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    Summary
    EudraCT Number:2016-000152-96
    Sponsor's Protocol Code Number:2016-01
    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:2019-11-22
    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 number2016-000152-96
    A.3Full title of the trial
    Intensive Treatment to Reach the target with Golimumab in ulcErative coliTis – In-TARGET
    Traitement intensif par golimumab pour atteindre la cible thérapeutique dans la rectocolite hémorragique (RCH) - In-TARGET
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intensive Treatment to Reach the target with Golimumab in ulcErative coliTis – In-TARGET
    Traitement intensif par golimumab pour atteindre la cible thérapeutique dans la rectocolite hémorragique (RCH) - In-TARGET
    A.3.2Name or abbreviated title of the trial where available
    In-TARGET
    In-TARGET
    A.4.1Sponsor's protocol code number2016-01
    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 supportPharmaceutical company
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Liège
    B.5.2Functional name of contact pointStudy Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressDomaine Universitaire du Sart Tilman, Bât. B35
    B.5.3.2Town/ cityLiège
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3242844495
    B.5.5Fax number3243667889
    B.5.6E-mailswertz@chuliege.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 SIMPONI 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B.V.
    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.3.4Pharmaceutical form Solution for 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 INNGOLIMUMAB
    D.3.9.1CAS number 476181-74-5
    D.3.9.3Other descriptive nameSIMPONI
    D.3.9.4EV Substance CodeSUB25638
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 SIMPONI 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics B.V.
    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.3.4Pharmaceutical form Solution for 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 INNGOLIMUMAB
    D.3.9.1CAS number 476181-74-5
    D.3.9.3Other descriptive nameSIMPONI
    D.3.9.4EV Substance CodeSUB25638
    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
    Moderate to severe ulcerative colitis
    Rectocolite hémorragique modérée à sévère
    E.1.1.1Medical condition in easily understood language
    Moderate to severe ulcerative colitis who failed corticosteroids and immunosuppressive therapy, or are intolerant to immunosuppressors.
    Rectocolite hémorragique (RCH) modérée à grave pour laquelle un traitement avec des anticorps dirigés contre le facteur de nécrose tumorale (TNF) est jugé nécessaire.
    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 determine the proportion of patients with Continuous Clinical Response (CCR) and endoscopic remission after one year of golumimab at week 54.
    Déterminer la proportion de patients présentant une réponse clinique continue (RCC) et une rémission endoscopique à la semaine 54.
    E.2.2Secondary objectives of the trial
    To determine the proportion of patients in CCR with MH at week 108, after discontinuation or dose de-escalation of golimumab treatment in the group of patients in CCR and with MH at week 54
    Factors associated with treatment success
    Efficacy of dose optimization in patients who loose response between week 10 and 54
    Clinical remission at week 54 and 108
    Partial MAYO score at week 54 and 108
    PRO2 at week 54 and 108
    CCR between study inclusion and week 54 and 108
    Steroid-free clinical remission at week 54 and 108
    MH at week 54 and 108
    Changes in faecal calprotectin levels from baseline to week 54 and 108
    Colectomy between W0 and W54 and 108
    UC-related hospitalizations throughout the trial
    Histological remission at W54 and 108
    Fatigue (FACIT), disability (IBD Disability index), QoL (SHS-IBD VAS)
    Golimumab PK data
    Proportion of late responders being in Clinical Response from week 18 to week 54 and with MH at week 54 following treatment intensification in Maintenance Phase
    Evaluer la proportion de patients en RCC à la S108, après arrêt ou désescalade du golimumab dans le groupe des patients avec une RCC et une CM à sem 54.
    Facteurs associés à la réussite du traitement
    Efficacité de la dose d'optimisation chez les patients qui n'ont pas de réponse entre s10 et s54
    Rémission clinique à s54 et s108
    Score MAYO partiel à s54 et s108
    PRO2 à s54 et s108
    RCC entre l'inclusion et s54 et s108
    Rémission clinique sans stéroïdes à s54 et s108
    CM à s54 et 108
    Changements dans les niveaux de calprotectine fécale de la baseline à s54 et s108
    Colectomie entre s0, s54 et s108
    Hospitalisations liées à une UC durant l'étude
    Rémission histologique à s54 et s108
    Fatigue (FACIT), le handicap (IBD index des personnes handicapées), la qualité de vie (SHS-IBD VAS)
    Données de PK du golimumab
    Proportions de patients qui ont une réponse clinique tardive de la semaine 18 à la semaine 54 et une CM à s54 suite à l'intensification de traitement dans la phase d'entretien
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years and < 75 years
    - Established diagnosis of UC for at least 3 months (pancolitis, leftsided colitis, proctosigmoiditis and or proctitis are allowed).
