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    Summary
    EudraCT Number:2020-006022-32
    Sponsor's Protocol Code Number:P160922
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-01-18
    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 number2020-006022-32
    A.3Full title of the trial
    TNF-alpha antagonists (Infliximab) withdrawal in sarcoidosis : a prospective, randomized, controlled trial
    Retrait des antagonistes du TNF-alpha (Infliximab) dans la sarcoïdose: un essai prospectif, randomisé et contrôlé
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language





    TNF-alpha antagonists (Infliximab) withdrawal in sarcoidosis : a prospective, randomized, controlled trial





    Retrait des antagonistes du TNF-alpha (Infliximab) dans la sarcoïdose: un essai prospectif, randomisé et contrôlé
    A.4.1Sponsor's protocol code numberP160922
    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 SponsorAssistance Publique Hôpitaux de Paris (APHP)
    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 supportPHRC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPHP
    B.5.2Functional name of contact pointClinical Research and Developpement
    B.5.3 Address:
    B.5.3.1Street AddressAvenue Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+3306 09 62 67 16
    B.5.6E-mailjean-luc.joannic@aphp.fr
    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 No
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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 typerange
    D.3.10.3Concentration number3 to 5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmethotrexate
    D.3.9.3Other descriptive nameMETHOTREXATE
    D.3.9.4EV Substance CodeSUB08856MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/h milligram(s)/hour
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.044 to 0.059
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 446-86-6
    D.3.9.3Other descriptive nameAZATHIOPRINE
    D.3.9.4EV Substance CodeSUB05647MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg/h milligram(s)/kilogram/hour
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0,041 to 0,083
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    sarcoidosis
    SarcoÏdose
    E.1.1.1Medical condition in easily understood language
    Sarcoïdosis
    Sarcoïdose
    E.1.1.2Therapeutic area Not possible to specify
    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 2 strategies of remission maintenance in patients who are in remission after infliximab administration
    The primary endpoint is the percentage of patients with major relapses in the 2 groups
    Comparer 2 stratégies de maintien de la rémission chez les patients en rémission après l'administration d'infliximab
    Le critère principal est le pourcentage de patients avec des rechutes majeures dans les 2 groupes
    E.2.2Secondary objectives of the trial
    To compare the percentage of patients with minor relapses in the 2 groups
    To compare the rates of adverse events
    To determine which are the predictors of relapses
    To compare the quality of life in the 2 groups
    Comparer le pourcentage de patients présentant des rechutes mineures dans les 2 groupes
    Comparer les taux d'événements indésirables
    Déterminer quels sont les prédicteurs des rechutes
    Comparer la qualité de vie dans les 2 groupes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age superior or equal to 18 years
    Clinical and radiological presentation consistent with sarcoidosis
    Presence of non-caseating granulomas in at least one organ
    Exclusion or other causes of granulomas
    Infliximab treatment for at least 6 months
    Steroid dosage < or equal to 10 mg/day for at least 6 months
    No activity of the disease (ePOST score 0) for at least 6 months
    Normal ACE and serum calcemia level
    Signed informed consent
    Affiliated to the National French social security system

    As infliximab is the most used TNF-alpha antagonists, we decided to include only patients treated with infliximab to increase the homogeneity.
    Âge supérieur ou égal à 18 ans
    Présentation clinique et radiologique conforme à la sarcoïdose
    Présence de granulomes épithélioïdes sans nécrose caséeusedans au moins un organe
    Exclusion ou autres causes de granulomes
    Traité par Infliximab pendant au moins 6 mois
    Dosage de stéroïde <ou égal à 10 mg / jour pendant au moins 6 mois
    Aucune activité de la maladie (score ePOST 0) pendant au moins 6 mois
    Niveau normal de l'ACE et de la calcémie sérique
    Consentement éclairé signé
    Affilié ou ayant droit du régime de sécurité sociale français

    Étant donné que l'infliximab est l'antagoniste du TNF-alpha le plus utilisé, nous avons décidé d'inclure uniquement les patients traités par infliximab pour augmenter l'homogénéité.
    E.4Principal exclusion criteria
    Pregnancy or breast-feeding
    Positive IGRA test without previous antituberculous antibiotherapy
    Active infection
    History of cancer in the 5 years before enrolment (except for cutaneous non melanoma cancers)
    Concurrent vaccination with live vaccines during therapy
    Inability to understand information about protocol
    Adult subject under legal protection or unable ton consent
    Absence of effective contraceptive method for men and women for duration of the study and 6 months after the end of participation
    Concomitant participation to another biomedical research (only Category 1 trial according to the Jardé law)
    Patiente enceinte ou allaitante
    Test IGRA positif sans antibiothérapie antituberculeuse antérieure
    Infection active
    Cancer (sauf cancer cutané non mélanomateux) diagnostiqué au cours des 5 dernières années Vaccination actuelle avec des vaccins vivants pendant le traitement
    Incapacité de comprendre l'information sur le protocole
    Sujet adulte sous protection légale ou incapable de consentir
    Absence de contraception efficace pendant la durée de l’étude et pendant les 6 mois après la fin de participation
    Participation concommitante à une autre recherche biomédicale (uniquement essai de catégorie 1 selon la loi Jardé)
    E.5 End points
    E.5.1Primary end point(s)
    To compare 2 strategies of remission maintenance in patients who are in remission after infliximab administration
    The primary endpoint is the percentage of patients with major relapses in the 2 groups
    Comparer 2 stratégies de maintien de la rémission chez les patients en rémission après administration d'infliximab
    Le critère d'évaluation principal est le pourcentage de patients présentant des rechutes majeures dans les 2 groupes
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    E.5.2Secondary end point(s)
    12 months
    12 mois
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    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 No
    E.6.5Efficacy No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    methotrexate 0.3 mg/kg/semaine (ou azathioprine 2 mg/Kg/jour ou 1 mg/kg/jour si métabolisme TPMT in
    Infliximab 3 à 5 mg/kg toutes les 4 à 8 semaines, methotrexate 7.5-10 mg/semaine (ou azathioprine 1
    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 concerned16
    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
    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 months
    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: 90
    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 state130
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 130
    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)
    Patient will revert to standard treatment of care
    Le patient reviendra au traitement standard des soins

    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 Decision2021-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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