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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-003939-38
    Sponsor's Protocol Code Number:P160404J
    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:2017-06-15
    Trial results View 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 number2016-003939-38
    A.3Full title of the trial
    Short-term efficacy of a single ultrasound-guided intra-articular injection of botulinum toxin A associated with splinting for base-of-thumb osteoarthritis on pain at 3 months: A randomized placebo-controlled pilot study
    Efficacité à court terme d’une injection intra-articulaire échoguidée de toxine botulinique associée au port d’une orthèse sur mesure dans la rhizarthrose : étude-pilote randomisée contrôlée en double-aveugle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Short-term efficacy of a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting for base-of-thumb osteoarthritis on pain at 3 months
    Efficacité à court terme d'une injection intra-articulaire échoguidée de toxine botulinique associée au port d'une orthèse sur mesure dans la rhizarthrose
    A.3.2Name or abbreviated title of the trial where available
    RHIBOT
    A.4.1Sponsor's protocol code numberP160404J
    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 supportAP-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.5.6E-mailjosephine.braun@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 BOTOX
    D.2.1.1.2Name of the Marketing Authorisation holderALLERGAN FRANCE
    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 nameBOTOX
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNToxine botulinique de type A
    D.3.9.3Other descriptive nameToxine botulinique A
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50 U Allergan
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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 placeboSolution for injection
    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
    Patients referred to our Physical Medicine Rehabilitation Department of a tertiary care center in Paris, France, for the management of Base-of-thumb osteoarthritis (BTOA)
    Patients de consultation et d'hospitalisation du Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis répondant aux critères de classification de l'American College of Rheumatology pour la rhizarthrose
    E.1.1.1Medical condition in easily understood language
    Patients referred for the management of base-of-thumb osteoarthritis
    Patients répondant aux critères de classification de l'American College of Rheumatology pour la 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
    To compare the efficacy on pain at 3 months of a single ultrasound-guided intra-articular injection of (botulinum toxin A) BTA associated with splinting to a single ultrasound-guided intra-articular injection of saline associated with splinting in patients with painful Base-of-thumb osteoarthritis (BTOA)
    Comparer l'efficacité sur la douleur d'une infiltration intra-articulaire échoguidée de toxine botulinique associée au port d'une orthèse sur mesure par rapport à une infiltration échoguidée du même volume de sérum physiologique associée au port d'une orthèse sur mesure dans la rhizarthrose à 3 mois après l'infiltration
    E.2.2Secondary objectives of the trial
    To compare the efficacy of a single ultrasound-guided intra-articular injection of BTA associated to splinting to a single ultrasound-guided intra-articular injection of saline associated to splinting in patients with BTOA on pain at 1 and 6 months and hand-specific limitations in activities at 3 and 6 months.
    Data regarding co-interventions and safety will be collected at 1, 3 and 6 months.
    Comparer l'efficacité sur la douleur à 1 et 6 mois, la fonction, l'évaluation globale par le patient, le pourcentage de répondeurs Osteoarthritis Research Society International (OARSI) et les co-interventions à 3 et 6 mois d'une infiltration intra-articulaire échoguidée de toxine botulinique associée au port d'une orthèse sur mesure par rapport à une infiltration échoguidée du même volume de sérum physiologique associée au port d'une orthèse sur mesure dans la rhizarthrose.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient aged >/= 18 years
    Symptoms involving the base-of-thumb
    Mean base-of-thumb pain intensity in the previous 48 hours on NRS >/= 30
    Radiographic evidence of at least 2 of 4 radiographic items: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts
    Physical examination findings consistent with BTOA
    Written consent
    Health cover
    - Patients âgés de 18 ans ou plus
    - Douleur >/= 30 sur une EN
    - Symptômes douloureux intéressant la base du pouce
    - Rhizarthrose radiologique (2/4 items intéressant l'articulation trapézo-métacarpienne : ostéophytes, pincement, condensation ou géodes)
    - Critères de l'ACR de 1990 pour l'arthrose de la main adaptés à la rhizarthrose
    - Examen médical préalable
    - Consentement écrit
    - Affiliation à un régime de Sécurité Sociale
    E.4Principal exclusion criteria
    - History of thumb surgery
    - History of inflammatory or crystal-associated rheumatic disease involving the hands
    - Neurological disorders involving the hands
    - Collagen disorders involving the hands : Dupuytren, Marfan or Ehlers-Danlos diseases
    - Ostearthritis affecting the scaphotrapezial joint
    - Hand or wrist trauma </= 2 months
    - Hand or wrist intra-articular injections </= 2 months
    - Contra-indications to BTA injections or splinting
    - Cognitive or behavioral disorders making the assessment impossible
    - Inability to speak or write French
    - Bilateral rhizarthrosis without dominant affected site
    - Pregnancy and breast feeding
    - Antécédents de chirurgie du pouce
    - Antécédents de rhumatisme inflammatoire ou microcristallin
    - Affections neurologiques touchant la main
    - Affections du collagène touchant la main : maladies de Dupuytren, Marfan ou Ehlers-Danlos
    - Arthrose scapho-trapézienne
    - Traumatisme de la main ou du poignet </= 2 mois
    - Infiltration intra-articulaire de la main ou du poignett </= 2 mois
    - Contre-indications à la réalisation d'injection de toxine botulinique ou au port d'une orthèse
    - Troubles cognitifs ou du comportement rendant impossible l'évaluation
    - Troubles de la compréhension et d'expression de la langue française
    - Rhizarthrose bilatérale sans côté douloureux prédominant
    - Grossesse et allaitement
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome
    - Mean base-of-thumb pain intensity in the previous 48 hours on an 11-point numeric rating scale (NRS, 0 = no pain, 100 = maximal pain) at 3 months

    Secondary outcomes
    - Mean base-of-thumb pain intensity in the previous 48 hours on NRS at 1 and 6 months, compared to inclusion.
