Ulcerative colitis Lipids Tofacitinib Infliximab
Conditions
Interventions
Randomization in a 1:1 to either:
- tofacitinib arm: induction therapy 10mg oral tablets twice daily during 8 weeks and maintenance therapy 5mg tablets twice daily until week 52
- infliximab arm: in
Sponsors
Erasmus Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - aged 18 years or older - previous diagnosis with ulcerative colitis (UC) of at least 3 months - at least moderately active UC defined as SCCAI-score ¡Ý5 or FCP >150 ug/g - 5-ASA or thiopurine refractory or intolerant disease - BMI 20-35 kg/m2
Exclusion criteria
Exclusion criteria: - absence written informed consent - imminent need for in-hospital treatment - concomitant use of oral of intravenous corticosteroids (except locally administered budesonide down tapering) - current or previous treatment with a biological agents (except history of infliximab use with good clinical response, discontinued at least 12 weeks prior to randomization) - concomitant use of lipid-regulating agents, ormonal forms of contraception, isotretinoin, supplements with plant sterols, stanols or cholestin - current or previous treatment with investigational drugs - pregnancy or lactation - concomitant disease or abnormalities (pancytopenia, kidney or liver failure, acute/latent/inadequately treated infection, hyperlipidemia, hypoalbuminemia, cardiopulmonary disease, endocrine disease) - other signficant illnesses (e.g. malignancy, immunodeficiency syndromes, psychiatric illness) - impossibility to measure outcomes (plannen relocation, language issues, short life expectancy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HDL- and LDL-cholesterol concentrations after tofacitinib and infliximab induction therapy of 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in total cholesterol, triglycerides, apo-A1, apo-B, Lp(a) after induction therapy - Changes in total cholesterol, HDL, LDL, triglycerides, apo-A1, apo-B, Lp(a) after maintenance therapy - Correlation between lipid changes and inflammatory status - Shifts in density of lipoproteins and their subfractions with alterations in their composition and functioning - Effect of treatment on HDL2 and HDL3 composition and functioning (including anti-inflammatory function) - Effect of treatment on cholesterol homeostasis (cholesterol absorption, synthesis, bile acid synthesis and oxysterol formation) - Mechanisms underlying changes in lipoproteins focussing on cholesterol metabolism, inflammation, insulin resistance and bile acids - Difference in change in lipid profile between tofacitinib and infliximab treatment - Difference in treatment efficacy with regard to clinical, biochemical and endoscopic response - Difference in safety profile measured by adverse events (AEs) | — |
Outcome results
None listed