NCT00658606已完成4 期
Efficacy and Safety of Alefacept in Combination With Narrow-band UVB (nbUVB) Compared to Alefacept Alone in Subjects With Moderate to Severe Chronic Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 98
- 主要终点
- Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16
研究概览
简要总结
Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic subjects as both modalities have an effect on T cells
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has given written informed consent
- •Subject has a diagnosis of moderate to severe chronic plaque psoriasis involving >=10% with a Psoriasis Area and Severity Index (PASI) score >=10 at Baseline
- •Subject has CD4+ T lymphocyte (CD4) count at or above the lower limit of normal
- •Male and female subjects must use an adequate means of contraception from screening to end of study.
排除标准
- •Subject who received alefacept in the past
- •Subject who has shown no improvement following an adequate course of nbUVB in the past
- •Subject who has been treated in the past with either therapy or cyclosporine
- •Subject with any active cancer, including skin cancer at Baseline
- •Subject with erythrodermic, pustular or predominantly guttate psoriasis
- •Subject who has used treatment for psoriasis prior to Baseline as follows:
- •Topical treatment within 14 days
- •Oral treatment within 28 days
- •Broad band UVB (bbUVB) or nbUVB treatment within 56 days
- •Biological treatment within 84 days
- •Serious local infection or serious systemic infection within the 3 months prior to the first dose of study drug
- •Subject with a history of drug or alcohol abuse within the past 2 years
- •Subject that is known to be infected with the AIDS virus
- •Subject with any other skin disease or other disease that might interfere with psoriasis status assessments
- •Female subject who is nursing, pregnant or planning to become pregnant while in this study
- •Subject who is currently enrolled in any other investigational drug or device study
研究组 & 干预措施
Alefacept alone
Active Comparator
15 mg alefacept intramuscularly (IM) once weekly for 12 weeks
干预措施: alefacept (Drug)
Alefacept + nbUVB
Experimental
15 mg alefacept intramuscularly once weekly and narrow band Ultraviolet B (nbUVB) phototherapy 3 times per week for 12 weeks
干预措施: Narrow Band UVB Phototherapy (Procedure)
结局指标
主要结局
Percentage of Subjects Who Achieve Psoriasis Area and Severity Index (PASI) 75 at Week 16
时间窗: Week 16
The PASI score is a tool that allows investigators to assign an objective number to the degree of severity of a person's psoriasis, and considers: redness, scaling and thickness. Values for PASI score range from 0 (least) to 72 (worst). PASI 75 was defined as an improvement of at least 75% in PASI as compared to Baseline. The Last Observation Carry Forward (LOCF) method was used to impute missing data.
次要结局
- Change in Body Surface Area (BSA) Covered With Psoriasis at Week 16(Baseline and Week 16)
- Change in Body Surface Area (BSA) Covered With Psoriasis Over the Entire Course of the Study(Baseline and Week 36)
- Percentage of Subjects Reaching PASI 75 Over the Entire Course of the Study(Week 36)
- Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear at Week 16(Week 16)
- Percentage of Subjects Who Achieved Physical Global Assessment (PGA) of Clear or Almost Clear Over the Entire Course of the Study(Week 36)
- Percentage of Subjects Who Achieve PASI 90 at Week 16(Week 16)
- Time to Relapse(Week 36)
- Time for 50% Decrease in PASI(Week 36)
- Time for a 75% Decrease in PASI(Week 36)
- Change in Dermatology Life Quality Index (DLQI)(Baseline and Week 36)
研究者
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