PsoriasisNCT03374527
Recirculating Memory T Cells in the Pathogenesis of Psoriatic Arthritis and Cutaneous Psoriasis
An observational study of Psoriasis and Psoriatic Arthritis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The aim of the study is to investigate the link between pro-inflammatory T cells responses arising in the skin in patients with cutaneous psoriasis and those present in the joints of patients developing psoriatic arthritis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Psoriatic Arthritis
- What is being tested?
- blood sample collection and Synovial Fluid collection
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- 16 Oct 2014to 13 Jun 2018
- How long will I take part?
- 1 Day
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort
Who may be able to join
- Patients with a diagnosis of cutaneous psoriasis without clinical signs of PsA,
- Patients with a diagnosis of PsA
- Healthy subjects with a negative family and personal anamnesis for psoriasis.
- Absence of acute and chronic systemic or cutaneous infections during sample collections.
Who cannot join
- Treatment with cyclosporin A, methotrexate, systemic corticosteroids or any other immunosuppressant agent within 3 weeks before the blood samples collections.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the link between pro-inflammatory T cells responses arising in the skin in patients with cutaneous psoriasis and those present in the joints of patients developing psoriatic arthritis.
The study is based on the hypothesis that a fraction of T cells with memory phenotype can recirculate from the skin and relocalize at extracutaneous sites including enthesis or synovial tissue thus propagating the pro-inflammatory cycle. This could represent a pathogenic mechanism in the development of PsA.
Read more
The main aim of the study is to define the phenotypic and functional differences of circulating T cells in patients cutaneous psoriasis, patients with psoriatic arthritis and in control group of healthy subject.
To this end the investigators analyze the expression of cell surface markers of central memory (TCM), effector memory (TEM) and effector (Teff) cells, within this subsets the investigators evaluate the expression of chemokine receptors as well as skin and tissue homing molecules. There will be also an evaluation of the T cell polarization towards Th1/Tc1 or Th17/Tc17 phenotype by evaluating the cytokine expression profile.
In selected patients with PsA the researchers analyze in parallel the phenotype and the cytokine profile of T cell subpopulations in peripheral blood and in synovial fluid, The results of this study could possibly allow to define distinctive features of circulating T cells in patients with PsA and to understand the link between circulating and synovial fluid T cells in patients with PsA.
- Conditions
- Psoriasis, Psoriatic Arthritis
- Being tested
- blood sample collection, Synovial Fluid collection
- Keywords
- T-cells, circulation, synovial fluid, psoriasis, psoriatic arthritis
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample collectionOther
Blood samples are collected from patients with psoriasis vulgaris and patients with psoriatic arthritis following the routine procedure. Blood samples will also be collected from healthy control subjects.
Synovial Fluid collectionProcedure or surgery
Synovial fluid is collected when prescribed in patients with psoriatic arthritis
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis | Patients with psoriasis vulgarism without clinical signs of PsA Receives: Other: blood sample collection | |
| Psoriatic Arthritis (PsA) | Patients with a diagnosis of psoriatic arthritis and cutaneous psoriasis Receives: Other: blood sample collection; Procedure: Synovial Fluid collection | |
| Control group | Healthy subjects Receives: Other: blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the percentage of different subsets of memory T cells in the circulation of patients with psoriasis, patients with psoriatic arthritis and a control group of healthy subject.
Central memory, Effector memory and Effector cell markers are evaluated in circulating CD4 and CD8 T cells. Within these subsets the expression of chemokine receptors is also evaluated and we define the cytokine secretion profile for each subset.
Measured: At time of blood collection
Secondary outcomes (2)
Correlation between the circulating percentage of individual subsets of CD4 and CD8 T cells and the clinical disease parameters: Psoriasis Area and Severity Index (PASI) Score and serum level of C reactive protein (CRP)
For each subsets it is calculated the correlation between the percentage in the circulation and either the Psoriasis Area and Severity Index (PASI) score or the serum level of C reactive protein
Measured: At time of blood collection
Parallel analysis of the phenotype of CD4 and CD8 T cells in the circulation and in synovial fluid of patients with psoriatic arthritis.
