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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7259   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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    EudraCT Number:2009-017443-34
    Sponsor's Protocol Code Number:NA22823
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-09-28
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-017443-34
    A.3Full title of the trial
    A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naìve to TNF antagonist therapy
    Studio di fase II/III senza interruzione tra le fasi, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare la riduzione dei segni e dei sintomi e l`inibizione del danno strutturale durante il trattamento con tocilizumab rispetto al placebo in pazienti affetti da spondilite anchilosante, che non hanno risposto alla terapia con farmaci antinfiammatori non steroidei e che sono nuovi al trattamento con anti-TNF
    A.4.1Sponsor's protocol code numberNA22823
    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 SponsorF. Hoffmann-La Roche Ltd.
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 RoActemra
    D. 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 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number200
    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. 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 Yes
    D. medicinal product typeanticorpo monoclonale umanizzato recettore dell'interleuchina 6 (IL-6)
    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
    Ankylosing Spondylitis
    Spondilite anchilosante
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess: - Efficacy of treatment with TCZ 4 mg/kg and 8 mg/kg versus placebo in AS patients who are naìve to treatment with TNF antagonist therapy with regard to the proportion of patients who achieve an ASAS20 response at week 12 (confirmation at week 24) -Safety of TCZ 4 mg/kg and 8 mg/kg versus placebo with regard to AEs and laboratory assessments
    Valutare: - Efficacia del trattamento con TCZ 4 mg/kg e 8 mg/kg rispetto al placebo in pazienti affetti da spondilite anchilosante (SA), nuovi al trattamento con terapia anti-TNF, in termini di percentuale di pazienti che conseguono una risposta ASAS20 alla settimana 12 (conferma alla settimana 24) - Sicurezza di TCZ 4 mg/kg e 8 mg/kg rispetto al placebo, in termini di eventi avversi e valutazioni di laboratorio
    E.2.2Secondary objectives of the trial
    To assess: - Efficacy of treatment with regard to radiographic benefit and improvement of physical function over 104 weeks - Long term safety and efficacy of TCZ in patients with AS - Pharmacokinetics and pharmacodynamics of TCZ in patients with AS - Immunogenicity of TCZ in patients with AS
    Valutare:- Efficacia del trattamento in termini di benefici radiografici e miglioramento della funzionalita` fisica nell`arco di 104 settimane- Sicurezza ed efficacia a lungo termine di TCZ in pazienti affetti da SA- Farmacocinetica e farmacodinamica di TCZ in pazienti affetti da SA- Immunogenicita` di TCZ in pazienti affetti da SA
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Titolo:Studio di fase II/III senza interruzione tra le fasi, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare la riduzione dei segni e dei sintomi e l'inibizione del danno strutturale durante il trattamento con tocilizumab rispetto al placebo in pazienti affetti da spondilite anchilosante, che non hanno risposto alla terapia con farmaci antinfiammatori non steroidei e che sono nuovi al trattamento con anti-TNF
    Obiettivi:1. Sottostudio di farmacocinetica e farmacodinamica con campionamento intensivo nella Parte 1 (in un sottogruppo di circa 30 pazienti, 15 pazienti per ogni gruppo di trattamento) il cui obiettivo e' calcolare i parametri farmacocinetici in seguito a una singola infusione di TCZ.
    2.sottostudio di farmacocinetica con campionamento intensivo nella Parte 2 (sottogruppo di circa 45 pazienti, 15 pazienti per ogni gruppo di trattamento) il cui obiettivo e' calcolare i parametri farmacocinetici allo steady-state.

    E.3Principal inclusion criteria
    - adult patients, >/=18 years of age - diagnosis of definite ankylosing spondylitis, defined by modified New York criteria, `‰¥ 3 months prior to baseline - active disease defined as BASDAI score of `‰¥ 4.0 and spinal pain assessment score of `‰¥40, on a 0-100 mm Visual Analogue Scale (VAS), at screening and baseline - inadequate response or intolerant to 1 or more current or previous NSAIDs
    - Uomini e donne di eta` `‰¥18 anni, - Diagnosi di SA in base ai criteri di New York modificati emessa da `‰¥3 mesi prima della visita basale - Malattia attiva definita da BASDAI `‰¥4,0 e dolore spinale `‰¥40 su una scala analogica visiva (VAS) compresa tra 0 e 100 mm allo screening e alla visita basale - Risposta inadeguata (RI) o intolleranza ad una o piu` terapie correnti o precedenti con FANS
    E.4Principal exclusion criteria
    - previous treatment with tocilizumab - previous treatment with TNF antagonist therapy - inflammatory rheumatic disease other than AS (psoriatic arthritis is allowed if patient also has definite AS as defined in inclusion criteria) - active, acute uveitis at baseline - major surgery (including joint surgery) within eight weeks prior to screening or planned major surgery within six month after randomisation
    - Pazienti precedentemente trattati con Tocilizumab. - pazienti precedentemente trattati con una terapia con anti-TNF. - Malattia infiammatoria reumatica diversa da AS (l`artrite psoriasica e` permessa se il paziente ha anche una AS definita come nei criteri di inclusione). - Attiva, acuta uveite alla visita basale. - Operazioni significative(incluse operazioni alle articolazioni) avvenute entro otto settimane prima dello screening o pianificate entro sei mesi dopo la randomizzazione.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in part 1 and part 2 is the proportion of patients with an ASAS 20 response at week 12.
    L'endpoint primario sia nella parte 1 che nella parte 2 e' la percentuale di pazienti che conseguono una risposta ASAS40 alla settimana 12.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    analisi dei biomarcatori ossei; biomarcatori esplorativi (DNA e non-DNS); test immunogenetici
    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) 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 263
    F.4.2.2In the whole clinical trial 502
    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 Decision2010-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-07-15
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