World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 16 December 2019
Main ID:  EUCTR2018-004587-61-NL
Date of registration: 13/05/2019
Prospective Registration: No
Primary sponsor: Erasmus Medical Center
Public title: Characterization of lipid changes in patients with ulcerative colitis treated with tofactinib or infliximab
Scientific title: Deep profiling of lipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab - LIPID
Date of first enrolment: 23/04/2019
Target sample size: 40
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-004587-61
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Netherlands
Contacts
Name: Coordinating investigator    
Address:  Dr. Molenwaterplein 3015GD Rotterdam Netherlands
Telephone:
Email: j.sleutjes@erasmusmc.nl
Affiliation:  Erasmus Medical Center
Name: Coordinating investigator    
Address:  Dr. Molenwaterplein 3015GD Rotterdam Netherlands
Telephone:
Email: j.sleutjes@erasmusmc.nl
Affiliation:  Erasmus Medical Center
Key inclusion & exclusion criteria
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 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

Exclusion criteria:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Ulcerative colitis
Intervention(s)

Trade Name: Xeljanz
Product Name: Tofacitinib
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TOFACITINIB
CAS Number: 477600-75-2

Trade Name: Inflectra
Product Name: Infliximab
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3

Primary Outcome(s)

Secondary Objective: - Changes in total cholesterol, triglycerides, Apo-AI, Apo-B and lipoprotein(a) (Lp(a)) after induction therapy
- Changes in total lipid profile after maintenance therapy
- Difference in changes in lipid profile between tofacitinib and infliximab therapy
- Correlation between lipid changes and inflammatory status
- Shifts in density of the lipoproteins, their subfractions, the alterations in composition and functioning
- Effect on HDL2 and HDL3 composition and its functioning including anti-inflammatory
- Effect on cholesterol homeostasis including cholesterol absorption, cholesterol synthesis, bile acid synthesis and the formation and role of oxysterol
- Mechanisms underlying the observed changes in lipoproteins, focussing on cholesterol metabolism, inflammation, insulin resistance and bile acids
- Effectiveness of both therapies with regard to clinical, biochemical and endoscopic response
- Safety of tofacitinib and infliximab measured by adverse events (AEs)
Main Objective: To assess changes in HDL-C and LDL-C concentrations in patients with active ulcerative colitis following tofacitinib of infliximab induction therapy.
Primary end point(s): Changes in HDL-C and LDL-C concentrations in patients with active ulcerative colitis treated with tofacitinib and infliximab induction therapy
Timepoint(s) of evaluation of this end point: 8 weeks
Secondary Outcome(s)

Secondary end point(s): - Changes in total cholesterol, triglycerides, Apo-AI, Apo-B and lipoprotein(a) (Lp(a)) following induction therapy
- Changes in total lipid profile following maintenance therapy
- Difference in change in lipid profile between both therapies
- Correlation between lipid changes and inflammatory status
- Shifts in density of the lipoproteins or their subfractions and alterations in composition and functioning
- Effect on HDL2 and HDL3 composition and functioning including anti-inflammatory function
- Effect on cholesterol homeostasis including cholesterol absorption, cholesterol synthesis, bile acid synthesis and the formation and role of oxysterol
- Mechanisms underlying the observed changes in lipoproteins, focussing on cholesterol metabolism, inflammation, insulin resistance and bile acids
- Effectiveness of tofacitinib and infliximab with regard to clinical, biochemical and endoscopic response
- Safety of tofacitinib and infliximab measured by adverse events (AEs)
Timepoint(s) of evaluation of this end point: 52 weeks
Secondary ID(s)
NL67752.078.18
Source(s) of Monetary Support
Erasmus Medical Center
Pfizer
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history