NCT04435730

Brief Summary

Aims of the study:

  1. 1.Measurement of serum level of Mac 2 binding protein among patients with psoriasis, psoriatic arthritis and subclinical psoriatic arthritis compared with healthy individuals.
  2. 2.Evaluation of MSUS findings in patients with PsA and subclinical psoriatic arthritis
  3. 3.Evaluation of the role of serum level of Mac 2 binding protein and MSUS in predicting arthritis among psoriatic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

2.7 years

First QC Date

June 15, 2020

Last Update Submit

July 29, 2024

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • measurement of serum level of M2BP among psoriasis , psoriatic arthritis and subclinical psoriatic arthritis patients compared with healthy individuals and evaluation of MSUS findings in patients with PsA and subclinical psoriatic arthritis

    detection of the role of serum level of Mac 2 binding protein and MSUS to predict arthritis among psoriatic patients

    baseline

Study Arms (4)

Group 1

45 patients with cutaneous psoriasis with no musculoskeletal manifestations.

Diagnostic Test: serum level of Mac 2 binding proteinDevice: musculoskeletal ultrasound

Group 2

45 patients with psoriatic arthritis fulfilling CASPAR criteria of PsA

Diagnostic Test: serum level of Mac 2 binding proteinDevice: musculoskeletal ultrasound

Group 3

45 patients with subclinical psoriatic arthritis (patients with cutaneous psoriasis and musculoskeletal manifestations but not fulfilling CASPARcriteria of PsA).

Diagnostic Test: serum level of Mac 2 binding proteinDevice: musculoskeletal ultrasound

Group 4

45 sex and age matched healthy controls

Diagnostic Test: serum level of Mac 2 binding proteinDevice: musculoskeletal ultrasound

Interventions

serum level of Mac 2 binding proteinDIAGNOSTIC_TEST

Serum levels of Mac 2 binding protein will be measured for all the study subjects using Enzyme-Linked Immuno sorbent Assay (ELISA). 2 ml of venous blood will be collected from patients and controls under complete aseptic conditions in a plain tube. Sample will be allowed to clot for 15-30 min at room temperature and then centrifuged at 2500 rpm for 10-15 min. Serum will be separated and stored at -20 C or lower till time of assessment.

Group 1Group 2Group 3Group 4
musculoskeletal ultrasoundDEVICE

MSUS examination will be performed for patients of all groups and control group.Gray scale (GSUS) and power Doppler (PDUS) at joints levels and entheses will be performed with the same transducer of My Lab Seven Crystalline esaote machine.

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a case control, cross section study and will include patients with psoriasis, psoriatic arthritis, subclinical psoriatic arthritis and healthy controls aged \> 18 years. . Patients involved in the research will be selected from both Dermatology and Rheumatology and Rehabilitation outpatient clinic and inpatient word in Assuit University Hospital.

You may qualify if:

  • cutaneous psoriasis Psoriatic arthritis Subclunical psoriatic arthritis

You may not qualify if:

  • any history of liver diseases non-alcoholic fatty liver, viral hepatitis, human immunodeficiency virus (HIV), autoimmune rheumatic disease other than psoriasis and PSA malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sylvia

Asyut, Egypt

Location

Related Publications (3)

  • Ritchlin CT, Colbert RA, Gladman DD. Psoriatic Arthritis. N Engl J Med. 2017 Mar 9;376(10):957-970. doi: 10.1056/NEJMra1505557. No abstract available.

    PMID: 28273019BACKGROUND

  • Cretu D, Gao L, Liang K, Soosaipillai A, Diamandis EP, Chandran V. Differentiating Psoriatic Arthritis From Psoriasis Without Psoriatic Arthritis Using Novel Serum Biomarkers. Arthritis Care Res (Hoboken). 2018 Mar;70(3):454-461. doi: 10.1002/acr.23298.

    PMID: 28586166BACKGROUND

  • Cretu D, Prassas I, Saraon P, Batruch I, Gandhi R, Diamandis EP, Chandran V. Identification of psoriatic arthritis mediators in synovial fluid by quantitative mass spectrometry. Clin Proteomics. 2014 Jul 1;11(1):27. doi: 10.1186/1559-0275-11-27. eCollection 2014.

    PMID: 25097465BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Safaa Mahran

    Assiut University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sylvia Victor

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 17, 2020

Study Start

October 15, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations

EG(1)