PsoriasisPhase 4SMILENCT07149792
A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers
A Phase 4 study testing Prescreen platform and biologics treatment in people with Psoriasis and Psoriasis Arthritis, run by Taichung Veterans General Hospital at 2 sites in Taiwan.
Trial summary
The inclusion criteria for this study were patients aged 18 to 75 years with a confirmed diagnosis of psoriasis by a dermatologist or psoriatic arthritis by a rheumatologist. Patients with active infections or suspected malignancies were excluded. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Psoriasis Arthritis, Biologics
- What is being tested?
- Prescreen platform and biologics treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTaiwan
- Study dates
- 29 Jul 2025to 1 Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Healthy subjects
- Psoriasis patients
- Psoriatic arthritis patients
- Agree to provide a blood sample
Who cannot join
- A current history of cancer,
- Recent hospitalization for infection or current antibiotic treatment
- HIV infection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
Taichung Veterans Hospital
Taichung, Taiwan, 407219
- Recruiting
Taichung Vertenans General Hospital
Taichung, Taiwan, 886
James Yen, PhD, 886-4-23592525 ext. 5301, vernayen@yahoo.com.tw
About this study
The inclusion criteria for this study were patients aged 18 to 75 years with a confirmed diagnosis of psoriasis by a dermatologist or psoriatic arthritis by a rheumatologist. Patients with active infections or suspected malignancies were excluded.
A total of 40 patients with psoriasis, with or without psoriatic arthritis, were enrolled from multiple centers in Taiwan. All participants were recruited from the outpatient clinics of either the Department of Allergy, Immunology, and Rheumatology or the Department of Dermatology in tertiary hospitals across Taiwan.
Read more
Participants were randomly assigned to one of two groups:
Prescreen Strategy-Based Biologics Selection Group
Standard-Based Biologics Selection Group
Patients will be followed up at weeks 4, 8, 12, 24, 32, 40, 48, 56, 64, and 72. Follow-up may be extended up to 3 years if necessary.
Clinical assessments will include:
Primary endpoints: PASI (Psoriasis Area and Severity Index), painful joint count, swollen joint count, and DAPSA (Disease Activity in Psoriatic Arthritis) score.
Secondary endpoints: DLQI (Dermatology Life Quality Index), BSA (Body Surface Area), pruritus score, and internal carotid artery thickness measured at 6 months, 1 year, and 2 years.
Read the detailed description
To prepare the PBMC (peripheral blood mononuclear cell) culture, 16 mL of peripheral blood is collected from each patient using sodium citrate tubes (Vacutainer CPT, BD Biosciences, Franklin Lakes, NJ, USA). PBMCs are isolated by centrifugation at 1800 × g for 20 minutes at room temperature with the brake turned off, resulting in the separation of plasma, PBMCs, gel plugs, and red blood cell (RBC) layers.
The isolated PBMCs are washed with phosphate-buffered saline (PBS) and then cultured in RPMI-1640 medium supplemented with 10% fetal bovine serum (FBS) and 1% penicillin/streptomycin at 37 °C in a 5% CO₂ incubator.
A total of 6 × 10⁵ cells/mL are seeded into 12-well plates and treated for 24 hours under the following conditions:
Control
Streptococcus pyogenes only
- pyogenes + adalimumab (4 μg/mL)
- pyogenes + golimumab (0.5 μg/mL)
- pyogenes + certolizumab (20 μg/mL)
- pyogenes + ustekinumab (0.25 μg/mL)
- pyogenes + ixekizumab (3.5 μg/mL)
- pyogenes + secukinumab (16.7 μg/mL or 34 μg/mL)
- pyogenes + guselkumab (1.2 μg/mL)
- pyogenes + risankizumab (2 μg/mL)
Culture supernatants are collected for subsequent cytokine measurement. The concentrations of biological agents used correspond to the trough serum concentrations at steady state as indicated in the pharmacokinetic sections of reference data. The two concentrations of secukinumab (16.7 μg/mL and 34 μg/mL) reflect the two common clinical doses of 150 mg and 300 mg per month, respectively.
Cytokine Analysis
Cytokine levels are measured in the collected supernatants using a protein multiplex immunoassay system (Bio-Plex Cytokine Array System, Bio-Rad Laboratories, Hercules, CA, USA). The following cytokines and chemokines are analyzed:
IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, IFN-γ, TNF-α, monocyte chemoattractant protein-1 (MCP-1), macrophage inflammatory proteins (MIP-1α and MIP-1β), platelet-derived growth factor-BB (PDGF-BB), and chemokine (CC motif) ligand 5 (RANTES).
