NCT00669214已完成4 期
A Phase IV Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of 1.0 mg/kg Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp
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
- 89
- 主要终点
- Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks
研究概览
简要总结
This was a Phase IV randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of subcutaneous efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis with involvement of the scalp who had no previous exposure to efalizumab. The study consisted of a screening period, a double-blind treatment period, an open-label treatment period, and an observation/follow-up period. The study enrolled 100 patients. 11 patients were excluded from all analyses because of data issues.
详细描述
- Baselines for Raptiva group and placebo group at Day 84 are the same. The baseline is Day 0.
- Baselines for Raptiva group and placebo group at Day 168 are different. The baseline for Raptiva group at Day 168 is Day 0, but the baseline for Placebo group at Day 168 is Day 84
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
- Double (Participant, Investigator)
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
- •Provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents
- •Be aged 18 years or older
- •Have chronic (6 months or greater) moderate to severe plaque psoriasis with involvement of the scalp
- •Have a whole body Physician's Global Assessment (PGA) rating of moderate (3) or severe (4) for psoriasis
- •Have a scalp surface area affected by plaque psoriasis of 30% or more, assessed using Psoriasis Scalp Severity Index (PSSI)
- •Have at least one of three clinical signs involving the scalp (erythema, induration, and desquamation) be rated as at least moderate (2) with the other two rated as at least slight (1) using PSSI
- •Be a candidate for systemic therapy in the opinion of the investigator
- •Be naive to efalizumab treatment
- •For women of childbearing potential, must be willing to use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab
排除标准
- •Have had previous exposure to efalizumab or a history of hypersensitivity to any of its components
- •Are using any excluded therapy
- •Have a history of drug or alcohol abuse in the past five years
- •Have a history in the past 5 years of a serious infection or currently have an ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
- •Have any history of opportunistic infections (e.g., systemic fungal infections, parasites)
- •Are seropositive for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)
- •Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis, including latent tuberculosis with isoniazid
- •Have the presence or history of malignancy within the past 5 years, including lymphoproliferative disorders
- •Are pregnant or breastfeeding
- •Have a diagnosis of hepatic cirrhosis, regardless of cause or severity
- •Have a history in the last 5 years of thrombocytopenia
- •Have a history in the last 5 years of hemolytic anemia or any other clinically significant anemia
- •Have been exposed to any experimental and/or unapproved drugs or treatments within 30 days or 5 half-lives, whichever is longer, before the screening visit
- •Have been vaccinated with a live virus or live bacteria within the 14 days before the first dose of efalizumab
- •Have any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug (efalizumab or placebo equivalent) or would significantly interfere with the patient's ability to comply with the provisions of this protocol
研究组 & 干预措施
Efalizumab
Experimental
干预措施: efalizumab (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks
时间窗: Week 12
Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = \<10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.
次要结局
- Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks(Week 24)
- Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks(Week 12)
- Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks(Week 24)
- Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks(Week 12)
- Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks(Week 24)
- Mean Change in Scalpdex Score at 12 Weeks(The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84)
- Mean Change in Scalpdex Score at 24 Weeks(Week 24)
- Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks(Week 12)
- Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks(Week 24)
- Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks(Week 12)
- Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks(Week 24)
研究者
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