NCT00287547已完成2 期
Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Bristol-Myers Squibb10 个研究点 分布在 1 个国家目标入组 144 人开始时间: 1997年3月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 10
- 主要终点
- Using the Psoriasis Disablity Index (PDI) and other assessment tools to determine if the patient's psoriasis improved or worsened over the course of the study.
研究概览
简要总结
The purpose of this study is to assess the safety, pharmacokinetics and clinical activity and immunogenicity of BMS-188667 (CTLA4Ig) in subjects with psoriasis vulgaris
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis and documentation of a history of stable psoriasis vulgaris of at least 6 months duration.
- •vulgaris total body surfae area involvement of at least 10%
- •Failure for toxicity and/or inefficacy of at least one standard anti- psoriatic therapy including topical treatment, phototherapy, photochemotherapy, methotrexate, cyclosporin A or etretinate.
排除标准
- •Male and female subjects who are not willing to receive adequate counseling and exercise adequate contraceptive measures with enrolle on study.
- •Functional class (V (ACR) RA or amyloidosis)
- •Active vasculitis (except for subcutaneous rheumatoid nodules).
- •Subjects with a history of asthma, angioedema or anaphylaxis.
- •Subjects with evidence of active or latent bacterial or viral invedtions.
- •Subjects with a history or malignancy (except basal cell or superficial squamous cell skin carcinoma).
- •body weight > 100 kg (or 220 lbs.)
结局指标
主要结局
Using the Psoriasis Disablity Index (PDI) and other assessment tools to determine if the patient's psoriasis improved or worsened over the course of the study.
次要结局
- Safety and immunogenicity; pharmacodynamic and PK; Percent reduction in PASI, PASI component scores and Total Body Surface Area; Clinical response kinetics; clinical relapse kinetics; physician global assessment; psoriasis disability index.
研究者
研究点 (10)
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