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    Summary
    EudraCT Number:2021-002369-17
    Sponsor's Protocol Code Number:2021-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-02
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-002369-17
    A.3Full title of the trial
    Management of moderate POstoperative recurrence in Crohn's disease: a randoMizEd contROLled trial, the POMEROL trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Management of moderate POstoperative recurrence in Crohn's disease: a randoMizEd contROLled trial, the POMEROL trial.
    A.4.1Sponsor's protocol code number2021-01
    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 SponsorGETAID
    B.1.3.4CountryFrance
    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 supportCELLTRION
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGETAID
    B.5.2Functional name of contact pointMarie COISNON
    B.5.3 Address:
    B.5.3.1Street Address50 rue Richer
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75009
    B.5.3.4CountryFrance
    B.5.6E-mailprojet@getaid.org
    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 100 mg powder for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderCELLTRION
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 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/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 REMSIMA 120 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderCELLTRION
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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
    Crohn's disease patients having an i2 endoscopic postoperative recurrence 6-12 months after ileocolonic anastomosis.
    E.1.1.1Medical condition in easily understood language
    Crohn's disease patients having an i2 endoscopic postoperative recurrence 6-12 months after ileocolonic anastomosis.
    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 evaluate the proportion of CD patients without endoscopic postoperative recurrence (i0-i1) at 12 months (M12) in the arm receiving therapy escalation compared to status quo arm in patients having an i2 endoscopic postoperative recurrence 6-12 months after ileocolonic anastomosis.
    E.2.2Secondary objectives of the trial
    - To compare the proportions of patients with severe endoscopic recurrence (i3-i4) between both arms and the proportion of i2b-i3-i4 patients at 12 months (M12) between both arms
    - To compare the proportions of patients with clinical postoperative recurrence, surgical recurrence, need for endoscopic dilatation at 12 months (M12) between both arms.
    - To compare the mean change in Two Item Patient Reported Outcome (PRO2) from baseline to 12 months (M12) between both arms.
    - Evaluate the safety of therapy during the 12 months study period.
    - Evaluate the quality of life and work productivity impact during the 12 months study period.
    - To compare the clinical, endoscopic and surgical outcomes of 3 pre-specified subgroups: according to i2 subtype (i2a versus i2b patients), smoking status and immunosuppressant status.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1.Endoscopic ancillary study
    A post-hoc analysis of the centrally read videos will be performed. All videos recorded for the trial will be analysed. A specific endoscopic scoring sheet will be developed including detailed information on the localization of the lesions (blind loop, entry of the terminal ileum, anastomosis, precise distance from the anastomosis).

    2.Long-term follow-up ancillary study
    The primary objective of this study is to evaluate the benefit of CT-P13 treatment at 5 years in terms of preventing surgical postoperative recurrence compared to the status quo arm. The secondary objectives are to assess the benefit of CT-P13 treatment in terms of preventing clinical recurrence, surgical recurrence and need for endoscopic dilatation at 2, 3, 4 and 5 years and to evaluate the CT-P13 drug persistence.

    3. Ancillary studies based on biological collection
    A multi-omics analysis will be performed at KU Leuven using samples collected for biological collection, including blood and mucosal transcriptomics, genetic susceptibility analysis and metagenomics.

