DRKS00022104已完成3 期
Influence of psychological factors on the response to therapy with Secukinumab in psoriasis patients on the subjective and objective level - PSOPSYCH
niversitätsklinikum Essen (AöR)Allgemeine Poliklinik, PsoriasisKlinik für Dermatologie, Venerologie und Allergologie0 个研究点目标入组 120 人开始时间: 2020年6月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •(1) subject has had diagnosis of moderate-to-severe chronic plaque psoriasis for at least 6 months; (2) Psoriasis Area and Severity Index (PASI) >12 and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater; (3) patient is a candidate for systemic therapy (this is defined as a patient having moderate-to-severe chronic plaque psoriasis that is inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy); (4) women must not be pregnant and if of childbearing potential, must have a negative serum pregnancy test before entering the study; (5) women of childbearing potential must agree to use a highly effective method of contraception throughout the therapy.
排除标准
- •(1) age <18 years; (2) forms of psoriasis other than chronic plaque (e.g, pustular, erythrodermic, guttate or drug-induced) psoriasis; (3) existing contraindication to therapy with secukinumab according to the summary of product characteristics like history of hypersensitivity to secukinumab or its excipients or to drugs of similar chemical classes or clinically relevant (chronic or acute) infections, e.g. untreated (latent) tuberculosis or HIV infection; (4) significant medical problems, which in the opinion of the investigator, significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving therapy with secukinumab; (5) history of, respectively active, inflammatory bowel disease (IBD); (6) administration of live vaccines <6 weeks before first injection of secukinumab; (7) any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the protocol or completing the study per protocol; (8) previous exposure to secukinumab; (9) ongoing use of systemic anti-psoriatic treatments (concomitant topical treatment is allowed); (10) history or evidence of ongoing alcohol or drug abuse, within the last six months before start of the study; (11) subject is lacking capacity to consent.
研究者
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