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

Phase 4

Completed

• Conditions: inflammatory bowel disease; ulcerative colitis; 10017969; 10003816

• Registration Number: NL-OMON55536
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes in HDL-C and LDL-C concentrations in patients with active ulcerative<br /><br>colitis treated with tofacitinib and infliximab induction therapy</p><br>