NCT00235820已完成3 期
A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate 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
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.
研究概览
简要总结
Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic 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
- Double (Participant, 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
- •Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis
- •Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents.
- •Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections.
- •Male subjects must hve been vasectomized or practicing birth control.
排除标准
- •Previous systemic anti-TNF therapy.
- •Prior use of MTX.
- •Known hypersensitivity to the constituents of adalimumab.
- •Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies, which must be discontinued at least 12 weeks prior to enrollment.
- •Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
- •Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline.
- •Use of PUVA for at least 4 weeks prior to Baseline.
- •Use of oral or injectable corticosteroids during the study.
- •Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
- •Female subject who is pregnant or breast feeding or considering becoming pregnant.
研究组 & 干预措施
A
Active Comparator
干预措施: adalimumab (Drug)
B
Active Comparator
干预措施: MTX (Drug)
C
Placebo Comparator
干预措施: placebo adalimumab, placebo MTX (Drug)
结局指标
主要结局
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.
时间窗: Week 16
Safety parameters
时间窗: Every Study Visit
次要结局
- Physician Global Assessment(Baseline - Week 16)
- PASI 50/90/100(Baseline - Week 16)
- DLQI(Baseline - Week 16)
研究者
研究点 (1)
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