Phenotype and functional analysis of T Cells
Measured: At time of blood and synovial fluid collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start16 Oct 2014
- Primary completion30 Jan 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Reali, Dr., Principal investigator, I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374527
- Sponsor's protocol ID
- T-ART
- Status last verified
- Aug 2019
- First submitted
- 11 Dec 2017
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Diani M, Galasso M, Cozzi C, Sgambelluri F, Altomare A, Cigni C, Frigerio E, Drago L, Volinia S, Granucci F, Altomare G, Reali E. Blood to skin recirculation of CD4+ memory T cells associates with cutaneous and systemic manifestations of psoriatic disease. Clin Immunol. 2017 Jul;180:84-94. doi: 10.1016/j.clim.2017.04.001. Epub 2017 Apr 6.
PubMed 28392462Sgambelluri F, Diani M, Altomare A, Frigerio E, Drago L, Granucci F, Banfi G, Altomare G, Reali E. A role for CCR5(+)CD4 T cells in cutaneous psoriasis and for CD103(+) CCR4(+) CD8 Teff cells in the associated systemic inflammation. J Autoimmun. 2016 Jun;70:80-90. doi: 10.1016/j.jaut.2016.03.019. Epub 2016 Apr 8.
PubMed 27068801Casciano F, Severi P, Marongiu L, Caproni A, Terranova C, Spitilli A, Ferrari D, Ruzza C, Marconi P, Rizzo P, Granucci F, Secchiero P, Reali E. Highly differentiated T cells link systemic and vascular inflammation in a mouse model of recurrent psoriasis. Front Immunol. 2025 Jun 17;16:1574455. doi: 10.3389/fimmu.2025.1574455. eCollection 2025.
PubMed 40599782Casciano F, Diani M, Altomare A, Granucci F, Secchiero P, Banfi G, Reali E. CCR4+ Skin-Tropic Phenotype as a Feature of Central Memory CD8+ T Cells in Healthy Subjects and Psoriasis Patients. Front Immunol. 2020 Apr 3;11:529. doi: 10.3389/fimmu.2020.00529. eCollection 2020.
PubMed 32318062
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recirculating Memory T Cells in the Pathogenesis of Psoriatic Arthritis and Cutaneous Psoriasis
- ClinicalTrials.gov ID
- NCT03374527
- Acronym / sponsor ID
- T-ART
- Conditions
- Psoriasis, Psoriatic Arthritis
- Keywords
- T-cells, circulation, synovial fluid, psoriasis, psoriatic arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 16 Oct 2014 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 15 Dec 2017 (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.
The aim of the study is to investigate the link between pro-inflammatory T cells responses arising in the skin in patients with cutaneous psoriasis and those present in the joints of patients developing psoriatic arthritis.
The study is based on the hypothesis that a fraction of T cells with memory phenotype can recirculate from the skin and relocalize at extracutaneous sites including enthesis or synovial tissue thus propagating the pro-inflammatory cycle. This could represent a pathogenic mechanism in the development of PsA.
The main aim of the study is to define the phenotypic and functional differences of circulating T cells in patients cutaneous psoriasis, patients with psoriatic arthritis and in control group of healthy subject.
To this end the investigators analyze the expression of cell surface markers of central memory (TCM), effector memory (TEM) and effector (Teff) cells, within this subsets the investigators evaluate the expression of chemokine receptors as well as skin and tissue homing molecules. There will be also an evaluation of the T cell polarization towards Th1/Tc1 or Th17/Tc17 phenotype by evaluating the cytokine expression profile.
In selected patients with PsA the researchers analyze in parallel the phenotype and the cytokine profile of T cell subpopulations in peripheral blood and in synovial fluid, The results of this study could possibly allow to define distinctive features of circulating T cells in patients with PsA and to understand the link between circulating and synovial fluid T cells in patients with PsA.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psoriasis | – | Other: blood sample collectionPatients with psoriasis vulgarism without clinical signs of PsA |
| Psoriatic Arthritis (PsA) | – | Other: blood sample collection, Procedure: Synovial Fluid collectionPatients with a diagnosis of psoriatic arthritis and cutaneous psoriasis |
| Control group | – | Other: blood sample collectionHealthy subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort
Key inclusion criteria (4 listed)
- Patients with a diagnosis of cutaneous psoriasis without clinical signs of PsA,
- Patients with a diagnosis of PsA
- Healthy subjects with a negative family and personal anamnesis for psoriasis.
