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    Summary
    EudraCT Number:2011-002061-38
    Sponsor's Protocol Code Number:S53299
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-08
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-002061-38
    A.3Full title of the trial
    A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treating patients with infliximab based on their trough levels
    A.3.2Name or abbreviated title of the trial where available
    TAXIT
    A.4.1Sponsor's protocol code numberS53299
    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 SponsorKatholieke Universiteit Leuven
    B.1.3.4CountryBelgium
    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 supportKatholieke Universiteit Leuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKatholieke Universiteit Leuven
    B.5.2Functional name of contact pointLab. for Pharmaceutical Biology
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49-box 824
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3216323434
    B.5.5Fax number3216323460
    B.5.6E-mailniels.vandecasteele@pharm.kuleuven.be
    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 holderJanssen Biologics B.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.2Product code Remicade
    D.3.4Pharmaceutical form Powder for concentrate 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.3.10 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 Yes
    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
    2) Crohn's disease and ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory bowel diseases
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We hypothesize that in patients suffering from Crohn’s disease (CD) or ulcerative colitis (UC) under anti-tumor necrosis factor-a (anti-TNF) treatment, sustained good anti-TNF trough levels are associated with a better long term outcome (better response and remission rates, more mucosal healing and less loss of response) and will lead to a better quality of life, less disease-related surgeries and less hospitalizations. We will adapt the infliximab treatment regimen of each patient in the test group in such a way that trough levels are kept in a window between 3 and 7 µg/ml. The main objective of this study is to assess the clinical outcome of individually optimised therapy based on trough levels in the follow-up of the patients during 12 months, compared to a control group in which the treatment regimen is adapted according to standard clinical practice (i.e. clinical and biological monitoring).
    E.2.2Secondary objectives of the trial
    Compare the proportion of patients with an infliximab trough level between 3-7µg/ml in both treatment groups after 12 months.
    Compare the total infliximab dose given in both treatment groups after 12 months.
    Compare the total cost of treatment in both treatment groups after 12 months.
    Compare the proportion of patients needing switch to adalimumab (Humira®) during follow up.
    Compare the number of infusion reactions in both treatment arms after 12 months.
    Compare the number of treatment adaptations in both treatment groups after 12 months.
    Compare the median biologic activity (CRP-levels) in both treatment groups after 12 months.
    Compare the number of disease flares in both treatment groups after 12 months.
    Compare the number of Serious Adverse Events (SAEs) in both treatment groups after 12 months.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Males and females ≥ 18 and ≤ 64 years of age
    - Diagnosis of CD or UC confirmed by endoscopy and histology and in stable clinical remission
    - Signed informed consent
    - On anti-TNF infliximab maintenance therapy for at least 14 consecutive weeks
    E.4Principal exclusion criteria
    - Not willing to participate in study or not willing to sign inform consent
    - Patients included in placebo-controlled trials
    - Patients not in stable remission upon entry into the study (designated by symptoms, CRP>5mg/ml and endoscopic lesions)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients in clinical and biological (CRP<5mg/l) remission in both treatment groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At month 12.
    E.5.2Secondary end point(s)
    The proportion of patients with an infliximab trough level between 3-7µg/ml in both treatment groups.
    The total infliximab dose given in both treatment groups.
    The total cost of treatment in both treatment groups.
    The proportion of patients needing switch to adalimumab (Humira®) during follow up.
    The number of infusion reactions in both treatment arms.
    The number of treatment adaptations in both treatment groups.
    The median biologic activity (CRP-levels) in both treatment groups.
    The number of disease flares in both treatment groups.
    The number of Serious Adverse Events (SAEs) in both treatment groups.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At month 12.
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.1.3Single blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    different treatment schedule (control group: according to standard clinical practice)
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 200
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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)
    It is not is different from the expected normal treatment of that condition.
    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 Decision2011-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-01
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