Non-interventional Study Of The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 126
- 试验地点
- 8
- 主要终点
- Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
研究概览
简要总结
Pilot observational study to describe the relationship between the smoking status of a psoriatic individual and the success of etanercept therapy in psoriasis treatment
详细描述
non-interventional study There is no sampling
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic plaque type psoriasis for at least 6 months as determined by the subjects medical history, and confirmation of the diagnosis through physical examination by the investigator Patients who are scheduled by their dermatologist to initiate treatment with Etanercept
排除标准
- •Previous or current treatment with antipsoriatic biologic drugs, such as etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab Chronic or acute infections requiring intravenous or oral anti-infectives within 14 days prior to the Baseline visit
结局指标
主要结局
Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24
时间窗: Baseline (Day 1), Week 24
PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck \[h\], arms \[u\], trunk \[t\], legs \[l\]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.
次要结局
- Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24(Week 12, 24)
- Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24(Baseline, Week 12, 24)
- Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12(Baseline, Week 12)