Screening Method for Biologic Agents
RANTES Exclusion First, biologics that induce a RANTES level ≥1.5 times higher than that of S. pyogenes-only treatment are excluded.
Scoring System for Biologic Selection in Psoriasis
Remaining biologics are categorized into three grades based on biomarker levels:
IFN-γ
IL-17A
IFN-γ/IL-4
IFN-γ/IL-13
IL-17A/IL-4
IL-17A/IL-13
Grade 1 (Most appropriate): Lowest biomarker values
Grade 2 (Possibly appropriate): Intermediate values
Grade 3 (Not recommended): Highest values
Each grade is subdivided into a, b, and c groups:
Lower values within a grade are ranked as a, followed by b, then c
Scoring is as follows:
- a = +3, 1b = +2, 1c = +1.5
- a = +1, 2b = +0.5, 2c = 0
- a = -0.5, 3b = -1, 3c = -1.5
The total score for each biologic is the sum of individual biomarker scores. Based on total scores:
High score = Most appropriate
Medium score = Possibly appropriate
Low score = Not recommended
Scoring for Psoriatic Arthritis (PsA)
For PsA, biologics are selected based on the lowest RANTES, MCP-1 and IFN-γ levels:
Grade 1 (Most appropriate): Lowest biomarker values Grade 2 (Possibly appropriate): Intermediate values Grade 3 (Not recommended): Highest values RANTES: 2+, 1+, 0 MCP-1: 1+, 0.5+, 0 IFN-γ: 1+, 0.5+, 0 The final score is the sum of RANTES MCP-1 and IFN-γ scores. Biologics with the lowest total scores are preferred.
Patient Assignment in Strategic Group
Biologics from the "most appropriate" group are selected for each patient in the strategic group. The following clinical indicators are monitored over time:
Absolute PASI
Tender joint count
Swollen joint count
DAPSA score
DLQI
Internal carotid artery intima thickness
Follow-up Timeline
Clinical assessments: Weeks 0, 2, 4, 12, 24, and 48
Intima thickness: Weeks 0 and 48
Outcome Comparison Outcomes between the strategic selection group and standard care group are compared at Weeks 24 and 48, with extended follow-up up to 5 years. Primary outcomes include PASI and DLQI scores.
Statistical Analysis
All statistical analyses are conducted using SPSS version 22 (IBM, Armonk, NY, USA). Demographic and clinical characteristics, as well as outcome measures (PASI, joint counts, DAPSA, DLQI, and carotid intima thickness), are analyzed using the Mann-Whitney U test and Spearman's rho correlation.
Data are presented as mean ± standard deviation. Two-sided p values < 0.05 are considered statistically significant.
- Conditions
- Psoriasis, Psoriasis Arthritis, Biologics
- Being tested
- Prescreen platform, biologics treatment
- Keywords
- Prescreen, Biologics, Psoriasis, Strategic selection, 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.
Prescreen platformDiagnostic test
Different biomarkers on PsO, PsA and paradoxical PsA
biologics treatmentBiological
All psoriasis patients are receiving biologics treatment
| Study group | Role | What they receive |
|---|---|---|
| Prescreen Based bDMARD Stategic Treatment Group | Experimental | Strategic groups: This group patients prescreen to various biologics (such as Adalimumab (Humira), Etanercept (Enbrel), Certolizumab pegol (Cimzia) Golimumab (Simponi), Ustekinumab (Stelara),Secukinumab (Cosentyx) Ixekizumab (Taltz),Bimekizumab (Bimzelx), Brodalumab (Lumicef)) on their immune cells and choose the most proper biologics according to a set of biomarkers for individual psoriasis patient before starting the treatment Receives: Diagnostic Test: Prescreen platform; Biological: biologics treatment |
| Standard bDMARD Treatment Group | Active comparator | This group patients receive biologics treatment (such as Adalimumab (Humira), Etanercept (Enbrel), Certolizumab pegol (Cimzia) Golimumab (Simponi), Ustekinumab (Stelara),Secukinumab (Cosentyx) Ixekizumab (Taltz),Bimekizumab (Bimzelx), Brodalumab (Lumicef)) according to present guideline without individuals immune cells screen. Receives: Biological: biologics treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASI (Psoriasis Area and Severity Index)
The skin condition of psoriasis patients is assessed using the PASI (Psoriasis Area and Severity Index), which ranges from 0 to 72, with higher scores indicating more severe disease
Measured: From enrollment to the end of treatment at 48 weeks
DAPSA Score - Disease Activity in Psoriatic Arthritis
DAPSA Formula (Total Score):
DAPSA = TJC (68)
+ SJC (66)
+ Patient Global Assessment (0-10)
+ Patient Pain Assessment (0-10)
+ CRP (mg/dL) DAPSA=TJC (68)+SJC (66)+Patient Global Assessment (0-10)+Patient Pain Assessment (0-10)+CRP (mg/dL)
Where:
TJC = Tender Joint Count (out of 68 joints)