    - Adults with moderately-to-severely active UC who had an inadequate response to or failed to tolerate steroids AND thiopurines (azathioprine or 6-mercaptopurine), or adults with moderately-to-severely active UC who had no response to an adequate steroid course and starting golimumab.
    - Active disease at golimumab treatment initiation defined as a total MAYO score ≥6 with an endoscopic sub score ≥ 2.
    - Patients concurrently treated with oral corticosteroids will receive a stable dose (prednisone ≤20 mg/day for at least 2 weeks) before baseline.
    - Patient has to be treated with oral 5-ASA at time of inclusion regardless of the dose if no contra-indication; if the patient is not on oral 5-ASA during the screening period, he/she should start mesalamine at 2g per day or asacol at 1.6 g per day in the absence of contra-indication.
    - Patients are allowed stable dose of thiopurines (azathioprine or 6-mercaptopurine stable dose for at least 4 weeks).
    - Naïve to anti-TNF therapy, and other biologics, including anti-integrin antibodies and for all biologics known to be effective for UC (approved or investigational).
    - Naïve to JAK inhibitors (approved or investigational)
    - A contraceptive method during the whole study for childbearing potential female patients.
    - Age ≥ 18 ans et <75 ans
    - Diagnostic établi de la RCH depuis au moins 3 mois
    - Adultes avec une RCH modérée à sévère qui ont eu une réponse inadéquate à ou ont échoué à tolérer l'administration de stéroïdes ET thiopurines (azathioprine ou 6-mercaptopurine), ou adultes avec une RCH modérée à sévère qui n'ont pas de réponse à un traitement adéquat par stéroïdes et commence le golimumab.
    - Maladie active à l'initiation du traitement au golimumab définie par un score de MAYO total ≥6 avec un sous score endoscopique ≥ 2.
    - Les patients traités simultanément par des corticostéroïdes oraux recevront une dose stable (prednisone ≤ 20 mg / jour pendant au moins 2 semaines) avant la visite de baseline.
    - Les patients doivent être traité par 5-aminosalicylates oraux au moment de l'inclusion, indépendamment de la dose, en l'absence de contre-indication; si le patient n'est pas traité par 5-aminosalicylates oraux pendant la période de screening, il/elle devra démarrer un traitement par mesalamine 2g/jour ou asacol 1.6 g/jour, en l'absence de contre-indication.
    - Les patients sont autorisés à prendre des doses stable de thiopurines (azathioprine ou 6-mercaptopurine à dose stable pendant au moins 4semaines).
    - Patients naïfs de la thérapie anti-TNF et d'autres produits biologiques connus efficaces pour la RCH, y compris les anticorps anti intégrine (approuvés ou expérimentaux).
    - Patients naïfs aux inhibiteurs JAK (approuvés ou expérimentaux).
    - Utilisation d'une méthode de contraception pendant toute la durée de l'étude pour les femmes en âge de procréer.
    E.4Principal exclusion criteria
    - Age under 18 and over 75.
    - People unable to give their consent (because of their physical or mental state).
    - Absence of written consent.
    - Pregnancy or breastfeeding.
    - Patients with severe acute colitis or patients at imminent risk for colectomy.
    - History of colectomy.
    - History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed.
    - Screening stool study positive for enteric pathogens or Clostridium difficile toxin.
    - Oral corticosteroids at a dose > 20 mg prednisone or its equivalent per day.
    - Any current or previous use of anti-TNF therapy, and other biologics, including anti-integrin antibodies (approved or investigational), JAK inhibitors (approved or investigational), or any current or previous use of an investigational agent within 5 half-lives of that agent before the first study agent injection.
    - Contraindication to anti-TNF therapy according to drug labelling:
    o Active infection.
    o Non-treated latent tuberculosis.
    o Heart failure (NYHA: Grade III and IV).
    o Malignancy during the previous 5 years.
    - Age moins de 18 ans et plus de 75.
    - Personnes incapables de donner leur consentement (en raison de leur état physique ou mental).
    - Absence de consentement écrit.
    - Grossesse ou allaitement.
    - Les patients atteints de colite aiguë sévère ou les patients ayant un risque imminent de colectomie.
    - Antécédent de colectomie.
    - Antécédents de dysplasie de la muqueuse du côlon ou de polypes adénomateux du côlon non réséqués.
    - Dépistage positif dans les selles pour des pathogènes entériques ou la toxine de Clostridium difficile.
