A Randomized, Blinded Assessor Study to Evaluate the Efficacy and Safety of Etanercept 50 mg Once Weekly Plus As Needed Topical Agent Versus Etanercept 50 mg Twice Weekly in Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24
研究概览
简要总结
To estimate the difference in effectiveness between treatment with etanercept 50 mg twice weekly (BIW) and treatment with etanercept 50 mg once weekly (QW) plus an as needed (PRN) topical agent for 12 weeks in adults with moderate to severe plaque psoriasis.
详细描述
The recommended starting dose of etanercept for adult plaque psoriasis patients is a 50 mg dose given twice a week (BIW) for 3 months followed by a reduction to a maintenance dose of 50 mg once weekly (QW). While most patients with moderate to severe plaque psoriasis are managed satisfactorily on etanercept monotherapy, a proportion may require a modified or alternative treatment regimen (eg, to handle flares or loss of effect) at some point during their chronic management. Despite the clinical need, no published data from randomized controlled studies are currently available that demonstrate efficacy and safety of combined etanercept-based regimens in patients with plaque psoriasis.
The addition of an as-needed topical medication to the step-down dose of etanercept 50 mg once weekly administered after the initial 12 week period of 50 mg twice weekly may be a potential option for patients who may require adjunctive therapy. This study aimed to provide data on this treatment option by estimating the difference in mean percent change in Psoriasis Area and Severity Index (PASI) scores between step-down etanercept 50 mg once weekly supplemented with as-needed topical medication and continuous treatment with etanercept 50 mg twice weekly.
Eligible patients will be enrolled in the study and will receive etanercept 50 mg twice weekly for 12 weeks. After 12 weeks of etanercept treatment, participants will be randomized in a 1:1 ratio to 1 of 2 treatment groups.
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
- Single (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
- •Has had stable moderate to severe plaque psoriasis for at least 6 months (eg, no morphology changes or significant flares of disease activity in the opinion of the investigator).
- •Has a body surface area (BSA) involvement ≥ 10% and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline.
- •Is a candidate for systemic therapy or phototherapy in the opinion of the investigator.
- •Other inclusion criteria may apply.
排除标准
- •Has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
- •Has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept on psoriasis.
- •Diagnosed with medication-induced or medication-exacerbated psoriasis.
- •Significant concurrent medical conditions.
- •Has any active localized infection; requiring local intervention or chronic or localized infections.
- •Other exclusion criteria may apply.
研究组 & 干预措施
Etanercept 50 mg QW + Topical
Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept once weekly plus as needed topical agents.
干预措施: etanercept (Biological)
Etanercept 50 mg BIW
Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept twice weekly for 12 weeks.
干预措施: etanercept (Biological)
Etanercept 50 mg QW + Topical
Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg etanercept once weekly plus as needed topical agents.
干预措施: Topical agents (Drug)
结局指标
主要结局
Percent Change in Psoriasis Area and Severity Index (PASI) From Week 12 to Week 24
时间窗: Week 12 and Week 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 Week 12 to Week 24 is presented as a percentage of the Week 12 value: Week 12 value - Week 24 value / Week 12 value \* 100 so that a positive change indicates improvement. Change was adjusted for treatment using a mixed model.
次要结局
- Percentage of Participants With a PASI 90 Response(Baseline and Weeks 12, 16, 20 and 24)
- Percent Change in PASI From Week 12 to Weeks 16 and 20(Week 12, Week 16 and Week 20)
- Percent Change in PASI From Baseline to Weeks 12, 16, 20, and 24(Baseline and Weeks 12, 16, 20, and 24)
- Percentage of Participants With a PASI 50 Response(Baseline and Weeks 12, 16, 20 and 24)
- Percentage of Participants With a PASI 75 Response(Baseline and Weeks 12, 16, 20 and 24)
- Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)(Weeks 12, 16, 20, and 24)
- Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Baseline to Weeks 12, 16, 20, and 24(Baseline and Weeks 12, 16, 20, and 24)
- Change From Baseline to Weeks 12 and 24 in Dermatology Quality of Life Index (DQLI) Total Score(Baseline and Week 12 and Week 24)
- Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Baseline to Weeks 12 and 24(Baseline and Weeks 12 and 24)
- Health Resource Utilization: Number of Participants With Visits to a Healthcare Provider(Baseline and 24 weeks)
- Health Resource Utilization: Number of Participants With Home Healthcare Visits(Baseline and 24 weeks)
- Health Resource Utilization: Productivity While Working(Baseline and 24 weeks)
- Health Resource Utilization: Number of Participants With Missed Hours From Work(Baseline and 24 weeks)
- Health Resource Utilization: Ability to Perform Daily Activities(Baseline and 24 weeks)
- Number of Participants With Adverse Events(32 weeks)
- Percent Change in the Percentage of Body Surface Area (BSA) Involvement From Week 12 to Weeks 16, 20, and 24(Weeks 12, 16, 20, and 24)
- Change From Week 12 to Week 24 in Dermatology Quality of Life Index (DQLI) Total Score(Week 12 and Week 24)
- Change in Treatment Satisfaction Questionnaire for Medications (TSQM) Scores From Week 12 to Week 24(Week 12 and Week 24)
- Health Resource Utilization: Employment Status(Baseline and 24 weeks)
- Health Resource Utilization: Number of Participants Requiring Paid Help With Chores(Baseline and 24 weeks)
- Health Resource Utilization: Number of Participants Who Needed Friend or Family Care(Baseline and 24 weeks)
- Health Resource Utilization: Out of Pocket Expenses(Baseline and 24 weeks)