SJC = Swollen Joint Count (out of 66 joints)
Patient Global Assessment (PtGA) = Patient's rating of overall disease activity (0-10 scale)
Pain VAS = Patient's self-reported pain (0-10 scale)
CRP = C-reactive protein level (mg/dL)
Interpreting DAPSA Scores:
DAPSA Score and Disease Activity Level
≤4 Remission, >4-14 Low disease activity, >14-28 Moderate disease activity, >28 High disease activity
Measured: From enrollment to the end of treatment at 48 weeks
Secondary outcomes (5)
BSA (body surface area)
The severity of psoriatic disease can be assessed using the Body Surface Area (BSA) score, which ranges from 0 to 100%. A higher BSA score indicates more extensive and severe skin involvement
Measured: From enrollment to the end of treatment at 48 weeks
Pruritus score
The severity of psoriatic disease can be assessed using the pruritus score, which ranges from 0 to 10. A higher pruritus score indicates more severe skin involvement
Measured: From enrollment to the end of treatment at 48 weeks
Swelling joint counts
0 swollen joints = No active synovitis (remission or well-controlled disease)
Higher counts = More active joint inflammation and more severe disease
Measured: From enrollment to the end of treatment at 48 weeks
Tender joint counts
0 tender joints = No current joint pain (remission or well-controlled disease) Higher TJC = Greater disease burden or active joint inflammation
Measured: From enrollment to the end of treatment at 48 weeks
Dermatology Life Quality Index (DLQI)
The DLQI (Dermatology Life Quality Index) score ranges from 0 to 30, with higher scores indicating a greater impact of the disease on the patient's quality of life
Measured: From enrollment to the end of treatment at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start29 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The psoriasis patients are arranged randomly by two groups: 1. Strategic groups: This group patients prescreen to various biologics on their immune cells and choose the most proper biologics according to a set of biomarkers for individual psoriasis patient before starting the treatment. 2. Standard groups: This group patients receive biologics treatment according to present guideline without individual immune cells screen. The patients are enrolled need washout bioloigics1 month but dMARD is exceptional. We will collect the clinical data including PASI, BSA, Pruritus score, Swelling joint counts, Tender joint counts, DAPSA score, DLQI score in the follwing timetable to 3 years.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Chung Shan Medical University, Far Eastern Memorial Hospital, China Medical University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149792
- Sponsor's protocol ID
- Taichung VGH Derm Yen
- Other IDs
- TCVGH-1445602C
- Acronym
- SMILE
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers
- ClinicalTrials.gov ID
- NCT07149792
- Acronym / sponsor ID
- SMILE / Taichung VGH Derm Yen
- Conditions
- Psoriasis, Psoriasis Arthritis, Biologics
- Keywords
- Prescreen, Biologics, Psoriasis, Strategic selection, Psoriatic arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, Chung Shan Medical University, Far Eastern Memorial Hospital, China Medical University Hospital
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 2 Sep 2025 (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 inclusion criteria for this study were patients aged 18 to 75 years with a confirmed diagnosis of psoriasis by a dermatologist or psoriatic arthritis by a rheumatologist. Patients with active infections or suspected malignancies were excluded.
A total of 40 patients with psoriasis, with or without psoriatic arthritis, were enrolled from multiple centers in Taiwan. All participants were recruited from the outpatient clinics of either the Department of Allergy, Immunology, and Rheumatology or the Department of Dermatology in tertiary hospitals across Taiwan.
Participants were randomly assigned to one of two groups:
Prescreen Strategy-Based Biologics Selection Group
Standard-Based Biologics Selection Group
Patients will be followed up at weeks 4, 8, 12, 24, 32, 40, 48, 56, 64, and 72. Follow-up may be extended up to 3 years if necessary.
Clinical assessments will include:
Primary endpoints: PASI (Psoriasis Area and Severity Index), painful joint count, swollen joint count, and DAPSA (Disease Activity in Psoriatic Arthritis) score.
Secondary endpoints: DLQI (Dermatology Life Quality Index), BSA (Body Surface Area), pruritus score, and internal carotid artery thickness measured at 6 months, 1 year, and 2 years.
Detailed description
To prepare the PBMC (peripheral blood mononuclear cell) culture, 16 mL of peripheral blood is collected from each patient using sodium citrate tubes (Vacutainer CPT, BD Biosciences, Franklin Lakes, NJ, USA). PBMCs are isolated by centrifugation at 1800 × g for 20 minutes at room temperature with the brake turned off, resulting in the separation of plasma, PBMCs, gel plugs, and red blood cell (RBC) layers.
The isolated PBMCs are washed with phosphate-buffered saline (PBS) and then cultured in RPMI-1640 medium supplemented with 10% fetal bovine serum (FBS) and 1% penicillin/streptomycin at 37 °C in a 5% CO₂ incubator.
A total of 6 × 10⁵ cells/mL are seeded into 12-well plates and treated for 24 hours under the following conditions:
Control
Streptococcus pyogenes only
- pyogenes + adalimumab (4 μg/mL)
- pyogenes + golimumab (0.5 μg/mL)
- pyogenes + certolizumab (20 μg/mL)
- pyogenes + ustekinumab (0.25 μg/mL)
- pyogenes + ixekizumab (3.5 μg/mL)
- pyogenes + secukinumab (16.7 μg/mL or 34 μg/mL)
- pyogenes + guselkumab (1.2 μg/mL)
- pyogenes + risankizumab (2 μg/mL)
Culture supernatants are collected for subsequent cytokine measurement. The concentrations of biological agents used correspond to the trough serum concentrations at steady state as indicated in the pharmacokinetic sections of reference data. The two concentrations of secukinumab (16.7 μg/mL and 34 μg/mL) reflect the two common clinical doses of 150 mg and 300 mg per month, respectively.
Cytokine Analysis
Cytokine levels are measured in the collected supernatants using a protein multiplex immunoassay system (Bio-Plex Cytokine Array System, Bio-Rad Laboratories, Hercules, CA, USA). The following cytokines and chemokines are analyzed:
IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, IFN-γ, TNF-α, monocyte chemoattractant protein-1 (MCP-1), macrophage inflammatory proteins (MIP-1α and MIP-1β), platelet-derived growth factor-BB (PDGF-BB), and chemokine (CC motif) ligand 5 (RANTES).
Screening Method for Biologic Agents
RANTES Exclusion First, biologics that induce a RANTES level ≥1.5 times higher than that of S. pyogenes-only treatment are excluded.
Scoring System for Biologic Selection in Psoriasis
Remaining biologics are categorized into three grades based on biomarker levels:
IFN-γ
IL-17A
IFN-γ/IL-4
IFN-γ/IL-13
IL-17A/IL-4
IL-17A/IL-13
Grade 1 (Most appropriate): Lowest biomarker values
Grade 2 (Possibly appropriate): Intermediate values
Grade 3 (Not recommended): Highest values
Each grade is subdivided into a, b, and c groups:
Lower values within a grade are ranked as a, followed by b, then c
Scoring is as follows:
- a = +3, 1b = +2, 1c = +1.5
- a = +1, 2b = +0.5, 2c = 0
- a = -0.5, 3b = -1, 3c = -1.5
The total score for each biologic is the sum of individual biomarker scores. Based on total scores:
High score = Most appropriate
Medium score = Possibly appropriate
Low score = Not recommended
Scoring for Psoriatic Arthritis (PsA)
For PsA, biologics are selected based on the lowest RANTES, MCP-1 and IFN-γ levels:
Grade 1 (Most appropriate): Lowest biomarker values Grade 2 (Possibly appropriate): Intermediate values Grade 3 (Not recommended): Highest values RANTES: 2+, 1+, 0 MCP-1: 1+, 0.5+, 0 IFN-γ: 1+, 0.5+, 0 The final score is the sum of RANTES MCP-1 and IFN-γ scores. Biologics with the lowest total scores are preferred.
Patient Assignment in Strategic Group
Biologics from the "most appropriate" group are selected for each patient in the strategic group. The following clinical indicators are monitored over time:
Absolute PASI
Tender joint count
Swollen joint count
DAPSA score
DLQI
Internal carotid artery intima thickness
Follow-up Timeline
Clinical assessments: Weeks 0, 2, 4, 12, 24, and 48
Intima thickness: Weeks 0 and 48
Outcome Comparison Outcomes between the strategic selection group and standard care group are compared at Weeks 24 and 48, with extended follow-up up to 5 years. Primary outcomes include PASI and DLQI scores.
Statistical Analysis
All statistical analyses are conducted using SPSS version 22 (IBM, Armonk, NY, USA). Demographic and clinical characteristics, as well as outcome measures (PASI, joint counts, DAPSA, DLQI, and carotid intima thickness), are analyzed using the Mann-Whitney U test and Spearman's rho correlation.
