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    Summary
    EudraCT Number:2018-004587-61
    Sponsor's Protocol Code Number:NL67752.078.18
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-004587-61
    A.3Full title of the trial
    Deep profiling of lipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab
    Profileren van lipidenveranderingen in patienten met actieve colitis ulcerosa behandeled met tofacitinib of infliximab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Characterization of lipid changes in patients with ulcerative colitis treated with tofactinib or infliximab
    Karakteriseren van veranderingen die optreden in vetten bij patiënten met colitis ulcerosa tijdens de behandeling met tofacitinib of infliximab
    A.3.2Name or abbreviated title of the trial where available
    LIPID
    LIPID
    A.4.1Sponsor's protocol code numberNL67752.078.18
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorErasmus Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportErasmus Medical Center
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportPfizer
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus Medical Center
    B.5.2Functional name of contact pointCoordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressDr. Molenwaterplein
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015GD
    B.5.3.4CountryNetherlands
    B.5.6E-mailj.sleutjes@erasmusmc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xeljanz
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTofacitinib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOFACITINIB
    D.3.9.1CAS number 477600-75-2
    D.3.9.4EV Substance CodeSUB33104
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Inflectra
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameInfliximab
    D.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative colitis
    Colitis ulcerosa
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory bowel disease of the large intestine and rectum
    Chronische ontstekingsziekte van de dikke darm en endeldarm
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess changes in HDL-C and LDL-C concentrations in patients with active ulcerative colitis following tofacitinib of infliximab induction therapy.
    Beoordelen van veranderingen in HDL-C en LDL-C concentraties in patienten met actieve colitis ulcerosa behandeld met tofacitinib of infliximab inductietherapie.
    E.2.2Secondary objectives of the trial
    - 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)
    - Veranderingen in totaal cholesterol, triglyceriden, Apo-AI, Apo-B en Lp(a) na inductietherapie
    - Veranderingen in het totale lipidenprofiel na onderhoudstherapie
    - Verschillen in lipiden veranderingen tussen beide therapieën
    - Correlatie tussen lipidenveranderingen en inflammatoire status
    - Verschuivingen in densiteit van lipoproteinen, de subfracties en veranderingen in compositie en functie
    - Therapie effect op de compositie van HDL2 en HDL3 en de functie waaronder anti-inflammatoir
    - Therapie effect op cholesterolhomeostase (cholesterolabsorptie, -synthese, gaalzuursynthese en oxysterols)
    - Mechanismen onderliggend aan geobserveerde veranderingen in lipoproteinen, met focus op cholesterolmetabolisme, inflammatie, insulineresistentie en galzuren
    - Effectiviteit van tofacitinib en infliximab kijkend naar klinische, biochemische en endoscopische respons
    - Veiligheid van tofacitinib en infliximab gemeten middels bijwerkingen
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    - Leeftijd 18 jaar en ouder
    - Diagnose colitis ulcerosa minimaal 3 maanden geleden gesteld
    - Matig tot ernstige ziekteactiviteit gedefinieerd als SCCAI score van gelijk of meer dan 5 en fecaal calprotectine van meer dan 250 ug/g
    - Refractaire ziekte of intolerantie voor 5-ASA of thiopurines
    - BMI 20-35 kg/m2
    E.4Principal 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
    - Afwezigheid ondertekend informed consent
    - Actieve of huidige infectie
    - Huidige behandeling met biologicals, eerdere behandeling met biologicals zonder respons (met name infliximab zelf) (als patienten wel ooit infliximab gehad hebben met respons en minimaal 12 weken gestopt, dan akkoord met deelname studie)
    - Gelijktijdige behandeling met corticosteroiden (behalve lokale budesonide in afbouw), lipiden regulerende middelen, supplementen van invloed op cholesterolmetabolisme
    - Zwangerschap of lactactie
    - Chronische ziekten zoals diabetes, hypo- of hyperthyreoidie, leverfalen, nierfalen, hyperlipidemie (totaal cholesterol >6.2 mmol/L en triglyceriden >5.0 mmol/L), hypoalbuminemie, cardiopulmonale ziekte, maligniteit, immuundeficientie, psychiatrische ziekte
    E.5 End points
    E.5.1Primary end point(s)
    Changes in HDL-C and LDL-C concentrations in patients with active ulcerative colitis treated with tofacitinib and infliximab induction therapy
    Veranderingen in HDL-cholesterol en LDL-cholesterol na tofacitinib of infliximab inductietherapie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 weken
    E.5.2Secondary 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)
    - Veranderingen in totaal cholesterol, triglyceriden, Apo-A1, Apo-B en Lp(a) na inductietherapie
    - Veranderingen in totale lipidenprofiel na onderhoudstherapie
    - Verschil in veranderingen in lipidenprofiel na tofacitinib en infliximab behandeling
    - Correlatie tussen veranderingen in lipiden en inflammatoire status
    - Shifts in densiteit van lipoproteinen en de subfracties leidend tot veranderingen in compositie en functie
    - Invloed van therapie op HDL2 en HDL3-compositie en -functie
    - Effect van behandeling op cholesterol homeostase waaronder cholesterol absorptie, cholesterol synthese, galzuur synthese en de formatie en rol van oxysterol
    - Mechanismen die ten grondslag liggen aan veranderingen in lipoproteinen, met focus op cholesterol metabolisme, inflammatie, insuline resistentie en galzuren
    - Effectiviteit van tofacitinib en infliximab kijken naar klinische, biochemische en endoscopische respons
    - Veiligheid van tofacitinib en infliximab gemeten middels bijwerkingen
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 weken
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    If treatment with tofacitinib or infliximab is effective and without intolerance, patients can potentially continu current treatment (up to treating physician).
    Als de behandeling met tofacitinib of infliximab effectief is gebleken zonder tekenen van intolerantie, kan de patient potentieel door met de therapie (dit is aan de behandelend arts).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
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