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    Summary
    EudraCT Number:2020-002127-10
    Sponsor's Protocol Code Number:19-AOI-11
    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:2020-06-15
    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 number2020-002127-10
    A.3Full title of the trial
    Evaluation of pain after intra-articular injections of botulinum toxin in carpometacarpal osteoarthritis of the thumb
    Évaluation de la douleur après injections intra-articulaires de toxine botulique dans l'arthrose carpométacarpienne du pouce
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of pain after intra-articular injections of botulinum toxin in carpometacarpal osteoarthritis of the thumb
    Évaluation de la douleur après injections intra-articulaires de toxine botulique dans l'arthrose carpométacarpienne du pouce
    A.4.1Sponsor's protocol code number19-AOI-11
    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 SponsorCHU de Nice
    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 supportCHU de Nice
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nice
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address4 Avenue Reine Victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06003
    B.5.3.4CountryFrance
    B.5.4Telephone number33492034011
    B.5.5Fax number33492034575
    B.5.6E-maildrc@chu-nice.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 XEOMIN 50
    D.2.1.1.2Name of the Marketing Authorisation holderMERZ PHARMACEUTICALS GMBH
    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.3.1Product nameXEOMIN 50
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntraarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rhizarthrosis
    Rhizarthrose
    E.1.1.1Medical condition in easily understood language
    Rhizarthrosis
    Rhizarthrose
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10062893
    E.1.2Term Rhizarthrosis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine that the botulinum toxin injection is better than the placebo injection to improve pain in symptomatic trapeziometacarpal osteoarthritis at 3 months
    Montrer que l’injection de toxine botulinique est supérieure à l’injection de placebo pour améliorer la douleur dans l’arthrose symptomatique trapezo-metacarpienne à 3 mois
    E.2.2Secondary objectives of the trial
    - Determine that the effects of a trapeziometacarpal injection of TB are superior to placebo on function (Dreiser test, Kapandji index, Jamar Hydraulic Pinch Gauge), quality of sleep and quality of life at M3
    - Evaluate the tolerance of TB in rizarthrosis
    - Determine that the effects of a trapezo-metacarpal injection of TB are superior to placebo on rhizarthrosis pain at 8 weeks (8 weeks = M1.5) (telephone interview)
    - Determine that TB injection reduces the consumption of analgesic and anti-inflammatory drugs over the study period (placebo vs TB period)
    - Montrer que les effets d’une injection trapezo-metacarpienne de TB sont supérieurs au placebo sur la fonction (Dreiser test, indice de Kapandji, Jamar Hydraulic Pinch Gauge), la qualité du sommeil et la qualité de vie à M3
    - Evaluer la tolérance de la TB dans la rizarthrose
    - Montrer que les effets d’une injection trapezo-metacarpienne de TB sont supérieurs au placebo sur la douleur de rhizarthrose à 8 semaines (8 semaines = M1.5) (interrogatoire téléphonique)
    - Montrer que l’injection de TB permet de diminuer la consommation de médicaments antalgiques et anti inflammatoires sur la période de l’étude (période placebo vs TB)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient aged 18 and over
    - Patient with thumb carpometacarpal osteoarthritis objectified clinically by questionnaire and X-ray with at least 2 of the 4 following items involving the trapeziometacarpal joint : osteophytes, joint space narrowing, subchondral bone sclerosis or subchondral cysts
    - Patient giving his written consent
    - Visual analog pain scale > 4
    - Patient in failure of well-conducted drug treatment including analgesics and anti-inflammatories
    - Patients must have stopped all corticosteroid therapy or NSAIDs within the last 48 hours
    - Patient affiliated to a social security scheme
    - Patient likely to understand the instructions of the study
    - Patient >18ans
    - Patient atteint de rhizarthrose objectivée par interrogatoire, radiographie avec au moins 2 critères suivants : ostéophyte, rétrécissement de l’espace articulaire, sclérose sous chondrale ou géode
    - Patient ayant donné son consentement éclairé signé.
    - Echelle visuelle analogique (EVA) de douleur > 4
    - Echec des traitements médicamenteux bien conduits par antalgiques, anti-inflammatoires et port d’orthèse
    - Les patients devront avoir stoppé toute corticothérapie ou AINS dans les 48 dernières heures.
    - Patient affilié à un régime de Sécurité Sociale
    - Patient susceptible de comprendre les instructions de l’étude
    E.4Principal exclusion criteria
    - Patient with a history of surgery of the thumb
    - Patient who has received corticoid and others injections in the thumb carpometacarpal acid in last 6 months
    - Patient who has received a botulinum toxin injection from any site in last 3 months
    - Patient with myasthenia gravis or Lambert Eaton disease, neuromuscular dysfunction, hypersensitivity to incobotulinumtoxin A, severe breathing disorder or severe swallowing disorder
    - Patient with hypersensitivity to botulinum toxin or to any of the excipients (human albumin sucrose)
    - Patient with infection or inflammation at the injection site concerned
    - Pregnant or lactating woman (a urine pregnancy test will be performed)
    - Patient with a history of inflammatory or crystal-associated rheumatic
    - Participation in another clinical trial and at least 30 days before
    - Any medical or psychiatric condition that may prevent the proper understanding and conduct of treatment and study (major under guardianship)
    - Antécédent de chirurgie de la colonne du pouce
    - Patient ayant bénéficié d’une injection de la trapézo-métacarpienne intra-articulaire de corticoïdes, toxine botulique ou acide hyaluronique ou autre produit dans les 6 derniers mois.
    - Patient ayant bénéficié d’une injection de toxine Botulique tout site confondu depuis moins de 3 mois
    - Myasthénie ou maladie de Lambert-Eaton, dysfonctionnement neuromusculaire, hypersensibilité à incobotulinumtoxine A, trouble respiratoires sévère ou trouble déglutition sévère
    - Patient présentant une hypersensibilité à la TB ou à l'un des excipients (albumine humaine saccharose)
    - Patient présentant une infection ou inflammation au site d'injection concerné
    - Femme enceinte ou allaitante (un test de grossesse urinaire sera réalisé)
    - Patient atteint d’une pathologie inflammatoire chronique articulaire ou de pathologie microcristalline
    - Participation en cours ou de moins de 30 jours à un essai clinique médicamenteux
    - Toute condition médicale ou psychiatrique qui pourrait empêcher la bonne compréhension et la conduite du traitement et de l’étude (majeur sous tutelle)
    E.5 End points
    E.5.1Primary end point(s)
    Pain assessment at 3 months
    Evaluation de la douleur par l’EVA à 3 mois
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mois
    E.5.2Secondary end point(s)
    - Evaluation of the Dreiser test, quality of sleep and quality of life at 3 months
    - Collect side effects
    - Pain assessment at 8 weeks
    - Evaluate the use of analgesic and anti-inflammatory drugs during the study period
    - Evaluation du test de Dreiser, qualité de sommeil et qualité de vie à 3 mois
    - Recueillir les effets indésirables
    - Evaluation de la douleur par EVA à 8 semaines
    - Evaluer la prise de médicaments antalgiques et anti-inflammatoires sur la période de l’étude
    E.5.2.1Timepoint(s) of evaluation of this end point
    at least 3 months after injection
    jusqu'à 3 mois après l'injection
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months18
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state60
    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 Decision2020-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-01
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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