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    Summary
    EudraCT Number:2011-001332-29
    Sponsor's Protocol Code Number:IFX2.0
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-11-07
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-001332-29
    A.3Full title of the trial
    Pharmacokinetics of Infliximab
    Pharmakokinetic von Infliximab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The degradation and elimination of Infliximab
    Die Elimination und der Abbau von Infliximab
    A.4.1Sponsor's protocol code numberIFX2.0
    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 SponsorUniversitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie
    B.1.3.4CountryAustria
    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 supportUniversitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie
    B.5.2Functional name of contact pointWorkgroup for IBD
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.4CountryAustria
    B.5.4Telephone number00431404006245
    B.5.5Fax number00431404004735
    B.5.6E-mailalexander.eser@meduniwien.ac.at
    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 Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor B.V. Einsteinweg 101 2333 CB Leiden Niederlande
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRemicade
    D.3.4Pharmaceutical form Powder for solution for injection/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.3.9.3Other descriptive nameRemicade
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease)
    chronisch entzündliche Darmerkrankungen (Colitis Ulcerosa, Morbus Crohn)
    E.1.1.1Medical condition in easily understood language
    chronic inflammatory bowel disease
    chronisch entzündliche Darmerkrankungen
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 pharmacokinetics of Infliximab in routinely treated patients with inflammatory bowel disease (Crohn's disease, Ulcerative Colitis)
    Ziel ist es, die Pharmakokinetic von Infliximab bei routinemäßig behandelten Patienten mit chronisch entzündlichen Darmerkrankungen (Morbus Crohn, Colitis ulcerosa) zu analysieren.
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with established diagnosis of Crohn’s disease or ulcerative colitis by standard criteria for at least 3 months between the age of 19 to 75. Males and females.
    2. Able and willing to sign informed consent
    3. For maintenance cohort: Patients with maintenance Infliximab therapy after having received week 0, 2 and 6 infusions. Earliest possible measurement for trough level being Week 14 (immediately prior to 4th infusion), earliest possible week 4 serum infliximab level measurement at infusion week 10.
    4. For infliximab starter cohort: Patients planned for IFX induction and maintenance therapy according to current guidelines without prior exposition to IFX.
    1. Patienten mit vorbekannter Diagnose von Morbus Crohn oder Colitis ulcerosa, die seit mindestens 3 Monaten besteht, im Alter von 19 bis 75 Jahren. Männer und Frauen.
    2. In der Lage und willens einen Einverständnisbogen zu unterschreiben.
    3. Für Kohorte mit Erhaltungstherapie: Patienten mit Erhaltungstherapie von Infliximab nach erfolgreicher Induktionstherapie mit Infusionen zu Woche 0, 2 und 6. Frühester Messpunkt für den Talspiegel ist Woche 14 (unmittelbar vor der 4. Infusion), frühester Woche 4 Infliximab-Spiegel zur Woche 10.
    4. Für Infliximab Starter-Kohorte: Patienten, bei denen eine Therapie mit Infliximab gemäß gültigen Richtlinen mit Induktions- und Erhlatungstherapie geplant ist, die bisher noch nie Infliximab erhalten haben.
    E.4Principal exclusion criteria
    1. History of malignancy, lymphoproliferativen disorders or untreated or unsuccessfully treated cutaneous squamous cell or basal cell carcinoma or carcinoma-in-situ of the cervix.
    2. Active or untreated latent tuberculosis, as diagnosed by the current screening recommendations
    3. Severe infections, sepsis, abscess or opportunistic infections
    4. Subjects with an oostomy or ileoanal pouch
    5. Signs and symptoms of intestinal obstruction, clinically or indicated by imaging (praestenotic dilatation, significant prolongation of transition time, ileus signs)
    6. Impending or planned surgery for condition under study
    7. Heart failure NYHA class 3 and 4
    8. Severe unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological or renal disease
    9. Pregnacy, planning conception or currently breast feeding
    10. Investigational agents within 5 halfe lives prior to entry or within the past 30 days
    11. Sigificant drug or alcohol abusus, current or past, or other mental condition impairing study participation
    1. Malignome, lymphoproliverative Erkrankungen, unbehandelte oder nicht erfolgreich behandelte kutane Plattenepithelkarzinome oder Basaliome oder in-situ Karzinome der Cervix uteri in der Vorgeschichte.
