Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074070
Recruitment Status : Not yet recruiting
First Posted : August 29, 2019
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.

Condition or disease Intervention/treatment
Psoriasis Other: Ultrasound examination

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Prevalence of Sonographic Abnormalities of Joints and Entheses in Patients With Psoriasis With or Without Musculoskeletal Complains
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis Ultrasound

Group/Cohort Intervention/treatment
Psoriasis with and without musculoskeletal complains
psoriasis with and without musculoskeletal complains
Other: Ultrasound examination
Ultrasound examination of joints, tendons and entheses.

Healthy individuals Other: Ultrasound examination
Ultrasound examination of joints, tendons and entheses.

Psoriatic arthritis Other: Ultrasound examination
Ultrasound examination of joints, tendons and entheses.




Primary Outcome Measures :
  1. synovitis [ Time Frame: through study completion, an average of 1 year ]
    Number and percentage, N (%) of patients with at least one synovitis.

  2. enthesitis [ Time Frame: through study completion, an average of 1 year ]
    N (%) of patients with at least one ultrasound enthesitis.

  3. joint erosion [ Time Frame: through study completion, an average of 1 year ]
    N (%) of patients with at least one joint erosion.

  4. osteophyte/ cortical irregularity [ Time Frame: through study completion, an average of 1 year ]
    N (%) of patients with at least one osteophyte/ cortical irregularity.

  5. enthesophyte [ Time Frame: through study completion, an average of 1 year ]
    N (%) of patients with at least one enthesophyte.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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...).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074070


Contacts
Layout table for location contacts
Contact: Maria-Antonietta D'Agostino, MD, PhD +33 1 49 09 40 45 maria-antonietta.dagostino@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Maria-Antonietta D'Agostino, MD, PhD Rheumatology Department, Ambroise Paré Hospital

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04074070     History of Changes
Other Study ID Numbers: 19MDO-EchoPso
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
psoriasis
psoriatic arthritis
ultrasound
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases