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    EudraCT Number:2018-002114-13
    Sponsor's Protocol Code Number:P170910J
    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:2019-03-26
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2018-002114-13
    A.3Full title of the trial
    Efficacy of Colchicine to prevent skin relapses in adult's IgA vasculitis
    Efficacité de la colchicine pour prévenir les rechutes cutanées au cours de la vascularite à IgA de l'adulte
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of Colchicine to prevent skin relapses in adult's IgA vasculitis
    Efficacité de la colchicine pour prévenir les rechutes cutanées au cours de la vascularite à IgA de l'adulte
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberP170910J
    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.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 supportDGOS
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.2Functional name of contact pointDRCI Hôpital Saint Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.4Telephone number00331 44 84 17 33
    B.5.5Fax number00331 44 84 17 01
    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. name COLCHICINE OPOCALCIUM 1 mg, comprimé sécable
    D. of the Marketing Authorisation holderMayoly Spindler
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNColchicine
    D.3.9.1CAS number 64-86-8
    D.3.9.2Current sponsor codeCOLCHICINE OPOCALCIUM
    D.3.9.3Other descriptive nameCOLCHICINE
    D.3.9.4EV Substance CodeSUB01420MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Immunoglobulin A vasculitis
    vascularite à Immunoglobuline A
    E.1.1.1Medical condition in easily understood language
    Ig A vasculitis
    vascularite à IgA
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10047121
    E.1.2Term Vasculitis Henoch-Schonlein like
    E.1.2System Organ Class 100000004858
    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 efficacy of colchicine versus placebo to prevent cutaneous relapses, 6 months after inclusion, in adult patients with cutaneous IgA vasculitis alone or associated with non-severe digestive or renal involvement.
    Evaluation de l'efficacité de la colchicine par rapport au placebo pour prévenir les rechutes cutanées, 6 mois (M6) après l'inclusion, chez des patients adultes présentant une vascularite à IgA cutanée isolée ou associée à une atteinte digestive ou rénale non sévère.
    E.2.2Secondary objectives of the trial
    1/ To assess efficacy of colchicine vs. placebo at M6 in:
    - Preventing cutaneous relapses
    - Preventing extra-cutaneous (articular and/or digestive and/or kidney) new involvements or relapses
    2/ To assess a remanent effect of colchicine vs. placebo at M12 in:
    - Preventing cutaneous relapses
    - Preventing extra-cutaneous (articular and/or digestive and/or kidney) new involvements or relapses
    3/ To assess efficacy of colchicine vs. placebo in preventing relapses consequence
    4/ To assess colchicine safety (adverse events) and compliance
    1/ Evaluer l’efficacité de la colchicine/placebo pour
    -Prévenir les rechutes cutanées
    -Prévenir l’apparition ou la rechute des atteintes extra-cutanées (articulaire, digestive, rénale).
    2/ Evaluer l’effet rémanent de la colchicine/placebo en évaluant à 1 an (6 mois après l’arrêt du traitement) les rechutes cutanées et extra-cutanées.
    3/ Evaluer l’efficacité de la colchicine/placebo pour prévenir les conséquences des rechutes cutanées en utilisant des scores de qualité de vie (SF-36 et HAQ ) et en comptabilisant les jours d’arrêt de travail en rapport avec la maladie.
    4/ Evaluer la tolérance (effets secondaires) et la compliance au traitement (colchicine/placebo).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Age ≥ 18 years and < 85 years
    b) IgA-V recently diagnosed (< 20 days since skin biopsy) and defined by :
    - Histologically proven small vessels vasculitis with IgA deposits IgA Vasculitis
    - Purpura and/or involvement of at least one organ among kidney, joint, or intestinal tract
    a) Age ≥18 ans et < 85 ans
    b) V-IgA de diagnostic récent (moins de 20 jours suivant la biopsie cutanée) et défini par :
    - V-IgA prouvé histologiquement (vascularite des petits vaisseaux avec dépôt d’IgA)
    - purpura et/ou atteinte d’au moins un organe parmi: rein, articulation, tube digestif.
