A Study of Dose Optimization of Infliximab in the Treatment of Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 39
- 主要终点
- Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28
研究概览
简要总结
Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.
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
- None
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
- •Subjects must have a diagnosis of moderate to severe plaque-type psoriasis and have had participated in Study P
- •Subjects must have demonstrated an adequate but suboptimal response to infliximab in Study P05319
- •Subjects must be at least 18 years old
- •Subjects must be candidates for phototherapy or systemic treatment for psoriasis.
- •Subjects must not be pregnant and must meet contraceptive requirements
- •Subjects must meet tuberculosis screening criteria
- •Subjects must meet laboratory and medical history screening requirements
排除标准
- •Subjects for whom infliximab or methotrexate is contraindicated or not recommended.
- •Subjects already using certain investigational, biological, or immunosuppressive drugs
- •Subjects with certain comorbid conditions
- •Subjects who currently have or have a history of certain infections
- •Subjects who have recently received live virus or bacterial vaccinations
- •Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
研究组 & 干预措施
IFX q 6 weeks
干预措施: Infliximab (Drug)
IFX + MTX
干预措施: Infliximab and methotrexate (Drug)
结局指标
主要结局
Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28
时间窗: Baseline, Week 28
The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.
次要结局
- Number of Participants With A PASI-90 Response at Week 28(Baseline, Week 28)
- Number of Participants With A PASI-100 Response at Week 28(Baseline, Week 28)
- Change From Baseline in Mean Participant Raw PASI Scores at Week 28(Baseline, Week 28)
- Dermatology Life Quality Index (DLQI) at Week 28(Week 28)
- Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28(Baseline, Week 28)
- Number of Participants With A PASI-50 Response at Week 28(Baseline, Week 28)