    2. Aktive oder unbehandelte latente Tuberkulose, nachgewiesen gemäß den derzeit gültigen Kriterien
    3. Schwere Infektionen, Sepsis, Abszesse oder opportunistische Infektionen
    4. Patienten mit Stoma oder ileoanalem Pouch
    5. Zeichen oder Symptome einer intestinalen Verstopfung, klinisch oder durch Bildgebung (prästenotische Dilatation, signifikante Verlängerung der Transitzeit, Zeichen eines Ileus)
    6. Bevorstehende oder geplante Operation für M. Crohn oder Colitis ulcerosa
    7. Herzinsuffizienz nach NYHA Klasse 3 oder 4
    8. Schwere instabile hepatische, gastrointestinale, kardiovaskuläre, respiratorische, neurologische psychiatrische, hämatologische oder renale Erkrankung
    9. bestehende oder geplante Schwangerschaft oder derzeitiges Stillen
    10. Erhalt einer Studienmedikation innerhalb von 5 Halbwertszeiten vor Beginn dieser Studie oder innerhalb der letzten 30 Tage
    11. Wesentlicher Drogen- oder Alkoholmissbrauch, derzeit oder in der Vergangenheit, sowie andere eine Studienteilnahme beeinträchtigende Zustände
    E.5 End points
    E.5.1Primary end point(s)
    Difference of measured serum infliximab levels at week 4 during maintenance infusion interval and immediately prior to infusion (trough level) versus predicted levels, as calculated by prediction model (see Methods).
    Unterschied der gemessenen Serum Infliximab Spiegel zu Woche 4 und direkt vor einer Infusion (Talspiegel) während einer Erhaltungstherapie verglichen mit prognostizierten Spiegel aus einem Vorhersagemodell (siehe Methoden).
    E.5.1.1Timepoint(s) of evaluation of this end point
    not applicable
    Nicht zutreffend
    E.5.2Secondary end point(s)
    • Rate of mucosal healing in patients with trough levels above 3 μg/ml during maintenance versus trough levels below 3 μg/ml
    • Rate of steroid free clinical remission in patients with trough levels above 3 μg/ml during maintenance
    • Fecal Calprotectin, CRP, CD64, IL-6 in patients with rapid elimination kinetics vs. slow elimination at the time points as specified below
    • Rate of primary remission in CD patients
    • Rate of primary response in CD patients
    • Rate of primary remission in UC patients
    • Rate of primary response in UC patients
    • Comparison pharmacokinetic properties (c-max, terminal half-life, AUC, clearance) of patients with primary response vs. primary non-responders and patients in remission
    • Rate of disease worsening
    • Comparison of pk properties at time of disease worsening (prior infusion interval while responding versus current infusion interval)
    • Rate an mukosaler Heilung bei Patienten mit Talspiegeln über 3 µg/ml während Erhaltungstherapie verglichen mit Talspiegeln unter 3 µg/ml
    • Rate an steroidfreier klinischer Remission bei Patienten mit Talspiegeln über 3 µg/ml unter Erhaltungstherapie.
    • fäkales Calprotectin, CRP, CD64, IL-6 bei Patienten mit rascher eliminationskinetik verglichen mit langsamer Elimination zu den festgelegten Zeitpunkten
    • Rate an primärer Remission bei Patienten mit M. Crohn
    • Rate an primären Ansprechen bei Patienten mit M. Crohn
    • Rate an primärer Remission bei Patienten mit Colitis ulcerosa
    • Ratan primären Ansprechen bei Patienten mit Colitis ulcerosa
    • Vergleich pharmakokinetischer Parameter (c-max, terminal half-life, AUC, clearance) bei Patienten mit primären Ansprechen verglichen mit primären Nichtansprechen und Patienten in Remission
    • Rate an Verschlechterung der Krankheitsaktivität
    • Vergleich von pharmakokinetischen Parametern zum Zeitpunkt einer Verschlechterung der Krankheitsaktivität (vorheriges Infusionsintervall mit Ansprechen verglichen mit jetztigem Infusionsintervall
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    Nicht zutreffend.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Letzter Besuch des letzten Patienten
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-11-07. Yes
    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 state200
    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)
    none
    keine
    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 Decision2013-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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