A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 7
- 主要终点
- Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650 at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but decreased thereafter.
详细描述
- Patients with plaque psoriasis or psoriatic arthritis:
- Screening Period:
TA-650 at 5 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and week 8 (if efficacy is not judged as decreased or maintained at week 8 of the screening period) , respectively, by intravenous infusion slowly over at least 2 hours. 2. Increased Dose Period:
If efficacy is judged as decreased in the screening period, TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32 in the increased dose period , respectively, as one dose by intravenous infusion slowly over at least 2 hours.
- Patients with pustular psoriasis or psoriatic erythroderma:
TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32, respectively, as one dose by intravenous infusion slowly over at least 2 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have already been diagnosed as having plaque psoriasis, psoriatic arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma.
- •Patients in whom effect of the treatment was confirmed for a certain period after the start of administration of Remicade® at 5 mg/kg at every 8 weeks but decreased thereafter.
排除标准
- •Patients who have guttate psoriasis.
- •Patients who have drug-induced psoriasis
- •Patients who have previously used any other biological products than infliximab.
- •Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of serious infections that need hospitalization.
- •Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of opportunistic infections
- •Female patients who are pregnant, breast-feeding, or possibly pregnant.
研究组 & 干预措施
TA-650
干预措施: TA-650 (Drug)
结局指标
主要结局
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
时间窗: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling \[scale\]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions. When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs). The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.
次要结局
- Psoriasis Area and Severity Index (PASI) Score(Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period)
- Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)(Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period)
- Assessment of Severity (Only for Patients With Pustular Psoriasis)(Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period)
- Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)(Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period)