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    Summary
    EudraCT Number:2010-024282-41
    Sponsor's Protocol Code Number:2010.648
    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:2012-08-13
    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 number2010-024282-41
    A.3Full title of the trial
    TRAITEMENT DE LA DYSPLASIE FIBREUSE DES OS CHEZ LES PATIENTS NON REPONDEURS AUX BISPHOSPHONATES PAR LE TOCILIZUMAB. L’ESSAI TOCIDYS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TRAITEMENT DE LA DYSPLASIE FIBREUSE DES OS CHEZ LES PATIENTS NON REPONDEURS AUX BISPHOSPHONATES PAR LE TOCILIZUMAB.
    A.3.2Name or abbreviated title of the trial where available
    TOCIDYS
    A.4.1Sponsor's protocol code number2010.648
    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 SponsorHospices Civils de Lyon
    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 supportMinistère de la Santé
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpital E Herriot
    B.5.2Functional name of contact pointPr Chapurlat
    B.5.3 Address:
    B.5.3.1Street AddressPlace d’Arsonval
    B.5.3.2Town/ cityLyon
    B.5.3.4CountryFrance
    B.5.6E-mailroland.chapurlat@chu-lyon.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 RoActemra®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTocilizumab
    D.3.9.1CAS number 375823-41-9
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    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/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    dysplasie fibreuse des os
    E.1.1.1Medical condition in easily understood language
    dysplasie fibreuse des os
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10016664
    E.1.2Term Fibrous dysplasia of bone
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Démontrer que le tocilizumab réduit le niveau de résorption osseuse (évalué par le CTX sérique dosé à 6 mois de traitement) chez les patients atteints de dysplasie fibreuse des os qui ne répondent pas aux traitements par bisphosphonates.
    E.2.2Secondary objectives of the trial
    - Montrer que le traitement peut diminuer la douleur et améliorer la qualité de vie.
    - Montrer que d’autres marqueurs biochimiques osseux peuvent être affectés par le traitement (en particulier : ICTP, ostéocalcine, phosphatase alcaline osseuse, P1NP)
    - Evaluer la tolérance du traitement administré
    - Rechercher une éventuelle amélioration des images radiologiques sous traitement (radiographies du site le plus douloureux)
    -Décrire l’évolution des différents marqueurs et mesures aux différents temps.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 ans
    - Patient ayant la capacité juridique à consentir
    - Consentement éclairé signé
    - Hyperrésorption osseuse augmentée, avec un CTX sérique supérieur de 30% aux valeurs normales (le taux maximal de CTX est d’environ 620 pg/ml pour les hommes et de 780 pg/ml pour les femmes mais il varie selon l’âge ; les références sont les valeurs obtenues dans la cohorte OFELY).
    - Dysplasie fibreuse traitée pendant au moins 18 mois par un bisphosphonate avec une dose suffisante (180 mg de pamidronate IV tous les 6 mois, 30 mg/j de risedronate pendant 2 mois deux fois par an, 4 ou 5 mg d’acide zolédronique deux fois par an), mais avec une réponse insuffisante (diminution du CTX sérique de moins de 30% ou pas de réduction soutenue de la douleur osseuse)
    - Dysplasie fibreuse traitée pendant au moins 18 mois par un bisphosphonate avec une dose suffisante (180 mg de pamidronate IV tous les 6 mois, 30 mg/j de risedronate pendant 2 mois deux fois par an, 4 ou 5 mg d’acide zolédronique deux fois par an), mais qui rechute sous bisphosphonates (ré ascension du CTX sérique de plus de 30% par rapport à la normale ou réapparition de la douleur osseuse, avec EVA > 3/10 ; sachant que les CTX restent supérieurs de 30% à la valeur supérieure de la normale)
    - Test sanguin de grossesse négatif pour toutes les patientes en âge de procréer
    - Patient bénéficiaire ou affilié à un régime de sécurité sociale.
    E.4Principal exclusion criteria
    - Antécédent de maladie infectieuse qui pourrait représenter, selon l’investigateur, un risque si le patient est sous tocilizumab
    - Antécédent de toute maladie hépatique définie par une cholestase ou une cytolyse (normes du laboratoire)
    - Insuffisance rénale (créatinine clearance < 60 ml/mn)
    - Anomalie lipidique (hyperlipidémie (norme du laboratoire) non contrôlée par un traitement hypolipémiant bien conduit)
    - Antécédent d’anomalie de la formule sanguine (neutropénie, lymphopénie, thrombopénie selon les normes du laboratoire)
    - DF sans douleur osseuse
    - Femme enceinte ou qui allaite
    - Absence de contraception reconnue comme étant efficace (contraception devant être poursuivie pendant toute la durée de l’étude et 3 mois après la fin)
    - Hypersensibilité connue à la substance active ou à l’un des excipients.
    - Patients présentant une infection sévère ou active (notamment une hépatite B ou C, une infection HIV)
    E.5 End points
    E.5.1Primary end point(s)
    Dosage du marqueur CTX sérique (comparaison des moyennes des pourcentages de variation après 6 mois d’administration dans le groupe traité par rapport au groupe placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    après 6 mois d'administration du traitement
    E.5.2Secondary end point(s)
    1 - Douleur (Echelle Visuelle Ananlogique, EVA)
    2 - nombre de sites douloureux
    3 - Dosage des autres marqueurs du remodelage osseux (ICTP, ostéocalcine, phosphatase alcaline osseuse, P1NP)
    4 - échelle de qualité de vie (questionnaire SF-36)
    5 - Effets et évènements indésirables cliniques
    6 - Effets indésirables biologiques (dosages mensuels de créatinine sérique, NFS et plaquettes, ASAT, ALAT, CRP . Dosage du cholestérol et des triglycérides à l’initiation du traitement et à 8 semaines)
    7 - Recherche d'amélioration éventuelle des images radiologiques évaluées à M0, M6 et à M12 au niveau du site le plus douloureux.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Mensuellement (critères 1, 2, 3, 5, 6) ou trimestriellement (critère 4) ou tous les 6 mois (critère 7) pendant 12 mois
    A 2 mois pour le cholestérol
    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 No
    E.8.1.6Cross over Yes
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state12
    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
    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 Decision2012-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-19
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