A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- PASI (Psoriasis Area and Severity Index)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Psoriasis patients
- •Psoriatic arthritis patients
- •Agree to provide a blood sample
排除标准
- •A current history of cancer,
- •Recent hospitalization for infection or current antibiotic treatment
- •HIV infection.
研究组 & 干预措施
Prescreen Based bDMARD Stategic Treatment Group
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
干预措施: Prescreen platform (Diagnostic Test)
Prescreen Based bDMARD Stategic Treatment Group
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
干预措施: biologics treatment (Biological)
Standard bDMARD Treatment Group
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.
干预措施: biologics treatment (Biological)
结局指标
主要结局
PASI (Psoriasis Area and Severity Index)
时间窗: 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
时间窗: 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
次要结局
- BSA (body surface area)(From enrollment to the end of treatment at 48 weeks)
- Pruritus score(From enrollment to the end of treatment at 48 weeks)
- Swelling joint counts(From enrollment to the end of treatment at 48 weeks)
- Tender joint counts(From enrollment to the end of treatment at 48 weeks)
- Dermatology Life Quality Index (DLQI)(From enrollment to the end of treatment at 48 weeks)