NCT05863273已完成不适用
Real World Study on the Efficacy and Safety of Apremilast in Chinese Patients with Moderate to Severe Plaque Psoriasis, a Multi Center, Prospective, Observational Trial（REACT）
First Hospital of China Medical University2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2023年5月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- DLQI or PASI improvement
研究概览
简要总结
This is a multicenter, one-arm, prospective, observational study，intended to assess evaluation of efficacy and safety of Apremilast in Chinese patients with moderate-to-severe plaque psoriasis。During this study, it is expected to collect data at at baseline and weeks 2, 6, 10, 16, and 20 after treatment。
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Males or females, ≥ 18 years of age at the time of signing the informed consent document；
- •Patients with moderate-to-severe plaque psoriasis：Simultaneously meet (1)and (2): (1)PASI≥ 3；(2) DLQI ≥ 6；
- •Subject is a candidate for phototherapy and/or systemic therapy
- •Patients who wish to be treated with Apremilast and sign the informed consent
排除标准
- •Allergy to Apremilast or any component of the study drug；
- •Use of phototherapy within 4 weeks prior to randomization；Use of systemic drugs or biologic agents within 4 half-life periods prior to randomization；Patients with inadequate response or intolerance to previous systemic therapy do not need to consider drug washout；
- •Currently using potent cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin, etc.)；
- •History of substance abuse, suicide attempts, or mental illness；
- •Patients who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period；
- •Pustular type, erythroderma type and other psoriasis patients；
- •Other circumstances that investigators don't consider appropriate to include.
研究组 & 干预措施
Apremilast
Dosage of Apremilast（Otezla®） from 10mg qd, titrate to recommended dosage of 30 mg BID，recommended by specification.
干预措施: Apremilast (Drug)
结局指标
主要结局
DLQI or PASI improvement
时间窗: 16 week
At week 16，Proportion of patients with DLQI improvement (DLQI ≤5 or DLQI improvement by ≥4 points from baseline) or PASI improvement (PASI \<3)
次要结局
- PASI, PGA, BSA, DLQI, pruritus VAS and pain VAS(16 week)
- DLQI improvement(10 week)
研究者
Xing hua Gao
First Hospital of China Medical University
First Hospital of China Medical University
研究点 (2)
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