Treatment with tofacitinib or infliximab show similar changes in lipid and lipoprotein levels in patients with ulcerative colitis
ID
Bron
Aandoening
Ulcerative colitis
Lipids
Tofacitinib
Infliximab
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Changes in HDL- and LDL-cholesterol concentrations after tofacitinib and infliximab induction therapy of 8 weeks
Achtergrond van het onderzoek
Recently tofacitinib is registered for the treatment of moderate to severe ulcerative colitis. In the tofactinib clinical development program (OCTAVE), mild elevations in serum lipid levels in a proportion of those receiving tofacitinib were described without further side effects. Mild alterations in the lipid profile are also observed in patients with inflammatory bowel disease (IBD) treated with infliximab (IFX). Although an overall increase in total cholesterol and low density lipoprotein cholesterol (LDL-C) is unwanted, an increase in high density lipoprotein cholesterol (HDL-C) as a result of treatment might protect against cardiovascular events. Moreover, these findings are consistent with the previously observed inverse relationship between active inflammation and serum lipid levels in chronic inflammatory disease including rheumatoid arthritis (RA) and psoriatic arthritis (PA). The mechanisms by which the inflammatory process can lead to these lipid changes are not fully understood.
Doel van het onderzoek
Treatment with tofacitinib or infliximab show similar changes in lipid and lipoprotein levels in patients with ulcerative colitis
Onderzoeksopzet
Infliximab: weeks 0, 5, 8, 21, 52
Tofacitinib: weeks 0, 5, 8, 21, 34, 47, 52
Onderzoeksproduct en/of interventie
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: induction therapy with infliximab infusions 5mg/kg on week 0, 2 and 6 and maintenance therapy of infliximab infusions 5/mg/kg every 8 weeks
Additional interventions:
- vena punction for serum sample analyses
- home test for stool sampling
- questionnaires
(- preferably, endoscopy)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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)
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7377 |
| NTR-old | NTR7585 |
| CCMO | NL67752.078.18 |
| OMON | NL-OMON55536 |