- Absence of acute and chronic systemic or cutaneous infections during sample collections.
Key exclusion criteria (1 listed)
- Treatment with cyclosporin A, methotrexate, systemic corticosteroids or any other immunosuppressant agent within 3 weeks before the blood samples collections.
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 |
|---|---|---|
| blood sample collectionBlood samples are collected from patients with psoriasis vulgaris and patients with psoriatic arthritis following the routine procedure. Blood samples will also be collected from healthy control subjects. | Other | Control group, Psoriasis, Psoriatic Arthritis (PsA) |
| Synovial Fluid collectionSynovial fluid is collected when prescribed in patients with psoriatic arthritis | Procedure or surgery | Psoriatic Arthritis (PsA) |
Primary outcome
Evaluation of the percentage of different subsets of memory T cells in the circulation of patients with psoriasis, patients with psoriatic arthritis and a control group of healthy subject.
Time frame: At time of blood collection
Central memory, Effector memory and Effector cell markers are evaluated in circulating CD4 and CD8 T cells. Within these subsets the expression of chemokine receptors is also evaluated and we define the cytokine secretion profile for each subset.
2 secondary outcomes
Correlation between the circulating percentage of individual subsets of CD4 and CD8 T cells and the clinical disease parameters: Psoriasis Area and Severity Index (PASI) Score and serum level of C reactive protein (CRP)
Time frame: At time of blood collection
Parallel analysis of the phenotype of CD4 and CD8 T cells in the circulation and in synovial fluid of patients with psoriatic arthritis.
Time frame: At time of blood and synovial fluid collection
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 9 Sep 2019.
- Results publication: PubMed 28392462Diani M, Galasso M, Cozzi C, Sgambelluri F, Altomare A, Cigni C, Frigerio E, Drago L, Volinia S, Granucci F, Altomare G, Reali E. Blood to skin recirculation of CD4+ memory T cells associates with cutaneous and systemic manifestations of psoriatic disease. Clin Immunol. 2017 Jul;180:84-94. doi: 10.1016/j.clim.2017.04.001. Epub 2017 Apr 6.
- Results publication: PubMed 27068801Sgambelluri F, Diani M, Altomare A, Frigerio E, Drago L, Granucci F, Banfi G, Altomare G, Reali E. A role for CCR5(+)CD4 T cells in cutaneous psoriasis and for CD103(+) CCR4(+) CD8 Teff cells in the associated systemic inflammation. J Autoimmun. 2016 Jun;70:80-90. doi: 10.1016/j.jaut.2016.03.019. Epub 2016 Apr 8.
- Derived from this study: PubMed 40599782Casciano F, Severi P, Marongiu L, Caproni A, Terranova C, Spitilli A, Ferrari D, Ruzza C, Marconi P, Rizzo P, Granucci F, Secchiero P, Reali E. Highly differentiated T cells link systemic and vascular inflammation in a mouse model of recurrent psoriasis. Front Immunol. 2025 Jun 17;16:1574455. doi: 10.3389/fimmu.2025.1574455. eCollection 2025.
- Derived from this study: PubMed 32318062Casciano F, Diani M, Altomare A, Granucci F, Secchiero P, Banfi G, Reali E. CCR4+ Skin-Tropic Phenotype as a Feature of Central Memory CD8+ T Cells in Healthy Subjects and Psoriasis Patients. Front Immunol. 2020 Apr 3;11:529. doi: 10.3389/fimmu.2020.00529. eCollection 2020.
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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.
Eva Reali, Dr. principal investigator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
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 and Psoriatic Arthritis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 4 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 9 Sep 2019. 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 Italy. 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?
Evaluation of the percentage of different subsets of memory T cells in the circulation of patients with psoriasis, patients with psoriatic arthritis and a control group of healthy subject. (time frame: At time of blood collection). 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 NCT03374527, which also lists 4 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 9 Sep 2019.