    E.4Principal exclusion criteria
    a) Severe renal IgA vasculitis:
    - impaired renal function, defined as an eGFR < 60 ml per minute per 1.73 m2 (MDRD or CKD-EPI formula)
    - proteinuria/creatiniuria> 1g/l
    - Uncontrolled blood pressure (Systolic blood pressure > 170 mmHg, diastolic blood pressure > 100 mmHg)
    b) Severe digestive IgA vasculitis:
    - intussusception
    - massive gastrointestinal haemorrhage
    - intestinal ischemia
    - perforation
    - abdominal pain persisting more than one day (EVA > 5) and unresponsive to standard analgesics (level 1 or 2).
    c) Prior (< 3 months) immunosuppressive or corticosteroid therapy
    d) Additional cutaneous, and/or digestive and/or chronic renal diseases.
    e) HIV and B and C Chronic hepatitis
    f) Pregnancy or breast feeding or women without sufficient contraception among women of childbearing
    g) Known allergy or intolerance to study medication or any of its excipients (lactose, saccharose)
    h) Contraindication to colchicine such as:
    - severe hepatic insufficiency
    - combination with a macrolide (except spyramicin),
    - combination with pristinamycin
    i) Participation in another interventional trial
    j) Patient having not signed an informed consent
    k) Patient without Social Security System Insurance
    a) V-IgA avec atteinte rénale sévère :
    - Altération de la fonction rénale définie par un DFGe <60ml/min/1.73 m2 (MDRD ou CKD-EPI)
    - Ratio protéinurie/créatininurie> 1g/g l
    - Pression artérielle non contrôlée (PAs >170 mmHg, PAd > 100 mmHg)
    b) V-IgA avec atteinte digestive sévère :
    - Invagination
    - Hémorragie digestive massive
    - Ischémie digestive
    - Perforation
    - Douleurs abdominales persistantes plus d’une journée, évalué à plus de 5 sur échelle EVA et résistantes aux antalgiques usuels (classe 1 et 2).
    c) Traitement immunosuppresseur ou corticothérapie récente (<3 mois)
    d) Comorbidité dermatologique, digestive ou rénale
    e) HIV, infection chronique par hépatite B ou C.
    f) Grossesse, allaitement, absence de contraception chez les femmes en âge de procréer
    g) Allergie ou intolérance connue à la colchicine ou à ses excipients (lactose, saccharose)
    h) Contre-indications à la colchicine telles que : insuffisance hépatique sévère, association avec un macrolide (sauf spyramicine), association avec la pristinamycine
    i) Participation à une autre étude interventionnelle
    j) Patient n’ayant pas signé de consentement
    k) Patient sans sécurité sociale
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients who have presented at least one cutaneous relapse in the colchicine group versus the placebo group, 6 months after inclusion. Cutaneous relapse is defined by reappearance of palpable purpura with lower limb predominance and not related to thrombocytopenia.
    nombre de patients qui ont présenté au moins une rechutes cutanée à 6 mois.
    La rechute cutanée est définie par : Apparition de nouvelles lésions cutanées, à prédominance déclive, sans rapport avec une thrombopénie
    E.5.1.1Timepoint(s) of evaluation of this end point
    Number of patients who have presented at least one cutaneous relapse 6 months after inclusion
    nombre de patients qui ont présenté au moins une rechutes cutanée à 6 mois après l'inclusion.
    E.5.2Secondary end point(s)
    - Time (in days) to first cutaneous relapse
    - Number of cutaneous relapses per patients at M6 and M12
    - Rate of patients who have presented at least a severe cutaneous relapse at M0, M6 and M12
    - 36-item Short-form Health Survey (SF-36) score at M6 and M12
    - Rate of patients displaying at least one work stoppage related to IgAV between M0 and M12 and number of days of work stoppage per patient.
    - Rate of patient who consulted in emergency for IgA relapse or new organ involvement between M0 and M12.
    - Adverse events associated with Colchicine and compliance at M3 and M6
    - Clinical, biological and histological candidate predictors at diagnosis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 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. 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned32
    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 years
    E.8.9.1In the Member State concerned months48
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state264
    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)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-20
    P. End of Trial
    P.End of Trial StatusOngoing
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