Efficacy and Safety of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Psoriasis area and severity index
研究概览
简要总结
Psoriasis is a long standing inflammatory, autoinflammatory disease linked with many comorbidities. Patients with moderate to severe plaque psoriasis can be managed with topical as well as systemic medications. FDA approved Apremilast as first drug to be taken orally in cases of psoriasis in mid 1990's. Currently, according to researchers best knowledge no study has been done on use of Apremilast in Pakistan. It has recently become available here. Keeping in view all the benefits of this drug, a study has been planned to check its effectiveness and safety 30mg twice a day, in patients with moderate to severe chronic plaque psoriasis based on Psoriasis area and severity index and Body surface area assessments in our population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed patients of chronic plaque psoriasis
- •patients applicant for oral or parenteral treatments and for light therapy
- •patients not responding to topical treatments
排除标准
- •Patients who show hypersensitive reactions to apremilast to any of its inactive component
- •Pregnancy
- •Lactating mothers
研究组 & 干预措施
Apremilast 30 mg twice daily
干预措施: Apremilast 30mg (Drug)
结局指标
主要结局
Psoriasis area and severity index
时间窗: 16 weeks
body surface area
时间窗: 16 weeks
次要结局
未报告次要终点