Disparity Between Ultrasound- and Clinical Findings in Psoriatic Arthritis in Remission

NCT03396679 | Completed

• 1 other identifier: 9855
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of the proportion of Psoriatic arthritis patients in ultrasound remission (i.e. no power Doppler synovitis, tenosynovitis, dactylitis, enthesitis, PD=0) depending on whether patient and physician's global assessment of disease activity are in agreement or in disagreement.

Conditions

PsA Patients Fulfilling CASPAR Criteria in Remission

Keywords

Psoriatic arthritis; remission; ultrasound

Outcome Measures

Primary Outcomes (1)

• Evaluation of Psoriasic arthritis remission

  In PsA patients deemed to be in remission according to their assessing consultant rheumatologist (i.e. low physician's global assessment of disease activity), to compare the proportion of patients with persistant ultrasound findings of inflammation by Ultrasound examination (i.e. at least one power Doppler synovitis, tenosynovitis, dactylitis, enthesitis, = PD\>0) depending on whether patient and physician's global assessments of disease activity are in agreement or in disagreement.

  6 months

Secondary Outcomes (14)

• Comparison of proportion of patients in clinical remission to proportion of patients in ultrasound remission (or minimal ultrasound disease activity)

  6 months

• Comparison of clinical remission and ultrasound remission according to DAPSA criteria

  6 months

• Correlation between different composite clinical scores and ultrasound findings

  6 months

• Correlation between different composite clinical scores and ultrasound findings

  6 months

• Correlation between different composite clinical scores and ultrasound findings

  6 months

Study Arms (2)

CASPAR criteria agreement

PsA patients fulfilling CASPAR criteria in remission as determined by physician with patient and physician's global assessment of disease activity in agreement compare to Ultrasound examination

Other: Ultrasound examination

CASPAR criteria disagreement

PsA patients fulfilling CASPAR criteria in remission as determined by physician with patient and physician's global assessment of disease activity in disagreement compare to Ultrasound examination

Other: Ultrasound examination

Interventions

Ultrasound examination OTHER

Evaluation of the Psoriatic Arthritis remission according to patient and physician's global assessment of disease activity are in agreement (CASPAR criteria agreement) or in disagreement (CASPAR criteria disagreement)

CASPAR criteria agreement; CASPAR criteria disagreement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PsA patients fulfilling CASPAR criteria in remission as determined by physician, with stable treatment

You may qualify if:

• \- PsA patients fulfilling CASPAR criteria in remission as determined by physician, with stable treatment

You may not qualify if:

• \- patient simultaneously included in another study with blinded treatment; Steinbrocker class IV patients

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Lapeyronie

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Gaël MOUTERDE, MD

  Montpellier Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: January 11, 2018
• Study Start: November 2, 2017
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)