    - Hand-specific limitations in activities, compared to inclusion, on Cochin Hand Function Scale (CHFS, 0 = no limitations in activities, 90 = maximal limitations in activities) at 3 and 6 months : Ref Poiraudeau S. et al., Osteoarthritis Cartilage. 2001(6):570-7.
    - Patient self assessment of health improvement.
    - Analgesics and non-steroidal anti-inflammatory drugs consumption at 1, 3 and 6 months
    Le critère de jugement principal est la réduction de la douleur moyenne au cours des 48 dernières heures par rapport à l'inclusion, sur une échelle numérique (EN) auto-administrée à 11 classes (0 = absence de douleur, 100 = douleur maximale) à 3 mois après l'infiltration.

    Les critères de jugement secondaires sont :
    - la réduction de la douleur moyenne au cours des 48 dernières heures par rapport à l'inclusion sur une EN auto-administrée à 11 classes à 1 et 6 mois après l'infiltration.
    - la réduction des limitations d'activités par rapport à l'inclusion sur l'échelle auto-administrée de la main de Cochin (CHFS, 0 = pas de limitation, 90 = limitation maximale) à 3 et 6 mois après l'infiltration.
    - l'amélioration de l'état de santé global évalué par le patient par rapport à l'inclusion sur une EN auto-administrée à 11 classes (0 le pire possible - 100 le meilleur possible) à 3 et 6 mois après l'infiltration.
    - le pourcentage de répondeurs OARSI à 3 et 6 mois après l'infiltration : la réponse est définie comme l'amélioration de la douleur (évaluée sur une EN, 0 à 100) ou de la fonction (évaluée sur l'échelle CHFS, 0 à 90) >/= 50% et une variation absolue respectivement >/= 20/100 ou >/= 9/90 ou l'amélioration de 2 des 3 items suivants : 1/ douleur >/= 20% et variation absolue >/= 10/100, 2/ fonction >/= 20% et variation absolue >/= 9/90, 3/ évaluation globale par le patient (évaluée sur une EN, 0 à 100) >/= 20% et variation absolue >/= 10/100.
    - la consommation d'antalgiques (paliers 1, 2 ou 3) depuis le dernier contact sur une échelle auto-administrée à 4 classes (jamais, plusieurs fois par mois, plusieurs fois par semaine, tous les jours) à 3 et 6 mois après l'infiltration.
    - la consommation d'anti-inflammatoires non stéroïdiens depuis le dernier contact sur une échelle auto-administrée à 4 classes (jamais, plusieurs fois par mois, plusieurs fois par semaine, tous les jours) à 3 et 6 mois après l'infiltration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 3 months
    A 3 mois
    E.5.2Secondary end point(s)
    Secondary outcomes
    - Mean base-of-thumb pain intensity in the previous 48 hours on NRS at 1 and 6 months
    - Hand-specific limitations in activities on Cochin Hand Function Scale (CHFS, 0 = no limitations in activities, 90 = maximal limitations in activities) at 3 and 6 months : Ref Poiraudeau S. et al., Osteoarthritis Cartilage. 2001(6):570-7.
    - Analgesics and non-steroidal anti-inflammatory drugs consumption at 1, 3 and 6 months
    - Total knee replacement at 1, 3 and 6 months
    Les critères de jugement secondaires sont :
    - la réduction de la douleur à 1 et 6 mois sur une EN
    - la réduction des limitations d'activité à 3 et 6 mois sur l'échelle de la main de Cochin (CHFS, 0 = pas de limitation, 90 = limitation maximale)
    - les effets indésirables rapportés à 1, 3 et 6 mois
    - la consommation rapportée d'antalgiques et d'anti-inflammatoires et le recours à une chirurgie à 3 et 6 mois
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 1, 3 and 6 months
    A 1, 3 et 6 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) 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 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
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 Yes
    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
    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)
    Normal treatment of this condition
    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 Decision2017-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-23
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