Psoriatic ArthritisNCT05637905
Monocyte Chemoattractant Protein-1 in Psoriatic Arthritis Patients
An observational study of Psoriatic Arthritis, run by Assiut University.
Trial summary
1. Evaluate serum levels of (MCP-1) in PsA with or without cardiovascular affaction . 2. Detect subclinical cardiovascular affaction in patients with PsA for early diagnosis and management . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriatic Arthritis
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jun 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: psoriatic arthritis patients with or without clinically cardiovascular affaction
Who may be able to join
- PsA patients (age ≥ 18years) who fulfilled the CASPAR classification criteria[15]for psoriatic arthritis
Who cannot join
- PsA patients with
- infection.
- bone marrow disorders.
- other autoimmune diseases.
- diabetes.
- hypertention .
Show all 9Show fewer
- hyperlipidemia.
- liver diseases.
- renal diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Predictive Value of Monocyte Chemoattractant Protein -1 in the Development of Cardiovacular Events in Psoriatic Arthritis Patients
- Evaluate serum levels of (MCP-1) in PsA with or without cardiovascular affaction .
- Detect subclinical cardiovascular affaction in patients with PsA for early diagnosis and management .
Read the detailed description
Psoriatic arthritis (PSA) is an autoimmune disease arising from the interply between proinflamatory cytokines
[1]and external stimuli in genetically predisposed individuals.[2]
- The disease is chronic and affects the peripheral joints and may include axial skeleton with or without extrarticular manifestations.[3]
- Abnormal activation of the innate and adaptive immune systems contributes to chronic disease processes in both psoriasis and PSA .[4] The skin and the joints exhibit a prominent lymphocytic infiltrate consisting of activated CD4+ and CD8+ T cells as well as an increase in neutrophil infiltration[5].
Patients with PsA have a higher risk of developing a cardiovascular(CV) events than the general population. This could be attributed to the higher prevalence of traditional cardiovascular risk factors and to the disease characteristics such as systemic inflammation. [6] These patients may show asymptomatic cardiomyopathy even in the absence of traditional risk factors [7].Cardiac dysfunction is associated with a poor prognosis, increased mortality, and affact socioecenomic function of patients therefore, the diagnosis of the cardiac dysfunction in the asymptomatic phase of the disease [8] is important for the timely introduction of therapy [9].Monocyte chemotactic protien1(MCP-1) is a member of chemotactic chemokines(CC) which are secreted by immune effector cells and dysfunctional endothelium [10].
- The pivotal function of MCP-1 is to attract monocyte in the arterial wall through increased expression of adhesion molecules on their surface that interacts with endothelium[11].
- MCP-1 induce maturation of monocyte in the arterial wall ,which then become specialized macrophage in early atheroma and produce tissue factors supporting coagulation and proinflammatory cytokines such as IL-1 and IL-6. It affects the functions of the surrounding immune effector cells in locally thickened intima.[12]
- During active disease in psoriatic skin lesions and synovial tissue, activated monocytes represent the major source of proinflammatory mediators, including the chemokine MCP-1 [13]. MCP-1 is thought to be involved in the pathogenesis of oedema and bone erosion in patients with PsA [14].
- Conditions
- Psoriatic Arthritis
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| psoriatic arthritis patients group | Not described | |
| health control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCP-1
:Evaluate serum levels of monocyte chemoattractant protein-1(MCP-1) in relation to echocardiographic changes in patient with psoriatic arthritis.
Measured: two month
Secondary outcomes (1)
Echocardiography
b.Detect subclinical cardiovascular affaction in patient with psoriatic arthritis.
Measured: two month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies 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
- Other
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Anas Mostafa Mohamed, Assiut University
- Investigators
- Eman Abass, doctor, Study director, Assiut UniversityMohamed Raouf, doctor, Study director, Assiut UniversityEsraa Ahmed, doctor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637905
- Sponsor's protocol ID
- MCP-1
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Monocyte Chemoattractant Protein -1 in the Development of Cardiovacular Events in Psoriatic Arthritis Patients
- ClinicalTrials.gov ID
- NCT05637905
- Acronym / sponsor ID
- MCP-1
- Conditions
- Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 6 Dec 2022 (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.
- Evaluate serum levels of (MCP-1) in PsA with or without cardiovascular affaction .
- Detect subclinical cardiovascular affaction in patients with PsA for early diagnosis and management .
