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
- 183
- 试验地点
- 29
- 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
The main purpose of this study is to assess the effect of smoking status on the success of Etanercept therapy in patients with moderate-to-severe psoriasis.
详细描述
Study hypothesis was based on the following rationale:
- Psoriasis vulgaris is a chronic inflammatory skin disease with several extracutaneous manifestations and significant comorbidities (among others cardiovascular disease, metabolic syndrome, obesity and depression).
- An increased prevalence of smoking among psoriasis patients, as compared with healthy subjects, has been observed in several studies
- More recent studies suggest that cigarette smoking may trigger the development of psoriasis through oxidative, inflammatory and genetic mechanisms.Furthermore, smoking is associated with the clinical severity of psoriasis
- Smoking also contributes to higher morbidity and mortality from smoking related disorders in these patients There is now some evidence that patients with psoriasis who smoke tend to be less responsive to treatment
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged ≥18 years at the time of screening
- •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 prescribed independently by the investigator as per local clinical practice guideline
- •Stable plaque psoriasis for at least 2 months prior to Baseline
- •Diagnosis of severe psoriasis defined as PASI > 10
- •Eligible for Etanercept treatment according to Summary of Product Characteristics (SmPC)
- •Smokers with smoking >10 cigarettes daily for smokers group (Group 1) or non-smokers for non-smoking group (Group 2)
- •Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study
排除标准
- •Previous or current treatment with antipsoriatic biologic drugs, such as Etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab.
- •Exclusion Criteria according to the Enbrel® SmPC, with particular attention to: hypersensitivity to the active substance (etanercept) or to any of the excipients; sepsis or risk of sepsis, active infections, including chronic or localised infections.
- •Positive pregnancy test, breast feeding or considering becoming pregnant during the study
- •Clinically significant drug or alcohol abuse
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, Week 24
PASI 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 on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section\*area score\*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
次要结局
- Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12(Week 12)
- Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24(Week 12, 24)
- Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants(Baseline, Week 12, 24)
- Change From Baseline in Dermatology Life Quality Index (DLQI)(Baseline, Week 12, 24)
- Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24(Week 12, 24)