Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 5
- 主要终点
- Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score
研究概览
简要总结
This is a multi-center (North-America), randomized, double-blind, placebo-controlled, wait-list, interventional, preventive trial of guselkumab in high-risk psoriasis patients compared to non-biologic standard of care.
The primary objective of the proposed trial will be to test the hypothesis that a prolonged, unresolved skin inflammation coupled with musculoskeletal power-doppler ultrasound (MSKPDUS) abnormalities driven by IL-23 increase the risk for transition into PsA and that an intervention that targets one of these pivotal molecules (i.e., Guselkumab) will:
- Diminish MSKPDUS findings at 24 weeks, and
- Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants, investigator staff, persons performing the assessments, and the CTT will remain blind to the identity of the treatment from the time of randomization until database lock.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older;
- •Both male & female;
- •Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
- •Willing and able to provide informed consent;
- •Fulfillment of HR-PsO criteria (Psoriasis (PsO) patients will meet the definition of HR if they fulfill the following criteria: a) PsO duration >2 years and Psoriasis Body Surface Area (BSA) >3% and positive imaging findings in MSKPDUS defined as a RM-PsASon score of >3.36
排除标准
- •Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
- •Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment or biologic therapy (ever);
- •RA seropositivity (mid-high RF/ACPA titers);
- •Current active malignancy;
- •History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development
- •Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis;
- •Known hypersensitivity to the study agent.
研究组 & 干预措施
Guselkumab + Topicals (GUS)
干预措施: Guselkumab (Drug)
Placebo + Topicals (PBO)
干预措施: Guselkumab (Drug)
Placebo + Topicals (PBO)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score
时间窗: Baseline, Week 24
Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.
次要结局
- Change in EuroQol-5D (EQ-5D) Score(Baseline, Year 2)
- Severity of PsA at the time of synovio-entheseal development(Year 2)
- Achieved IGA mod 2011 Score(Week 24)
- Change in Ultrasound (US) Score(Baseline, Week 24)
- Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 2(Year 2)
- Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 1(Year 1)
- Change in the ultrasound composite score of synovitis(Baseline, week 24)
- Change in Madrid Sonographic Enthesis Index (MASEI) Score(Baseline, week 24)
- Psoriasis Body Surface Area (BSA)(Week 24)
- Change in Functional Assessment of Chronic Illness Therapy (FACIT) Scale(Week 24)
- Change in International Dermatology Outcome Measures - Musculoskeletal -8 (IDEOM-MSK-8) Score(Baseline, Week 24)
- Proportion of participants who achieved ≥ 50% improvement in US score at 24 weeks(Up to Week 24)