (synovitis, tenosynovitis, enthesitis, dactylitis) and structural (erosions, osteophytes, enthesophytes, cortical irregularities ) ultrasound lesions in psoriasis patients with or without related musculoskeletal symptoms;
  • to compare them to healthy subjects or patients suffering from rheumatoid arthritis and osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne-Billancourt, France, 92100
        • Rheumatology Department, Ambroise Paré Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients consulting the dermatology department of Ambroise Paré hospital for cutaneous psoriasis between September 2019 and December 2020.

Description

Inclusion Criteria:

  • Age ≥ 18 years;
  • Psoriasis diagnosed by a dermatologist;
  • Able to participate in the study;
  • Informed consent signed.

Exclusion Criteria:

- Chronic disease likely to cause musculoskeletal symptoms (connective tissue diseases, inflammatory bowel diseases, overload disorders, crystal related arthritis, septic arthritis...).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy individuals
Other: Ultrasound examination
Ultrasound examination of joints, tendons and entheses.
Psoriatic arthritis
Other: Ultrasound examination
Ultrasound examination of joints, tendons and entheses.
Psoriasis with and without musculoskeletal complains
psoriasis with and without musculoskeletal complains
Other: Ultrasound examination
Ultrasound examination of joints, tendons and entheses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
synovitis
Time Frame: through study completion, an average of 1 year
Number and percentage, N (%) of patients with at least one synovitis.
through study completion, an average of 1 year
enthesitis
Time Frame: through study completion, an average of 1 year
N (%) of patients with at least one ultrasound enthesitis.
through study completion, an average of 1 year
joint erosion
Time Frame: through study completion, an average of 1 year
N (%) of patients with at least one joint erosion.
through study completion, an average of 1 year
osteophyte/ cortical irregularity
Time Frame: through study completion, an average of 1 year
N (%) of patients with at least one osteophyte/ cortical irregularity.
through study completion, an average of 1 year
enthesophyte
Time Frame: through study completion, an average of 1 year
N (%) of patients with at least one enthesophyte.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Maria-Antonietta D'Agostino, MD, PhD, Rheumatology Department, Ambroise Paré Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP190683
  • 2018-A02781-54 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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