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

Erasmus Medical Center0 sites40 target enrollmentMay 13, 2019

Overview

No summary available.

Registry

who.int

Start Date

May 13, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•\- 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

•\- 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