NCT00109252已完成3 期
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab Followed by Efalizumab Taper in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
研究概览
简要总结
This is an open-label, multicenter study designed to evaluate the efficacy and safety of efalizumab administered at weekly SC (subcutaneous) doses of 1.0 mg/kg followed by efalizumab taper in subjects with plaque psoriasis who previously participated in Study ACD2390g.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Previous participation in Study ACD2390g
- •For women of childbearing potential, continued use of an acceptable method of contraception for the duration of their participation in the study
- •Willingness to continue to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources throughout the study
排除标准
- •Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to efalizumab
- •Systemic therapy for psoriasis (ET Day 0 through FU Day 84 or upon relapse or unusual presentation of psoriasis in the FU period, whichever occurs first)
- •Systemic immunosuppressive drugs for other indications (ET Day 0 through FU Day 84)
- •Topical therapies for psoriasis (ET Day 0 through ET Day 84)
- •Live virus or bacteria vaccines (ET Day 0 through FU Day 84)
- •Other vaccines or allergy desensitization (it is recommended that these be scheduled after FU Day 84)
- •Other experimental drugs or treatments (ET Day 0 through FU Day 84)
- •Beta-Blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant between ET Day 0 and TT Day 84)
研究者
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