    - Corticostéroïdes oraux à une dose > 20 mg/jour de prednisone ou son équivalent.
    - Toute utilisation actuelle ou antérieure de traitement anti-TNF et d'autres produits biologiques, y
    compris les anticorps anti-intégrine (approuvés ou expérimentaux), des inhibiteurs de JAK ( approuvés ou expérimentaux), ou toute utilisation actuelle ou antérieure d'un agent expérimental à 5 demi-vies de cet agent avant la première injection de l'agent de l'étude.
    - Contre-indication au traitement anti-TNF selon l'étiquetage des médicaments:
     infection active.
     non-traité la tuberculose latente.
     L'insuffisance cardiaque (NYHA: Grade III et IV).
    malignité au cours des 5 années précédentes .
     maladie neurologique démyélinisante .
    E.5 End points
    E.5.1Primary end point(s)
    • Week 10-54: proportion of patients in CCR and with MH (endoscopic Mayo score of 0 or 1) at week 54
    Semaine 10-54 : évaluer la proportion de patients présentant une RCC et une CM à la semaine 54 (score Mayo endoscopique de 0 ou 1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 10-54
    Semaine 10-54
    E.5.2Secondary end point(s)
    For all included patients:
    • Phase II (week 54-108): proportion of patients in CCR with MH (endoscopic Mayo score of 0 or 1) at week 108, after discontinuation or dose deescalation (from 100 to 50 mg) of golimumab treatment at year 1 in the subgroup of patients in CCR and with MH (endoscopic Mayo score of 0 or 1) at week 54
    • Factors associated with treatment success (see primary endpoints)
    • Efficacy of dose optimization in patients who loose response between week 10 and 54
    • Clinical remission at week 54
    • Clinical remission at week 108
    • Partial MAYO score at week 54 and 108
    • PRO2 (Partial Mayo minus PGA) at week 54 and 108
    • CCR between study inclusion and week 54 and 108
    • Steroid-free clinical remission at week 54 and 108
    • MH (endoscopic score MAYO 0-1) at week 54 and 108
    • Changes in faecal calprotectin levels from baseline at week 54 and 108
    • Colectomy between W0 and W54 and 108
    • UC-related hospitalizations throughout the trial
    • Histological remission at W54 and 108
    Fatigue (FACIT), disability (IBD Disability index), QoL (SHS-IBD VAS)
    Golimumab PK data
    Proportion of late responders being in Clinical Response from week 18 to week 54 and with MH at week 54 following treatment intensification in Maintenance Phase
    • Proportion de patients en RCC avec une MC à la semaine 108, après un arrêt ou une désascalade (de 100mg à 50mg) de traitement golimumab à l'année 1 dans le sous groupe de patients en RCC et en MC à la semaine 54
    • Les facteurs associés à la réussite du traitement (voir critères d'évaluation primaires)
    • Efficacité de la dose d'optimisation chez les patients qui n'ont pas de réponse entre les semaines 10 et 54
    • La rémission clinique à la semaine 54 et 108
    • Score MAYO partiel à la semaine 54 et 108
    • PRO2 (Mayo partiel moins PGA) à la semaine 54 et 108
    • RCC entre l'inclusion dans l'étude et la semaine 54 et 108
    • Rémission clinique sans stéroïdes à la semaine 54 et 108
    • CM (score endoscopique MAYO 0-1) à la semaine 54 et 108
    • Les changements dans les niveaux de calprotectine fécale de la baseline à la semaine 54 et 108
    • Colectomie entre semaine 0 et semaine 54 et semaine 108
    • Hospitalisations liées à une UC durant l'étude
    • Rémission histologique à la semaine 54 et la semaine 108
    • Questionnaires PRO : fatigue (FACIT), le handicap (IBD index des personnes handicapées), la qualité de vie (SHS-IBD VAS)
    • Données de PK (concentrations minimales de golimumab et des anticorps contre le golimumab)
    • Proportions de patients qui ont une réponse clinique tardive de la semaine 18 à la semaine 54 et une CM à la semaine 54 suite à l'intensification de traitement dans la phase d'entretien
    • Pour les patients non-répondeurs primaires aux golimumab à la semaine 10, nous allons évaluer l'efficacité de l'optimisation du traitement, y compris le pourcentage de patients en réponse clinique de la semaine 18 à la semaine 54 et CM à la semaine 54.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 10, 54 et 108
    Semaine 10, 54 et 108
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Yes
    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
    LPLV
    DPDV
    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 months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months48
    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: 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 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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
    non applicable
    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 Decision2019-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-09
    P. End of Trial
    P.End of Trial StatusOngoing
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