    4. Health economics
    Crohn’s disease related direct healthcare costs will be compared between the two treatment arms
    E.3Principal inclusion criteria
    - Age > 18 years
    - Diagnosis of Crohn's disease according to usual criteria
    - Intestinal resection with ileocolonic anastomosis removing all Crohn’s disease inflammatory lesions performed within the last 6-12 months (patients who underwent a two stage surgical procedure are also eligible if the endoscopic evaluation is performed 6-12 months after restoration of the fecal stream)
    - Postoperative endoscopy performed between 6 and 12 months +/- 2 months after ileocolonic anastomosis reaching the neoterminal ileum
    - Postoperative endoscopic recurrence classified i2 according to the Rutgeerts score at 6-12 months, validated by a blinded central reading
    - The patient is willing to start infliximab CT-P13 at a fixed schedule of 2 intravenous infusions at week 0 and week 2 followed by subcutaneous CT-P13 every other week from week 6 onwards
    E.4Principal exclusion criteria
    - Patients with an ostomy
    - Patients with ulcerative colitis or IBD type unclassified
    - Patients with an ileorectal or ileal pouch-anal anastomosis
    - Patients exposed to infliximab before index surgery with a primary non-response (no clinical effect after 2 infusions or at the discretion of the treating gastroenterologist) or history of infusion reactions to infliximab or history of detectable anti-infliximab antibodies
    - Patients with symptoms of active CD, defined as average daily SF ≥ 3.5 and average daily AP score ≥ 1.5, having started after a free interval without symptoms of one month after surgery
    - Patients with obstructive symptoms of CD defined by a CDOS > 4 (15) (see Appendix for description of the score). Asymptomatic patients receiving an endoscopic dilatation for a non-passable stenosis at baseline endoscopy in centres where it is a current practice to estimate the lesions extent can be included.
    - Patients treated with any biological therapy (except for intraocular injections) or an investigational medical product after index surgery
    - Patients having started thiopurines or methotrexate more than 6 weeks after ileocolonic anastomosis with restoration of the faecal stream
    - Patients in whom not all inflammatory lesions have been removed at index surgery: e.g. incomplete ileo-colonic resections, active colitis.
    - Patients with active perianal Crohn's disease
    - Patients with a contraindication to infliximab: cancer in the 5 years prior to inclusion, excluding non-melanoma skin cancer, active tuberculosis or untreated latent tuberculosis, moderate or severe heart failure, HIV or HBV infection (serology < 3 months), recent live vaccination (within 4 weeks of baseline).
    - Pregnant women
    - Patients under legal protection or unable to express their consent.
    - Patients not affiliated to a health insurance system.
    - Patients deprived of liberty by judiciary or administrative decision or hospitalized without consent or admitted in a sanitary or social institution for another reason than research.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the proportion of patients with a treatment success defined as an i0-i1 modified Rutgeerts score (mRS) at 12 months (M12)
    Treatment failure will be defined as:
    - Modified Rutgeerts score > i1 at 12 months (M12)
    - OR Clinical postoperative recurrence:
    Average daily stool frequency ≥ 3.5 and average daily abdominal pain score ≥ 1.5,
    AND
    * increased CRP compared to inclusion, at least + 10 mg/l
    * OR increased fecal calprotectin compared to inclusion, at least + 250 µg/g
    - OR Endoscopic dilatation defined as a need for a balloon insufflation at the ileocolonic anastomosis during an ileocolonoscopy when a non-passable stenosis was present in a patient having obstructive symptoms (Crohn Disease Obstructive Scale - CDOS > 4) before endoscopy. Endoscopic dilatation performed in asymptomatic patients in centres where it is a current practice to estimate the lesions extent will not be considered for this criterion.
    - OR Surgical recurrence within 12 months study period defined as a need for a new ileocolonic resection.
    - OR Active perianal Crohn's disease or other Crohn's disease location (e.g. colitis, jejunitis) leading to a treatment modification (initiation of a new Crohn's disease therapy including steroids or CT-P13 optimization) before 12 months ileocolonoscopy.
    - OR Definitive treatment discontinuation
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 12 months
    E.5.2Secondary end point(s)
    - Proportion of patients with an i3-i4 mRS at 12 months (M12)
    - Proportion of patients with an i2b-i3-i4 mRS at 12 months (M12)
    - Proportion of patients with an i0 mRS at 12 months (M12)
    - Two item Patient Reported Outcome (PRO2) at 12 months (13) (M12)
    - Clinical postoperative recurrence within 12 months after randomization : average daily stool frequency ≥ 3.5 AND average daily abdominal pain score ≥ 1.5 (14),
    AND
    increased CRP compared to inclusion, at least + 10 mg/l OR increased fecal calprotectin compared to inclusion, at least + 250 µg/g
    - Surgical recurrence within 12 months: need for a new ileocolonic resection
    - Endoscopic dilatation within 12 months: need for a balloon insufflation at the ileocolonic anastomosis during an ileocolonoscopy when a non-passable stenosis was present in patient with obstructive symptoms (Crohn's disease obstructive score>4 (15)) before endoscopy
    - Time to clinical postoperative recurrence
    - Serious adverse events
    - Quality of life: EQ5D-5L
    - Work productivity: Work Productivity and Activity Impairment questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    at M4, M8 and M12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    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 Yes
    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
    Therapeutic strategy : Conventional treatments versus therapy escalation
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    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 years
    E.8.9.1In the Member State concerned months30
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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) 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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 180
    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)
    Not applicable as Remsima SubCutaneous has the authorisation and will be used as standard of care.
    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 Decision2021-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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