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    Summary
    EudraCT Number:2020-002206-10
    Sponsor's Protocol Code Number:APHP190891
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-30
    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 number2020-002206-10
    A.3Full title of the trial
    A prospective study of the safety and efficacy of the use of a Lipiodol Emulsion for the embolization of inflammatory hypervascularizations observed in patients with articular or abarticular pain in the knee - LipioJoint 1
    Étude prospective de sécurité et d'efficacité d'utilisation d'une émulsion de Lipiodol pour l'embolisation des hypervascularisations inflammatoires observées chez des patients ayant des douleurs articulaires ou abarticulaires du genou - LipioJoint 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective study of the safety and efficacy of the use of a Lipiodol Emulsion for the embolization of inflammatory hypervascularizations observed in patients with articular or abarticular pain in the knee - LipioJoint 1
    Étude prospective de sécurité et d'efficacité d'utilisation d'une émulsion de Lipiodol pour l'embolisation des hypervascularisations inflammatoires observées chez des patients ayant des douleurs articulaires ou abarticulaires du genou - LipioJoint 1
    A.3.2Name or abbreviated title of the trial where available
    LipioJoint 1
    LipioJoint 1
    A.4.1Sponsor's protocol code numberAPHP190891
    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 - HOPITAUX DE PARIS (AP-HP)
    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 supportASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number0144 84 17 22
    B.5.5Fax number0144 84 17 01
    B.5.6E-mailkarine.goude@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 Yes
    D.2.1.1.1Trade name LIPIODOL ULTRA FLUIDE 480 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderGUERBET
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    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.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 Optiray 300 (300 mg I/mL)
    D.2.1.1.2Name of the Marketing Authorisation holderGuerbet
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    Intraarterial use
    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
    Adult patients with articular or abarticular intractable pain in the knee
    Patients majeurs souffrant de douleurs articulaires ou abarticulaires du genou réfractaires aux traitements conventionnels
    E.1.1.1Medical condition in easily understood language
    Adult patients with articular or abarticular intractable pain in the knee
    Patients majeurs souffrant de douleurs articulaires ou abarticulaires du genou réfractaires aux traitements conventionnels
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    Describe the safety of using a Lipiodol emulsion® for the embolization of inflammatory hypervascularizations in patients with articular or abarticular intractable pain in the knee.
    Décrire la sécurité d’utilisation d’une émulsion de Lipiodol® pour l’embolisation de l’hypervascularisation inflammatoire chez des patients atteints de douleurs articulaires ou abarticulaires du genou réfractaires aux traitements traditionnels.
    E.2.2Secondary objectives of the trial
    Describe the efficacy of using a Lipiodol emulsion® for the embolization of inflammatory hypervascularizations in patients with articular or abarticular intractable pain in the knee.
    Décrire l’efficacité d’utilisation d’une émulsion de Lipiodol® pour l’embolisation de l’hypervascularisation inflammatoire chez des patients atteints de douleurs articulaires ou abarticulaires du genou réfractaires aux traitements traditionnels.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -age between 18 and 90 years included
    -diagnosis of primary inflammatory knee osteoarthritis defined by an osteoarthritis according to the classification of the ACR (American College of Rheumatology) and a score ≥ 2 according to the classification of Kellgren and Lawrence
    -patient not eligible for surgery (or refusing surgery)
    -pain ≥ 40 mm (Analog Visual Scale) despite an analgesic medication for at least 3 months
    -failure or intolerance of treatment with NSAIDs and/or tramadol and/or paracetamol, and/or failure or intolerance or patient unwilling a strong opioid treatment (morphinic, codeine)
    -failure or refusal by the patient of corticosteroid infiltration
    -patient who has signed an informed consent
    -âge compris entre 18 et 90 ans inclus
    -diagnostic de gonarthrose inflammatoire primaire de l’articulation cible défini par une gonarthrose selon la classification de l’ACR (American College of Rheumatology) et un score ≥ 2 selon la classification de Kellgren et Lawrence
    -patient non éligible à la chirurgie (ou refusant la chirurgie)
    -douleur ≥ 40 mm (Echelle Visuelle Analogique) malgré un traitement analgésique depuis au moins 3 mois
    -échec ou intolérance d'un traitement par AINS et/ou tramadol et/ou paracétamol, et/ou échec ou intolérance ou patient ne souhaitant pas un traitement par opioïdes fort (morphinique, codéine)
    -échec ou refus par le patient de l'infiltration de corticoïdes
    -patient ayant signé un consentement éclairé
    E.4Principal exclusion criteria
    -patient unable or unwilling to comply with the follow-up schedule
    -infiltration in target joint within the previous three months
    - treated hyperthyroidism
    -traumatic injury, hemorrhage or bleeding in the target joint within the last week
    -known severe allergy to Lipiodol® and/or iodized contrast medium
    -known severe kidney failure (creatinine clearance < 30 ml/min)
    -pregnant or breastfeeding woman
    -patient not affiliated with a French medicare
    -patient benefiting from legal protection
    -participation in another interventional study
    -patient incapable ou ne souhaitant pas se conformer au calendrier de suivi
    -infiltration de l’articulation cible datant de moins de trois mois
    -hyperthyroïdie traitée
    -lésion traumatique, hémorragie ou saignement datant de moins de 1 semaine dans l’articulation cible
    -allergie grave connue au Lipiodol® et/ou au produit de contraste iodé
    -insuffisance rénale sévère connue (clairance à la créatinine < 30 ml/min)
    -grossesse, allaitement
    -patient non affilié à un régime de sécurité sociale français
    -patient bénéficiant d’une mise sous protection juridique (tutelle, curatelle, etc.)
    -participation à une autre recherche interventionnelle
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the number of Serious Adverse Events imputable to embolization.
    Le critère d'évaluation principal est le nombre d’Evènements Indésirables Graves imputables à l’embolisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month
    1 mois
    E.5.2Secondary end point(s)
    The secondary endpoints are the folowing : immediate technical success, reduction of pain score (Analog Visual Scale), improvement of joint disability score (WOMAC), improvement of quality of life score (SF-36), reduction of pain medication, patient satisfaction by questionnaire, adverse events and serious adverse events up to 3 months after embolization.
    Les paramètres secondaires sont les suivants : succès technique immédiat, réduction du score de douleur (Echelle Visuelle Analogique), amélioration du score d’invalidité articulaire (WOMAC), amélioration du score de qualité de vie (SF-36), réduction de la thérapie analgésique, satisfaction du patient par questionnaire, évènements indésirables et évènements indésirables graves jusqu’à 3 mois après l’embolisation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    3 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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 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
    LVSL
    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 months27
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 No
    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 state22
    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)
    None
    Aucun
    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 Decision2020-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-20
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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