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    Summary
    EudraCT Number:2015-004618-10
    Sponsor's Protocol Code Number:PACIFIC
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-11-20
    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 number2015-004618-10
    A.3Full title of the trial
    Study of the inter-individual variation of PhArmaCo-kinetics of InFliximab during treatment Induction in patients with Crohn’s disease and Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PhArmaCo-kinetics of InFliximab during treatment Induction
    A.4.1Sponsor's protocol code numberPACIFIC
    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 SponsorCUB- Hopital Erasme
    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 supportBIRD Group
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCUB- Hopital Erasme
    B.5.2Functional name of contact pointLiefferinckx
    B.5.3 Address:
    B.5.3.1Street Address808 route de Lennik
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1070
    B.5.3.4CountryBelgium
    B.5.4Telephone number003225556196
    B.5.5Fax number003225556197
    B.5.6E-mailclaire.liefferinckx@ulb.ac.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 Remsima
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft
    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.3.4Pharmaceutical 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.3.9.3Other descriptive nameRemsima
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 10
    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.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 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.3.4Pharmaceutical 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.3.9.3Other descriptive nameRemicade
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 10
    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.IMP: 3
    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 holderHospira UK Limited
    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.3.4Pharmaceutical 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.3.9.3Other descriptive nameInflectra
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 10
    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
    Patients with Crohn disease or Ulcerative Colitis which need biotherapy (antibody against TNF-a)
    E.1.1.1Medical condition in easily understood language
    Patients with Crohn disease or ulcerative colitis which need biotherapy (antibody against TNF-a)
    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
    Evaluation of the inter-individual variability of the pharmacokinetics of infliximab level and antibodies to infliximab during induction treatment and correlation with clinical response at W14 and W30
    E.2.2Secondary objectives of the trial
    Proportion of patients in steroid-free remission at W10-14 w/o normal CRP and/or fecal calprotectin levels

    Sustained steroid-free clinical response at W30 w/o normal CRP and/or fecal calprotectin levels and mucosal healing

    Sustained steroid-free clinical remission at W30 w/o normal CRP and/or fecal calprotectin levels

    Correlation of patient population in third and fourth quartile of IFX levels during the induction phase (W0-W10) with clinical response or remission, and/or normal CRP and/or normal fecal calprotectin levels at W14 and 30

    Correlation of patient population in third and fourth quartile of IFX levels during the induction phase (W0-W10) with sustained IFX levels > 3 μg/ml at W14 and W30 without need for optimization

    Correlation of patient population in third and fourth quartile of IFX levels during the induction phase (W0-W10) with sustained IFX levels in third and fourth quartile at W14 and W30
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age > 18 years

    Moderate-to-severe CD (HBI≥8) with endoscopically visible ulcers or moderate-to-severe and severe UC (Mayo Score ≥6) and Mayo endoscopic subscore >1 (APPENDIX 1-2-3) (a patient with active disease without CRP can be included)

    Patients must be starting on infliximab (Remicade (MSD) or CT-P13: Remsima (Mundipharma) or Inflectra (Hospira)) in accordance with national reimbursement criteria or a washout period of 8 weeks will be observed before starting any new anti-TNF therapy after vedolizumab and 4 weeks after adalimumab before starting infliximab

    Patients may be naïve to thiopurines or have failed therapy with 1 thiopurine; in which case AZA or 6MP will be either continued or stopped: The dose must remain stable 4 weeks before beginning the study. Patients previously intolerant to Azathioprine or 6-MP can start with the other thiopurine or with Methotrexate (MTX) per investigators discretion. Patient intolerant to standard doses of AZA or 6-MP can start at a lower dose or AZA or 6MP can be stopped per investigators discretion. However, if the immunomodulator is continued or introduced during screening period, the dose should remain stable for the duration of the trial, except if intolerance leading to discontinuation.

    Patients failing MTX can continue on MTX with infliximab

    Ongoing steroids are allowed if dose was stable 2 weeks before beginning the study with a maximum of prednisone 16 mg/d or budesonide 9 mg/day and should be tapered in 2 weeks.

    Patients who consent to receive Infliximab 5 mg/kg at week 0, 2 and 6 and further on every 8 weeks in conjunction with their current Azathioprine, 6-MP or MTX

    Women must have a contraceptive method
    E.4Principal exclusion criteria
    Absence of endoscopically visible ulcers
    Ongoing steroid therapy at doses > 16 mg/d prednisolone or equivalent
    Ongoing infections
    Previous use of IFX
    Prior use of biologic therapies excepted if a washout period of 8 weeks is respected
    Serious other diseases including cancer in the 5 years prior to inclusion excluding non-melanoma skin cancer
    Indication for immediate surgery
    Critical gastrointestinal stricture with obstructive symptoms and/or presence of abscess.
    Pregnant or breast-feeding woman.
    Positive fecal culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools
    Active tuberculosis. Positive tuberculosis screen per local guidelines
    Untreated latent tuberculosis, latent TB is allowed if treated for at least 6 months
    Patients with moderate or severe heart failure
    Patients with multiple sclerosis or lupus disease
    Patients with a history of hypersensitivity to infliximab, or to any of the excipients
    HIV, HBV, HCV viral infection (except the presence of positive anti-HBs antibodies) with serology not older than 3 months
    Azathioprine or 6-MP in combination with allopurinol or with other myelotoxic therapy (a washout period of 7 days is required for allopurinol or other myelotoxic therapy)
    Non-compliant subjects
    Participation in another therapeutic study
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the inter-individual variability of the pharmacokinetics of infliximab level and antibodies to infliximab during induction treatment and correlation with clinical response at W14 and W30
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoints of evaluation for the primary endpoint will be done at the end of induction treatment (at 6 weeks)

    The correlation between induction treatment and clinical response will be done at W14 and W30
    E.5.2Secondary end point(s)
    Proportion of patients in steroid-free remission at W10-14 w/o normal CRP and/or fecal calprotectin levels

    Sustained steroid-free clinical response at W30 w/o normal CRP and/or fecal calprotectin levels and mucosal healing

    Sustained steroid-free clinical remission at W30 w/o normal CRP and/or fecal calprotectin levels

    Correlation of patient population in third and fourth quartile of IFX levels during the induction phase (W0-W10) with clinical response or remission, and/or normal CRP and/or normal fecal calprotectin levels at W14 and 30

    Correlation of patient population in third and fourth quartile of IFX levels during the induction phase (W0-W10) with sustained IFX levels > 3 μg/ml at W14 and W30 without need for optimization

    Correlation of patient population in third and fourth quartile of IFX levels during the induction phase (W0-W10) with sustained IFX levels in third and fourth quartile at W14 and W30

    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints of evaluation for the secondary endpoints will be done at:
    - W10-14 for the first
    - W14 and W30 for the other secondary endpoints
    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 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 concerned8
    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 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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state80
    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)
    This trial is an observational study where the treatment is applied according the standards of practice. So, at the end of the study, the treatment remains identical with a classic follow-up.
    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 Decision2015-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-19
    P. End of Trial
    P.End of Trial StatusOngoing
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