Oral Chinese Herbal Medicine Formula (Gu Ben Hua Yu Fang) Concurrent With Secukinumab for Severe Plaque Psoriasis
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Median time to relapse
研究概览
简要总结
The aim of this study is to determine whether oral Chinese herbal medicine in combination secukinumab is effective and safe in the treatment of severe psoriasis.
详细描述
The aim of this study is to determine whether oral Chinese herbal medicine in combination with secukinumab is effective and safe in the treatment of severe psoriasis. Eligible participants will be treated with oral Chinese herbal medicine and secukinumab concurrently. No controlled group will be set up in this trial. The primary outcome is time to relapse. Secondary outcomes include Psoriasis Area and Severity Index (PASI) 75/90, PASI score reduction rate, physician's global assessment (PGA) score, body surface area (BSA) score, visual analogue scale (VAS) score, dermatology life quality index (QLQI) and Skindex 16.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Psoriasis Area and Severity Index (PASI) score≥10
- •Meet the requirement of using secukinumab; without the history of inflammatory bowel disease (IBD)
- •Written/signed informed consent
排除标准
- •Unsuitable for the treatment of secukinumab
研究组 & 干预措施
Chinese herbal medicine in combination with secukinumab
Oral Chinese herbal medicine (Gu Ben Hua Yu Fang decoction) and secukinumab will be used concurrently. The treatment duration for both secukinumab and oral Chinese herbal medicine is up to 16 weeks. Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg). Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice a day. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection.
干预措施: Gu Ben Hua Yu Fang decoction (Chinese herbal medicine) (Drug)
Chinese herbal medicine in combination with secukinumab
Oral Chinese herbal medicine (Gu Ben Hua Yu Fang decoction) and secukinumab will be used concurrently. The treatment duration for both secukinumab and oral Chinese herbal medicine is up to 16 weeks. Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg). Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice a day. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection.
干预措施: Secukinumab Auto-Injector [Cosentyx] (Drug)
结局指标
主要结局
Median time to relapse
时间窗: Through study completion, an average of 1 year
Median time to relapse is a time interval. The time interval will be recorded between the end of treatment and the occurrence of relapse. Relapse was defined as loss of \> 50% of maximum Psoriasis Area and Severity Index (PASI) improvement compared with pretreatment baseline.
次要结局
- Psoriasis Area and Severity Index (PASI) score(Assessment will be conducted at week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year)
- PASI-75(16 weeks after treatment)
- PASI-90(16 weeks after treatment)
- Physician's global assessment (PGA) score(Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.)
- Pruritus Scores on the Visual Analogue Scale(Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.)
- patients' attitudes, expectation and experience(Interview will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).)
- BSA(Assessment will be conducted on week 0, 1, 2, 3, 4, and every four weeks throughout the remaining period the this trial, an average of 1 year.)
- Dermatology Life Quality Index (DLQI)(Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).)
- Skindex16(Assessment will be conducted on week 0, 16 and the end of study completion (once relapse occurs, an average of 1 year).)
研究者
Chuanjian Lu
Professor
Guangdong Provincial Hospital of Traditional Chinese Medicine