Data are presented as mean ± standard deviation. Two-sided p values < 0.05 are considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The psoriasis patients are arranged randomly by two groups: 1. Strategic groups: This group patients prescreen to various biologics on their immune cells and choose the most proper biologics according to a set of biomarkers for individual psoriasis patient before starting the treatment. 2. Standard groups: This group patients receive biologics treatment according to present guideline without individual immune cells screen. The patients are enrolled need washout bioloigics1 month but dMARD is exceptional. We will collect the clinical data including PASI, BSA, Pruritus score, Swelling joint counts, Tender joint counts, DAPSA score, DLQI score in the follwing timetable to 3 years.
| Arm | Type | Receives |
|---|---|---|
| Prescreen Based bDMARD Stategic Treatment Group | Experimental | Diagnostic Test: Prescreen platform, Biological: biologics treatmentStrategic groups: This group patients prescreen to various biologics (such as Adalimumab (Humira), Etanercept (Enbrel), Certolizumab pegol (Cimzia) Golimumab (Simponi), Ustekinumab (Stelara),Secukinumab (Cosentyx) Ixekizumab (Taltz),Bimekizumab (Bimzelx), Brodalumab (Lumicef)) on their immune cells and choose the most proper biologics according to a set of biomarkers for individual psoriasis patient before starting the treatment |
| Standard bDMARD Treatment Group | Active comparator | Biological: biologics treatmentThis group patients receive biologics treatment (such as Adalimumab (Humira), Etanercept (Enbrel), Certolizumab pegol (Cimzia) Golimumab (Simponi), Ustekinumab (Stelara),Secukinumab (Cosentyx) Ixekizumab (Taltz),Bimekizumab (Bimzelx), Brodalumab (Lumicef)) according to present guideline without individuals immune cells screen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects
- Psoriasis patients
- Psoriatic arthritis patients
- Agree to provide a blood sample
Key exclusion criteria (3 listed)
- A current history of cancer,
- Recent hospitalization for infection or current antibiotic treatment
- HIV infection.
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 |
|---|---|---|
| Prescreen platformDifferent biomarkers on PsO, PsA and paradoxical PsA | Diagnostic test | Prescreen Based bDMARD Stategic Treatment Group |
| biologics treatmentAll psoriasis patients are receiving biologics treatment | Biological | Prescreen Based bDMARD Stategic Treatment Group, Standard bDMARD Treatment Group |
Primary outcome
PASI (Psoriasis Area and Severity Index)
Time frame: From enrollment to the end of treatment at 48 weeks
The skin condition of psoriasis patients is assessed using the PASI (Psoriasis Area and Severity Index), which ranges from 0 to 72, with higher scores indicating more severe disease
DAPSA Score - Disease Activity in Psoriatic Arthritis
Time frame: From enrollment to the end of treatment at 48 weeks
DAPSA Formula (Total Score): DAPSA = TJC (68) + SJC (66) + Patient Global Assessment (0-10) + Patient Pain Assessment (0-10) + CRP (mg/dL) DAPSA=TJC (68)+SJC (66)+Patient Global Assessment (0-10)+Patient Pain Assessment (0-10)+CRP (mg/dL) Where: TJC = Tender Joint Count (out of 68 joints) SJC = Swollen Joint Count (out of 66 joints) Patient Global Assessment (PtGA) = Patient's rating of overall disease activity (0-10 scale) Pain VAS = Patient's self-reported pain (0-10 scale) CRP = C-reactive protein level (mg/dL) Interpreting DAPSA Scores: DAPSA Score and Disease Activity Level ≤4 Remission, >4-14 Low disease activity, >14-28 Moderate disease activity, >28 High disease activity
5 secondary outcomes
BSA (body surface area)
Time frame: From enrollment to the end of treatment at 48 weeks
Pruritus score
Time frame: From enrollment to the end of treatment at 48 weeks
Swelling joint counts
Time frame: From enrollment to the end of treatment at 48 weeks
Tender joint counts
Time frame: From enrollment to the end of treatment at 48 weeks
Dermatology Life Quality Index (DLQI)
Time frame: From enrollment to the end of treatment at 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prescreen platform and biologics treatment in people with Psoriasis and Psoriasis Arthritis, run by Taichung Veterans General Hospital at 2 sites in Taiwan.
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 3 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: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Yen, MD PhD (886-4-23592525 ext. 5303 or 5301, vernayen@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PASI (Psoriasis Area and Severity Index) (time frame: From enrollment to the end of treatment at 48 weeks). The study lists 2 primary outcomes in all. 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 2 Sep 2025.