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

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ClinicalTrials.gov Identifier: NCT04074070
Recruitment Status : Not yet recruiting
First Posted : August 29, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date August 19, 2019
First Posted Date August 29, 2019
Last Update Posted Date September 3, 2019
Estimated Study Start Date September 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 29, 2019)
  • synovitis [ Time Frame: through study completion, an average of 1 year ]
    Number and percentage, N (%) of patients with at least one synovitis.
  • enthesitis [ Time Frame: through study completion, an average of 1 year ]
    N (%) of patients with at least one ultrasound enthesitis.
  • joint erosion [ Time Frame: through study completion, an average of 1 year ]
    N (%) of patients with at least one joint erosion.
  • osteophyte/ cortical irregularity [ Time Frame: through study completion, an average of 1 year ]
    N (%) of patients with at least one osteophyte/ cortical irregularity.
  • enthesophyte [ Time Frame: through study completion, an average of 1 year ]
    N (%) of patients with at least one enthesophyte.
Original Primary Outcome Measures
 (submitted: August 28, 2019)
  • Prevalence of inflammatory: synovitis [ Time Frame: through study completion, an average of 1 year ]
    Number and percentage, N (%) of patients with at least one synovitis.
  • Prevalence of inflammatory: enthesitis [ Time Frame: through study completion, an average of 1 year ]
    N (%) of patients with at least one ultrasound enthesitis.
  • Prevalence of inflammatory: joint erosion [ Time Frame: through study completion, an average of 1 year ]
    N (%) of patients with at least one joint erosion.
  • Prevalence of inflammatory: osteophyte/ cortical irregularity [ Time Frame: through study completion, an average of 1 year ]
    N (%) of patients with at least one osteophyte/ cortical irregularity.
  • Prevalence of inflammatory: enthesophyte [ Time Frame: through study completion, an average of 1 year ]
    N (%) of patients with at least one enthesophyte.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Sonographic Abnormalities of Joints and Entheses in Psoriasis Patients With or Without Musculoskeletal Complains
Official Title Prevalence of Sonographic Abnormalities of Joints and Entheses in Patients With Psoriasis With or Without Musculoskeletal Complains
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Psoriasis
Intervention Other: Ultrasound examination
Ultrasound examination of joints, tendons and entheses.
Study Groups/Cohorts
  • Psoriasis with and without musculoskeletal complains
    psoriasis with and without musculoskeletal complains
    Intervention: Other: Ultrasound examination
  • Healthy individuals
    Intervention: Other: Ultrasound examination
  • Psoriatic arthritis
    Intervention: Other: Ultrasound examination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 28, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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...).

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Maria-Antonietta D'Agostino, MD, PhD +33 1 49 09 40 45 maria-antonietta.dagostino@aphp.fr
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04074070
Other Study ID Numbers 19MDO-EchoPso
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Maria-Antonietta D'Agostino, MD, PhD Rheumatology Department, Ambroise Paré Hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date August 2019