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    Summary
    EudraCT Number:2019-002959-42
    Sponsor's Protocol Code Number:201712028
    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:2019-11-19
    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 number2019-002959-42
    A.3Full title of the trial
    Optimization of the use of anti-TNF antibodies in Verneuil's disease: Interest of a systematic initial prescription of methotrexate
    Optimisation de l’utilisation des anticorps anti-TNF dans la maladie de Verneuil : Intérêt d’une prescription initiale systématique de méthotrexate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimization of the use of anti-TNF antibodies in Verneuil's disease: Interest of a systematic initial prescription of methotrexate
    Optimisation de l’utilisation des anticorps anti-TNF dans la maladie de Verneuil : Intérêt d’une prescription initiale systématique de méthotrexate
    A.3.2Name or abbreviated title of the trial where available
    ADHAS
    ADHAS
    A.4.1Sponsor's protocol code number201712028
    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 SponsorGroupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche
    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 supportGroupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationECTEN
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address81 rue Rosa Bonheur
    B.5.3.2Town/ cityLA ROCHETTE
    B.5.3.3Post code77000
    B.5.3.4CountryFrance
    B.5.4Telephone number330664888704
    B.5.6E-mailmh.barba@ecten.eu
    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 HUMIRA®
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameHumira®
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 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) Yes
    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 IMETH®
    D.2.1.1.2Name of the Marketing Authorisation holderNORDIC GROUP B.V
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameIMETH®
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Yes
    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
    patient suffering from Verneuil's disease: Hurley II and III stages
    Patient souffrant de la maladie de Verneuil stade Hurley II et Stages III
    E.1.1.1Medical condition in easily understood language
    The Hidradenitis suppurativa also know Verneuil desease’s is a chronic skin disease characterized by recurrent boil-like lumps (nodules) under the skin. The nodules become inflamed and painful.
    La maladie de Verneuil est une maladie chronique de la peau caractérisée par l'apparition de nodules sous la peau qui peuvent devenir très douloureux
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    Evaluate the clinical effect at 6 months of the anti-TNF (adalimumab) + methotrexate versus anti-TNF alone (adalimumab) combination in patients with Verneuil's disease.
    Évaluer l'effet clinique à 6 mois de l'association anti-TNF (adalimumab) + méthotrexate versus anti-TNF seul (adalimumab) chez des patients atteints de la maladie de Verneuil.
    E.2.2Secondary objectives of the trial
    - Evaluate the clinical effect of the anti-TNF (adalimumab) + methotrexate versus anti-TNF alone (adalimumab) combination with M1, M3 and M9.
    - Evaluate the circulating levels of adalimumab at M0, M3 and M6
    - Evaluate the presence of ADA at M0, M3 and M6
    - Find out a correlation between biological response and clinical response
    - Evaluating the adverse effects
    Évaluer l'effet clinique de l'association anti-TNF (adalimumab) + méthotrexate par rapport à anti-TNF seul (adalimumab) avec M1, M3 et M9.
    - Évaluer les niveaux d’adalimumab en circulation à M0, M3 et M6
    - Evaluer la présence d'ADA à M0, M3 et M6
    - Trouver une corrélation entre la réponse biologique et la réponse clinique
    - évaluation des effets indésirables
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female or male
    - Age >18 years
    - Diagnosis of Verneuil's disease: stages of Hurley II and III
    - No more than 20 abscesses or inflammatory nodules
    - Written informed consent
    - Patient affiliated or beneficiary of a social security
    - Femme homme
    - Age> 18 ans
    - Diagnostic de la maladie de Verneuil: stades de Hurley II et III
    - Pas plus de 20 abcès ou nodules inflammatoires
    - Consentement éclairé écrit
    - Patient affilié ou bénéficiaire d'une sécurité sociale
    E.4Principal exclusion criteria
    - Age < 18 years
    - Stage III or IV heart failure
    - Positive HIV serology
    - Hepatitis C or B positive serology
    - Latent tuberculosis (positive quantiferon)
    - Severe hepatic insufficiency
    - Previous treatments with adalimumab or infliximab.
    - Severe progressive hepatic disease
    - Cancer treatment under 5 years
    Age <18 ans
    - insuffisance cardiaque de stade III ou IV
    - sérologie positive du VIH
    - sérologie positive pour l'hépatite C ou B
    - Tuberculose latente (quantiferon positif)
    - insuffisance hépatique sévère
    Traitements antérieurs avec adalimumab ou infliximab.
    - Maladie hépatique progressive sévère
    - Traitement du cancer de moins de 5 ans
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the clinical response rate at Month 6, determined by Hidradenitis Suppurativa Clinical Response (HiSCR).
    Le critère d'évaluation principal est le taux de réponse clinique au 6e mois, déterminé par la réponse clinique de l'hidradénite suppurée (HiSCR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    This score is validated and used in the trials to count the abscesses in Verneuil's disease and to evaluate the therapeutic results. The clinical response rate, determined by the HiSCR, is defined by:
    - A reduction of at least 50% compared to the initial evaluation of the total number of inflammatory abscesses and nodules
    - No increase in the number of abscesses or draining fistulas.
    Ce score est validé et utilisé dans les essais cliniques pour comptabiliser les abcès de la maladie de Verneuil et évaluer les résultats thérapeutiques. Le taux de réponse clinique, déterminé par le HiSCR, est défini par:
    - une réduction d'au moins 50% par rapport à l'évaluation initiale du nombre total d'abcès et de nodules inflammatoires
    - Pas d'augmentation du nombre d'abcès ou de fistules drainantes.
    E.5.2Secondary end point(s)
    This score is validated and used in the trials to count the abscesses in Verneuil's disease and to evaluate the therapeutic results. The clinical response rate, determined by the HiSCR, is defined by:
    - A reduction of at least 50% compared to the initial evaluation of the total number of inflammatory abscesses and nodules
    - No increase in the number of abscesses or draining fistulas.
    Ce score est validé et utilisé dans les essais cliniques pour comptabiliser les abcès de la maladie de Verneuil et évaluer les résultats thérapeutiques. Le taux de réponse clinique, déterminé par le HiSCR, est défini par:
    - une réduction d'au moins 50% par rapport à l'évaluation initiale du nombre total d'abcès et de nodules inflammatoires
    - Pas d'augmentation du n
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Clinical response rate at M1, M3 and M9, determined by the "HiSCR".
    - Circulating levels of adalimumab at M0, M3 and M6: plasma adalimumab assay (kits available).
    - Plasma levels are expected to collapse in the event of resistance
    - Appearance of blocking agents at M0, M3 and M6: blood test (kits available)
    - Correlation between biology and clinic: "HiSCR" score and plasma adalimumab
    - Adverse effects
    Taux de réponse clinique à M1, M3 et M9, déterminé par le "HiSCR".
    - Niveaux circulants d'adalimumab aux niveaux M0, M3 et M6: dosage plasmatique de l'adalimumab (kits disponibles).
    - Les niveaux de plasma devraient s’effondrer en cas de résistance
    - Apparence des agents bloquants à M0, M3 et M6: prise de sang (kits disponibles)
    - Corrélation entre biologie et clinique: score "HiSCR" et adalimumab plasmatique
    - effets indésirables
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 Yes
    E.8.1.7.1Other trial design description
    longitudinale
    longitudinale
    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 concerned6
    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
    Dernière visite du dernier patient
    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: 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.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)
    At the end of the clinical trial the subject will receive usual treatment
    A la fin de la recherche le patient recevra son traitement habituel
    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 Decision2020-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-13
    P. End of Trial
    P.End of Trial StatusOngoing
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