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    Summary
    EudraCT Number:2020-004012-10
    Sponsor's Protocol Code Number:MODIFI
    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:2021-04-30
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-004012-10
    A.3Full title of the trial
    Model-informed infliximab dose de-escalation following earlier dose escalation in adult patients with inflammatory bowel diseases
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Model-informed prolonging of the infliximab dosing interval after an earlier shortening of the dosing interval in adult patients with inflammatory bowel diseases
    A.3.2Name or abbreviated title of the trial where available
    MODIFI
    A.4.1Sponsor's protocol code numberMODIFI
    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 SponsorUZ 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 supportUZ Leuven, Department of Gastroenterology and Hepatology
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportKU Leuven, Laboratory for Therapeutic and Diagnostic Antibodies
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Leuven, Campus Gasthuisberg
    B.5.2Functional name of contact pointDienst maag-, darm-, leverziekten
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat, 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3216344225
    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 Inflectra
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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 nameinfliximab
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 diseases
    - Crohn's disease
    - ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    Inflammatory bowel diseases
    - Crohn's disease
    - ulcerative colitis
    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 compare the steroid-free, combined clinical and biological outcome between model-informed infliximab dose de-escalation and standard dose de-escalation in patients with inflammatory bowel diseases.
    E.2.2Secondary objectives of the trial
    - To compare the (evolution of) infliximab exposure
    - To compare the (evolution of) clinical outcome
    - To compare the (evolution of) biological outcome
    - To compare the socio-economic aspects
    - To compare the quality of life
    between model-informed infliximab dose de-escalation and standard dose de-escalation in patients with inflammatory bowel diseases.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The subject is aged 18 to 80 years inclusive.
    - The subject is diagnosed with moderately to severely active ulcerative colitis or Crohn’s disease, confirmed by clinical, endoscopic, histological, and/or imaging criteria.
    - The subject was in maintenance therapy, later lost their response to treatment and subsequently gained steroid-free, clinical and biological remission following infliximab dose escalation (i.e., by increasing the dose and/or shortening the dosing interval) and had an infliximab trough concentration ≥5 mg/L.
    - Adequate contraception in female subjects of reproductive age (oral contraception, intra-uterine device, sterilisation or barrier method).
    E.4Principal exclusion criteria
    - The subject is aged <18 years or >80 years.
    - The subject receives infliximab prophylactically (e.g. in the immediate postoperative setting).
    - The subject has an ostomy or an ileal anal pouch anastomosis.
    - If female subjects, when pregnant (based on a positive serum sample) or lactating or intending to become pregnant or nurse before, during or within 15 weeks after the last dose of study drug; or intending to donate ova during such time period.
    - The subject is participating in another interventional clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients maintaining steroid-free, combined clinical and biological remission during one year after infliximab dose de-escalation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuously during one year after the first infliximab infusion in the trial.
    E.5.2Secondary end point(s)
    - The proportion of patients maintaining (steroid-free), combined clinical and biological remission at
    - The proportion of patients maintaining (steroid-free) clinical remission at
    - The proportion of patients maintaining (steroid-free) clinical remission during
    - The proportion of patients maintaining (steroid-free) biological remission at
    - The infliximab trough concentration at
    - The average infliximab trough concentration during
    - The probability of target attainment for the trough concentration target attainment at
    - The probability of target attainment for the trough concentration target attainment during
    - The model-predicted area under the infliximab concentration-time curve during
    - The infliximab dose at
    - The total infliximab dose during
    - The number of infliximab infusion visits during
    - The direct cost of infliximab therapy at
    - The direct cost to proportion of patients maintaining steroid-free, combined clinical and biological remission ratio at
    one year after infliximab dose de-escalation based on a standard dosing algorithm versus a model-informed dosing algorithm.

    - The total cost (i.e., direct and indirect costs) of infliximab therapy
    - The quality-adjusted life years
    - The total cost to quality-adjusted life year ratio
    before versus after one year dose de-escalation within each patient in the prospective (model-informed dose de-escalation) study arm.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuously during one year after the first infliximab infusion in the trial ("during") or at one year after the first infliximab infusion in the trial ("at").
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    Non-randomized, non-blinded, historically controlled, interventional trial
    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
    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 months6
    E.8.9.1In the Member State concerned days
    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)
    Once the subject has ended the participation in the trial, the treating physician will evaluate the health conditions of the subject. If the subject still responds well to treatment with the trial medication, the subject can be further treated with infliximab according to the last proposed treatment schedule. After the trial has ended for a subject, his/her treatment schedule will not anymore be individually guided.
    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 Decision2021-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
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