To Observe the Effectiveness and Safety of Anti-TNFs in Patients With Moderate to Severe Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 103
- 试验地点
- 25
- 主要终点
- Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
研究概览
简要总结
In recent years, biologics have changed the treatment of psoriasis, giving us additional therapeutic options that are potentially less toxic to the liver, kidneys, and bone marrow and are not teratogenic. Nevertheless, traditional systemic therapies continue to play an important role in the treatment of psoriasis in Turkey, even in patients who are requiring biologic treatments according to national recommendations. This study is designated to observe the effectiveness and safety of tumor necrosis factor inhibitors in patients with moderate to severe psoriasis.
详细描述
Patients admitted to dermatology clinics, with moderate to severe psoriasis for whom the physician has decided to initiate psoriasis treatment with anti-TNFs in accordance with Turkish Ministry of Health regulations and reimbursements. (Tumor necrosis factor inhibitors can be used for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or Psoralen Ultra-Violet A. Patients should be screened for latent tuberculosis and appropriate anti-tuberculosis prophylaxis must be initiated if latent tuberculosis is diagnosed). This is a national, multi-center, observational, prospective photographic atlas study in patients who are treated with tumor necrosis factor inhibitors for moderate to severe psoriasis in daily clinic according to Turkish regulations and reimbursement. Demographic data will be collected by the investigator at the beginning of the study. Every participant will be examined by the investigator and the Psoriasis Area Severity Index will be determined at the beginning of the study and at weeks 4, 8, 16 and 24. Each patient will be asked to fill out the Dermatology Life Quality Index at each visit. Each patient will be asked to fill out the Work Productivity and Activity Impairment Questionnaire: Psoriasis at the beginning and last visit (week 24). A standardized set of photographs will be taken at the beginning of the study and at weeks 4, 8, 16 and 24 by a dermatologist trained about standardized photograph positioning and settings. Psoriasis Area Severity Index, Dermatology Life Quality Index and Photographic scores will be statistically analyzed separately in order to evaluate treatment response.
研究设计
- 研究类型
- Observational
- 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
- •Male or female patients ≥18 years old with moderate-to-severe psoriasis.
- •Patients for whom the physician has decided to initiate psoriasis treatment with anti-TNFs in accordance with Turkish Ministry of Health regulations and reimbursements.
- •Patients who are able to understand and answer a self administered questionnaire.
- •Patients signed an informed consent form stating that they agreed to have their photographs taken, analyzed, and included in a scientific publication.
排除标准
- •Patients who do not consent to being photographed during the study.
- •Females who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study.
- •Patients with untreated tuberculosis.
结局指标
主要结局
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score
时间窗: Baseline and Weeks 4, 8, 16 and 24
The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from none (0), mild (1), moderate (2), severe (3) or very severe (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from Baseline is presented as a percentage of the Baseline value: Baseline value - post-baseline value / Baseline value \* 100.
Percentage of Participants With 75% Reduction in PASI Score
时间窗: Baseline and Weeks 4, 8, 16 and 24
The percentage of participants with a 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI score is based on an assessment of erythema (reddening), induration (plaque thickness), desquamation (scaling), and the percent area affected as observed on the day of examination. The score ranges from 0 (best outcome) to 72 (worst outcome).
次要结局
- Dynamic Physician Global Assessment (PGA) of Change in Psoriasis(Baseline and Week 24)
- Dynamic Patient Global Assessment (PGA) of Change in Psoriasis(Baseline and Week 24)
- Static Physician Global Assessment (PGA) of Psoriasis(Baseline and Week 24)
- Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score(Baseline and Weeks 4, 8, 16 and 24)
- Percent Change From Baseline in Work Productivity and Activity Impairment(Baseline and Week 24)
- Number of Participants With Adverse Events (AEs)(24 Weeks)
