Use of Serum M2BP and MSUS to Predict Arthritis in Psoriatic Patients

Psoriasis Clinical Trial

Official title:

Use of Serum Mac-2 Binding Protein and Musculoskeletal Ultrasound to Predict Arthritis in Psoriatic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04435730
• Other study ID #: M2BP and MSUS in psoriasis
• Status: Not yet recruiting
• Start date: October 2020
• Est. completion date: December 2022

Study information

• Verified date: June 2020
• Source: Assiut University
• Contact: Sylvia Victor
• Phone: 01220549500
• Email: sylvia_victor[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aims of the study:

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. Evaluation of MSUS findings in patients with PsA and subclinical psoriatic arthritis

3. Evaluation of the role of serum level of Mac 2 binding protein and MSUS in predicting arthritis among psoriatic patients.

Description:

Psoriasis is a quite common chronic, inflammatory immune-mediated skin disease affecting about 2% of the population . Also psoriasis is a strong risk factor for the development of several comorbidities of which the most common is psoriatic arthritis (PsA).

The presence of cutaneous psoriasis indicates a high risk for developing PsA. Studies conducted in dermatology clinics have shown a high prevalence of undiagnosed PsA in psoriasis patients , therefore identifying soluble biomarkers for PsA in psoriasis patients may help in early diagnosis, and thereby prevent disability and improve quality of life .

Mac 2 binding protein [M2BP] is thought to be a marker of synovial cell activation and joint destruction .M2BP may be involved in the pathogenesis of PsA .

Recently, with the introduction of new medications and wider use of musculoskeletal ultrasound (US) imaging in clinical practice, the possibility of earlier US diagnosis in patients with psoriasis in the pre-clinical phase of PsA has been examined.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

cutaneous psoriasis Psoriatic arthritis Subclunical psoriatic arthritis

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Arthritis
• Psoriasis

Intervention

Diagnostic Test:
• serum level of Mac 2 binding protein
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.

Device:
• musculoskeletal ultrasound
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View Citation

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. — View Citation

Ritchlin CT, Colbert RA, Gladman DD. Psoriatic Arthritis. N Engl J Med. 2017 Mar 9;376(10):957-970. doi: 10.1056/NEJMra1505557. Review. Erratum in: N Engl J Med. 2017 May 25;376(21):2097. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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