EUCTR2019-004230-42-NL进行中（未招募）1 期
Dose reduction of the new generation biologics (IL17 and IL23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study - BeNeBio study - BeNeBio
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Radboudumc
- 入组人数
- 244
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Plaque psoriasis (primarily)
- •Treatment for 6 months at least with IL23 or IL17 inhibitor in a normal dose (dose advised by the label)
- •PASI (Psoriasis Area and Severity Index) = 5 at inclusion and in previous 6 months (in previous 6 months, it should be clear from the patient record that psoriasis was clear/almost clear if no PASI scores are available).
- •DLQI = 5 at inclusion
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •Another indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication).
- •Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc).
- •Severe comorbidities with short life-expectancy (e.g. metastasized tumour).
- •Presumed inability to follow the study protocol.
研究者
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Dose decrease of biologics for psoriasisAdult Patients diagnosed psoriasis vulgarisMedDRA version: 18.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 18.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 18.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 18.1Level: LLTClassification code 10015581Term: Exacerbation of psoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 18.1Level: LLTClassification code 10037155Term: Psoriasis and similar disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 18.1Level: LLTClassification code 10037156Term: Psoriasis flare-upSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2015-000943-17-NLRadboudumc120