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

NCT04074070 | Completed

• 2 other identifiers: APHP1906832018-A02781-54
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

psoriasis; psoriatic arthritis; ultrasound

Outcome Measures

Primary Outcomes (5)

• synovitis

  Number and percentage, N (%) of patients with at least one synovitis.

  through study completion, an average of 1 year

• enthesitis

  N (%) of patients with at least one ultrasound enthesitis.

  through study completion, an average of 1 year

• joint erosion

  N (%) of patients with at least one joint erosion.

  through study completion, an average of 1 year

• osteophyte/ cortical irregularity

  N (%) of patients with at least one osteophyte/ cortical irregularity.

  through study completion, an average of 1 year

• enthesophyte

  N (%) of patients with at least one enthesophyte.

  through study completion, an average of 1 year

Study Arms (3)

Psoriasis with and without musculoskeletal complains

psoriasis with and without musculoskeletal complains

Other: Ultrasound examination

Healthy individuals

Other: Ultrasound examination

Psoriatic arthritis

Other: Ultrasound examination

Interventions

Ultrasound examination OTHER

Ultrasound examination of joints, tendons and entheses.

Healthy individuals; Psoriasis with and without musculoskeletal complains; Psoriatic arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Rheumatology Department, Ambroise Paré Hospital

Boulogne-Billancourt, 92100, France

Location

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Maria-Antonietta D'Agostino, MD, PhD

  Rheumatology Department, Ambroise Paré Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 29, 2019
• Study Start: February 18, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)