Therapeutic Effect of Granulocytapheresis in Psoriasis (GRIP-study)Using a Novel Cellulose-based Adsorber Device
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- >/=75 % Improvement in PASI (Psoriasis Area and Severity Index) on an Intention-to-treat Basis
研究概览
简要总结
In a prospective, randomized, controlled, double-blinded, multicenter study, granulocytapheresis using a novel cellulose-based adsorber will be compared to control sham treatment (placebo). The effects on clinical symptoms and on some inflammatory parameters of patients with moderate to severe plaque psoriasis will be evaluated over a 24-week period.
The primary end-point is a ≥75 percent improvement in PASI (Psoriasis Area and Severity Index).
The study purpose is to demonstrate a beneficial therapeutic effect of granulocytapheresis using the novel cellulose-based adsorber device in moderate to severe plaque psoriasis.
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, Outcomes Assessor)
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
- •Moderate to severe plaque psoriasis with a PASI >/=10
- •Age >/= 18 years
- •Negative pregnancy test in woman of childbearing age acceptable method of contraception for both men and women
- •Written informed consent that can be withdrawn at any time or for any reason
- •Discontinuation of any systemic psoriasis treatment. Washout period of at least two weeks for prior systemic medications
- •Only emollients for topical treatment
- •No vaccinations for at least 14 days prior to first treatment
排除标准
- •Other forms of psoriasis (e.g., guttate, pustular, erythrodermic, palmoplantar etc.)
- •History of ongoing uncontrolled bacterial, fungal or viral infection (including opportunistic infections); HIV positivity
- •Pregnancy
- •Clinically relevant thrombocytopenia or bleeding disorders
- •WBC <4.000 or >12.000/µl
- •Malignancy within the last five years (exception: successfully treated basal cell carcinoma or squamous cell carcinoma of the skin)
- •Severe cardiac disorders, stroke, pulmonary disease within the last year
- •Any medical condition that, in the judgment of the investigators, would jeopardize the patient's safety during the study
结局指标
主要结局
>/=75 % Improvement in PASI (Psoriasis Area and Severity Index) on an Intention-to-treat Basis
时间窗: At the end of the granulocytapheresis treatment period
次要结局
- Patients Achieving an Improvement of PASI by >/= 50%(From baseline to weeks 2, 6, 12 and 24)