Deep profiling of lipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab - LIPID

Erasmus Medical Center0 个研究点目标入组 40 人开始时间: 2019年5月13日最近更新: 2019年12月16日

试验速览

暂无简介。

•- 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 or thiopurines
•- Body mass index of 20-35 kg/m2
•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 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- Absence of written informed consent
•- Active or current infection
•- Current treatment with biologicals or previous treatment without response (especially with infliximab) (if patient is infliximab experienced, with previous clinical respons and stopped for at least 12 weeks, inclusion is allowed)
•- Concomitant medication use to be named corticosteroids (except for locally administered budesonide down tapering), 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 (total cholesterol >6.2 mmol/L and triglycerides >5.0 mmol/L), hypoalbuminemia, cardiopulmonary disease, malignancy, immunodeficiency, psychiatric illnesses

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