<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04435730</url>
  </required_header>
  <id_info>
    <org_study_id>M2BP and MSUS in psoriasis</org_study_id>
    <nct_id>NCT04435730</nct_id>
  </id_info>
  <brief_title>Use of Serum M2BP and MSUS to Predict Arthritis in Psoriatic Patients</brief_title>
  <official_title>Use of Serum Mac-2 Binding Protein and Musculoskeletal Ultrasound to Predict Arthritis in Psoriatic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aims of the study:&#xD;
&#xD;
        1. Measurement of serum level of Mac 2 binding protein among patients with psoriasis,&#xD;
           psoriatic arthritis and subclinical psoriatic arthritis compared with healthy&#xD;
           individuals.&#xD;
&#xD;
        2. Evaluation of MSUS findings in patients with PsA and subclinical psoriatic arthritis&#xD;
&#xD;
        3. Evaluation of the role of serum level of Mac 2 binding protein and MSUS in predicting&#xD;
           arthritis among psoriatic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Psoriasis is a quite common chronic, inflammatory immune-mediated skin disease affecting&#xD;
      about 2% of the population . Also psoriasis is a strong risk factor for the development of&#xD;
      several comorbidities of which the most common is psoriatic arthritis (PsA).&#xD;
&#xD;
      The presence of cutaneous psoriasis indicates a high risk for developing PsA. Studies&#xD;
      conducted in dermatology clinics have shown a high prevalence of undiagnosed PsA in psoriasis&#xD;
      patients , therefore identifying soluble biomarkers for PsA in psoriasis patients may help in&#xD;
      early diagnosis, and thereby prevent disability and improve quality of life .&#xD;
&#xD;
      Mac 2 binding protein [M2BP] is thought to be a marker of synovial cell activation and joint&#xD;
      destruction .M2BP may be involved in the pathogenesis of PsA .&#xD;
&#xD;
      Recently, with the introduction of new medications and wider use of musculoskeletal&#xD;
      ultrasound (US) imaging in clinical practice, the possibility of earlier US diagnosis in&#xD;
      patients with psoriasis in the pre-clinical phase of PsA has been examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">October 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>baseline</time_frame>
    <description>detection of the role of serum level of Mac 2 binding protein and MSUS to predict arthritis among psoriatic patients</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>45 patients with cutaneous psoriasis with no musculoskeletal manifestations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>45 patients with psoriatic arthritis fulfilling CASPAR criteria of PsA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>45 patients with subclinical psoriatic arthritis (patients with cutaneous psoriasis and musculoskeletal manifestations but not fulfilling CASPARcriteria of PsA).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4</arm_group_label>
    <description>45 sex and age matched healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>serum level of Mac 2 binding protein</intervention_name>
    <description>Serum levels of Mac 2 binding protein will be measured for all the study subjects using Enzyme-Linked Immuno sorbent Assay (ELISA).&#xD;
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.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>musculoskeletal ultrasound</intervention_name>
    <description>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.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_label>Group 4</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This is a case control, cross section study and will include patients with psoriasis,&#xD;
        psoriatic arthritis, subclinical psoriatic arthritis and healthy controls aged &gt; 18 years.&#xD;
        .&#xD;
&#xD;
        Patients involved in the research will be selected from both Dermatology and Rheumatology&#xD;
        and Rehabilitation outpatient clinic and inpatient word in Assuit University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        cutaneous psoriasis Psoriatic arthritis Subclunical psoriatic arthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        any history of liver diseases non-alcoholic fatty liver, viral hepatitis, human&#xD;
        immunodeficiency virus (HIV), autoimmune rheumatic disease other than psoriasis and PSA&#xD;
        malignancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Safaa Mahran</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sylvia Victor</last_name>
    <phone>01220549500</phone>
    <email>sylvia_victor@outlook.com</email>
  </overall_contact>
  <reference>
    <citation>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. Erratum In: N Engl J Med. 2017 May 25;376(21):2097.</citation>
    <PMID>28273019</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28586166</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25097465</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Sylvia Victor Anis Ross</investigator_full_name>
    <investigator_title>Sylvia Victor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04435730
org study id: M2BP and MSUS in psoriasis
nct id: NCT04435730
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: 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
description: detection of the role of serum level of Mac 2 binding protein and MSUS to predict arthritis among psoriatic patients
arm group label: Group 1
description: 45 patients with cutaneous psoriasis with no musculoskeletal manifestations.
arm group label: Group 2
description: 45 patients with psoriatic arthritis fulfilling CASPAR criteria of PsA
arm group label: Group 3
description: 45 patients with subclinical psoriatic arthritis (patients with cutaneous psoriasis and musculoskeletal manifestations but not fulfilling CASPARcriteria of PsA).
arm group label: Group 4
description: 45 sex and age matched healthy controls
intervention type: Diagnostic Test
intervention name: serum level of Mac 2 binding protein
description: 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.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
intervention type: Device
intervention name: musculoskeletal ultrasound
description: 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.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
arm group label: Group 4
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Safaa Mahran
role: Study Chair
affiliation: Assiut University
last name: Sylvia Victor
phone: 01220549500
email: sylvia_victor@outlook.com
citation: 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. Erratum In: N Engl J Med. 2017 May 25;376(21):2097.
PMID: 28273019
citation: 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: 28586166
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.
PMID: 25097465
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Sylvia Victor Anis Ross
investigator title: Sylvia Victor
mesh term: Arthritis
mesh term: Psoriasis