A Multicenter Open-Label Continuation Study of the Long-term Safety and Efficacy of Adalimumab (D2E7) in Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 64
- 主要终点
- Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
研究概览
简要总结
To evaluate efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with psoriasis
详细描述
This was a continuation trial of adalimumab in participants with moderate to severe chronic plaque psoriasis who had completed Study M04-688 (NCT00338754), a 24-week, double-blind, placebo-controlled study. This study was an open-label extension study that continued until the approval of adalimumab for the treatment of psoriasis in Japan.
During Study M04-688 (NCT00338754), participants received 24 weeks of treatment with adalimumab 40 mg every other week (eow) with or without a loading dose, adalimumab 80 mg eow, or placebo.
At the start of this study, participants who had received adalimumab 40 mg eow or adalimumab 80 mg eow in Study M04-688 (NCT00338754) continued on the same treatment regimen. Participants who had received placebo during Study M04-688 (NCT00338754) were re-randomized at the start of this study to receive adalimumab 40 mg eow or adalimumab 80 mg eow.
Participants in the adalimumab 40 mg eow treatment group who failed to achieve a PASI50 response (>= 50% reduction in the Psoriasis Area and Severity Index score from Baseline of Study M04-688 [NCT00338754]) at or anytime after Week 12 of this study were given the option to increase their dose to adalimumab 80 mg eow. Once the dose was escalated, there was no option to de-escalate dosing back to 40 mg eow. Participants who failed to achieve PASI50 responses while receiving adalimumab 80 mg eow may have been discontinued from the study after evaluating the risk/benefit of further treatment with adalimumab.
At Week 28 of this study, it was mandatory for all participants who started the study in the adalimumab 80 mg eow treatment group (i.e., not including the dose escalators described above) to reduce their dose to adalimumab 40 mg eow, regardless of their response status. Following this mandatory dose reduction, if these participants failed to achieve or maintain PASI50 response, they were permitted to escalate their dose to adalimumab 80 mg eow. There was no option to de-escalate dosing back to 40 mg eow following dose escalation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who completed Study M04-688 (NCT00338754)
排除标准
- •Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study
研究组 & 干预措施
Adalimumab 80 mg every other week
干预措施: adalimumab (Biological)
Adalimumab 40 mg every other week
干预措施: adalimumab (Biological)
结局指标
主要结局
Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
时间窗: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
次要结局
- Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)(Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab)
- Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)(Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab)