PsoriasisNCT04435730
Use of Serum M2BP and MSUS to Predict Arthritis in Psoriatic Patients
An observational study of Psoriasis, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- serum level of Mac 2 binding protein and musculoskeletal ultrasound
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- cutaneous psoriasis Psoriatic arthritis Subclunical psoriatic arthritis
Who cannot join
- any history of liver diseases non-alcoholic fatty liver, viral hepatitis, human immunodeficiency virus (HIV), autoimmune rheumatic disease other than psoriasis and PSA malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Serum Mac-2 Binding Protein and Musculoskeletal Ultrasound to Predict Arthritis in Psoriatic Patients
Aims of the study:
- Measurement of serum level of Mac 2 binding protein among patients with psoriasis, psoriatic arthritis and subclinical psoriatic arthritis compared with healthy individuals.
- Evaluation of MSUS findings in patients with PsA and subclinical psoriatic arthritis
- Evaluation of the role of serum level of Mac 2 binding protein and MSUS in predicting arthritis among psoriatic patients.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- serum level of Mac 2 binding protein, musculoskeletal ultrasound
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 45 patients with cutaneous psoriasis with no musculoskeletal manifestations. Receives: Diagnostic Test: serum level of Mac 2 binding protein; Device: musculoskeletal ultrasound | |
| Group 2 | 45 patients with psoriatic arthritis fulfilling CASPAR criteria of PsA Receives: Diagnostic Test: serum level of Mac 2 binding protein; Device: musculoskeletal ultrasound | |
| Group 3 | 45 patients with subclinical psoriatic arthritis (patients with cutaneous psoriasis and musculoskeletal manifestations but not fulfilling CASPARcriteria of PsA). Receives: Diagnostic Test: serum level of Mac 2 binding protein; Device: musculoskeletal ultrasound | |
| Group 4 | 45 sex and age matched healthy controls Receives: Diagnostic Test: serum level of Mac 2 binding protein; Device: musculoskeletal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start15 Oct 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvia Victor Anis Ross, Assiut University
- Investigators
- Safaa Mahran, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435730
- Sponsor's protocol ID
- M2BP and MSUS in psoriasis
- Status last verified
- Jul 2024
- First submitted
- 15 Jun 2020
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28273019Cretu 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.
PubMed 28586166Cretu 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.
PubMed 25097465
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Serum Mac-2 Binding Protein and Musculoskeletal Ultrasound to Predict Arthritis in Psoriatic Patients
- ClinicalTrials.gov ID
- NCT04435730
- Acronym / sponsor ID
- M2BP and MSUS in psoriasis
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aims of the study:
- Measurement of serum level of Mac 2 binding protein among patients with psoriasis, psoriatic arthritis and subclinical psoriatic arthritis compared with healthy individuals.
- Evaluation of MSUS findings in patients with PsA and subclinical psoriatic arthritis
- Evaluation of the role of serum level of Mac 2 binding protein and MSUS in predicting arthritis among psoriatic patients.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: serum level of Mac 2 binding protein, Device: musculoskeletal ultrasound45 patients with cutaneous psoriasis with no musculoskeletal manifestations. |
| Group 2 | – | Diagnostic Test: serum level of Mac 2 binding protein, Device: musculoskeletal ultrasound45 patients with psoriatic arthritis fulfilling CASPAR criteria of PsA |
| Group 3 | – | Diagnostic Test: serum level of Mac 2 binding protein, Device: musculoskeletal ultrasound45 patients with subclinical psoriatic arthritis (patients with cutaneous psoriasis and musculoskeletal manifestations but not fulfilling CASPARcriteria of PsA). |
| Group 4 | – | Diagnostic Test: serum level of Mac 2 binding protein, Device: musculoskeletal ultrasound45 sex and age matched healthy controls |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- cutaneous psoriasis Psoriatic arthritis Subclunical psoriatic arthritis
Key exclusion criteria (1 listed)
- any history of liver diseases non-alcoholic fatty liver, viral hepatitis, human immunodeficiency virus (HIV), autoimmune rheumatic disease other than psoriasis and PSA malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum level of Mac 2 binding proteinSerum 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. | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
| musculoskeletal ultrasoundMSUS 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. | Device | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 28273019Ritchlin 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.
- Background: PubMed 28586166Cretu 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.
- Background: PubMed 25097465Cretu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safaa Mahran study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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 (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04435730, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.