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

July 29, 2024 updated by: Sylvia Victor Anis Ross, Assiut University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Sylvia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
45 patients with cutaneous psoriasis with no musculoskeletal manifestations.
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.
Group 2
45 patients with psoriatic arthritis fulfilling CASPAR criteria of PsA
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.
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 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.
Group 4
45 sex and age matched healthy controls
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: baseline
detection of the role of serum level of Mac 2 binding protein and MSUS to predict arthritis among psoriatic patients
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Safaa Mahran, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2BP and MSUS in psoriasis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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