NL-OMON55536已完成4 期
Deep profiling of lipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab - LIPID study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Aged 18 years or older
- •- Previous diagnosis with ulcerative colitis of at least 3 months
- •- Moderately to severe disease defined as SCCAI equal or more than 5 and fecal
- •calprotectine more than 250 ug/g
- •- Refractory disease or intolerance for 5-ASA, thiopurines and/or biologicals
- •- Body mass index of 20-35 kg/m2
排除标准
- •- Absence of written informed consent
- •- Active or current infection
- •- Current treatment with biologicals (wash-out 8 weeks)
- •- Concomitant medication use to be named corticosteroids (except for locally
- •administered or low dose systemic corticosteroids, e.g. prednisone <20mg and
- •budesonide <9mg), lipidregulating agents, supplements with involved in
- •cholesterol metabolism
- •- Pregnancy and lactation
- •- Concomitant disease to be named diabetes, hypo- or hyperthyroeidism, liver or
- •renal failure, adrenal failure, hyperlipidemia, hypoalbuminemia,
- •cardiopulmonary disease, malignancy, immunodeficiency, psychiatric illnesses
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