Detailed description
Psoriatic arthritis (PSA) is an autoimmune disease arising from the interply between proinflamatory cytokines
[1]and external stimuli in genetically predisposed individuals.[2]
- The disease is chronic and affects the peripheral joints and may include axial skeleton with or without extrarticular manifestations.[3]
- Abnormal activation of the innate and adaptive immune systems contributes to chronic disease processes in both psoriasis and PSA .[4] The skin and the joints exhibit a prominent lymphocytic infiltrate consisting of activated CD4+ and CD8+ T cells as well as an increase in neutrophil infiltration[5].
Patients with PsA have a higher risk of developing a cardiovascular(CV) events than the general population. This could be attributed to the higher prevalence of traditional cardiovascular risk factors and to the disease characteristics such as systemic inflammation. [6] These patients may show asymptomatic cardiomyopathy even in the absence of traditional risk factors [7].Cardiac dysfunction is associated with a poor prognosis, increased mortality, and affact socioecenomic function of patients therefore, the diagnosis of the cardiac dysfunction in the asymptomatic phase of the disease [8] is important for the timely introduction of therapy [9].Monocyte chemotactic protien1(MCP-1) is a member of chemotactic chemokines(CC) which are secreted by immune effector cells and dysfunctional endothelium [10].
- The pivotal function of MCP-1 is to attract monocyte in the arterial wall through increased expression of adhesion molecules on their surface that interacts with endothelium[11].
- MCP-1 induce maturation of monocyte in the arterial wall ,which then become specialized macrophage in early atheroma and produce tissue factors supporting coagulation and proinflammatory cytokines such as IL-1 and IL-6. It affects the functions of the surrounding immune effector cells in locally thickened intima.[12]
- During active disease in psoriatic skin lesions and synovial tissue, activated monocytes represent the major source of proinflammatory mediators, including the chemokine MCP-1 [13]. MCP-1 is thought to be involved in the pathogenesis of oedema and bone erosion in patients with PsA [14].
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psoriatic arthritis patients group | – | – |
| health control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- psoriatic arthritis patients with or without clinically cardiovascular affaction
Key inclusion criteria (1 listed)
- PsA patients (age ≥ 18years) who fulfilled the CASPAR classification criteria[15]for psoriatic arthritis
Key exclusion criteria (9 listed)
- PsA patients with
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MCP-1
Time frame: two month
:Evaluate serum levels of monocyte chemoattractant protein-1(MCP-1) in relation to echocardiographic changes in patient with psoriatic arthritis.
1 secondary outcome
Echocardiography
Time frame: two month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- 1.V.Chandran,F.Abji,A.V. Perruccio et al.,"Serum-basedsoluble markers difffferentiate psoriatic arthritis from osteoarthritis," Annals of the Rheumatic Diseases,vol.78, no.6, pp.796-801,2019.Link provided by the sponsor.
- A. L. Carvalho and C. M. Hedrich, "The molecular pathophysiology of psoriatic arthritis-the complex interplay between genetic predisposition, epigenetics factors, and the microbiome," Frontiers in Molecular Biosciences, vol. 8, p. 662047, 2021.Link provided by the sponsor.
- A. B. Gottlieb and J. F. Merola, "Axial psoriatic arthritis: an update for dermatologists," Journal of the American Academy of Dermatology, vol. 84, no. 1, pp. 92-101, 2021Link provided by the sponsor.
- Lories RJ, de Vlam K. Is psoriatic arthritis a result of abnormalities in acquired or innate immunity? Curr Rheumatol Rep 2012; 14: 375-382.Link provided by the sponsor.
- .Lowes MA, Kikuchi T, Fuentes-Duculan J, Cardinale I, Zaba LC, Haider AS, et al. Psoriasis vulgaris lesions contain discrete populations of Th1 and Th17 T cells. J Invest Dermatol 2008; 128: 1207-12Link provided by the sponsor.
- Risk Reclassification According to Cardiovascular Six Traditional Cardiovascular Risk Algorithms and a Carotid Ultrasound in Psoriatic Arthritis PatientsLink provided by the sponsor.
Related trials for Psoriatic Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis
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.
Eman Abass, doctor study director
Assiut University
Mohamed Raouf, doctor study director
Assiut University
Esraa Ahmed, doctor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Assiut University.
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 9 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: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Anas, Master (01066633924, amiraanas60@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCP-1 (time frame: two month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2022.