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    Summary
    EudraCT Number:2012-002760-27
    Sponsor's Protocol Code Number:CAIN457F2309E1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-002760-27
    A.3Full title of the trial
    A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis
    Studio di estensione della durata di 4 anni per valutare il profilo di efficacia, sicurezza e tollerabilita' di secukinumab in pazienti affetti da artrite reumatoide attiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis.
    Studio di estensione di 4 anni per valutare l'efficacia, la sicurezza e la tollerabilità a lungo termine di secukinumab in pazienti con artrite reumatoide attiva.
    A.4.1Sponsor's protocol code numberCAIN457F2309E1
    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 SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    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 supportNOVARTIS
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 96541
    B.5.5Fax number+39 02 9659066
    B.5.6E-mailinfo.studiclinici@novartis.com
    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 No
    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 namesecukinumab
    D.3.2Product code AIN457
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSECUKINUMAB
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    D.3.9.4EV Substance CodeSUB33242
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 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.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 No
    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 namesecukinumab
    D.3.2Product code AIN457
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSECUKINUMAB
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    D.3.9.4EV Substance CodeSUB33242
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid arthritis
    Artrite reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    Artrite reumatoide
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10037738
    E.1.2Term R arthritis
    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 evaluate the long-term efficacy of secukinumab with respect to ACR20, ACR50 and ACR70 response over time up to Month 60 in patients who completed the phase III study CAIN457F2309
    Valutare l’efficacia a lungo termine di due differenti dosaggi di secukinumab (somministrato in formulazione liquida tramite siringa pre-riempita) nel raggiungimento dei parametri ACR20, ACR50 e ACR70 fino al mese 60 in pazienti con artrite reumatoide attiva con risposta inadeguata od intolleranti ad agenti anti-TNF╬▒, e che avevano completato lo studio di fase 3 CAIN457F2309.
    E.2.2Secondary objectives of the trial
    1) To evaluate the long-term efficacy of secukinumab with respect to changes in HAQ-DI relative to baseline over time up to Month 60 2) To evaluate the long-term efficacy of secukinumab with respect to the proportion of subjects achieving major clinical response (continuous sixmonth period of ACR70 response) over time up to Month 60 3) To evaluate the long-term efficacy of secukinumab with respect to the changes in DAS28 relative to baseline over time up to Month 60
    1. Valutare l’efficacia a lungo termine di due differenti dosaggi di secukinumab in merito alle variazioni del HAQ-DI rispetto al basale fino al mese 60. 2. Valutare l’efficacia a lungo termine di due differenti dosaggi di secukinumab rispetto alla proporzione di pazienti che hanno raggiunto la risposta clinica maggiore (risposta ACR70 mantenuta per 6 mesi) fino al mese 60. 3. Valutare l’efficacia a lungo termine di due differenti dosaggi di secukinumab in merito alle variazioni del DAS28 rispetto al basale fino al mese 60 4. Valutare l’efficacia a lungo termine di due differenti dosaggi di secukinumab rispetto alla proporzione di pazienti che hanno raggiunto una bassa attività di malattia (DAS28≤3.2) e una risposta EULAR buona/moderata fino al mese 60 5. PER FAVORE VEDERE SINOSSI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Subjects who provide a written, signed and dated informed consent before any study assessment is performed 2) Subjects must have participated in phase III study CAIN457F2309, must have completed the entire treatment period and must have received secukinumab during phase III study (either from start of phase III study or after re-assignment to one of the secukinumab arms after week 16/24) 3) Subjects who are deemed by the investigator to benefit from continued secukinumab therapy
    1. I soggetti devono essere capaci di capire e comunicare con lo sperimentatore, devono ottemperare alle richieste dello studio e devono fornire un consenso informato scritto, firmato e datato prima che qualsiasi valutazione sia effettuata 2. I soggetti devono aver partecipato allo studio di fase 3 CAIN457F2309, devono aver completato l’intero periodo di trattamento e devono aver ricevuto secukinumab (a partire dall’inizio, o dopo la riallocazione ad uno dei bracci con di trattamento dopo la settimana 16/24) 3. I soggetti che secondo il giudizio dell’investigatore possano trarre beneficio dalla prosecuzione della terapia con secukinumab
    E.4Principal exclusion criteria
    1) Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab 2) Any subject who is deemed not to be benefiting from the study drug based upon lack of improvement or worsening of their symptoms 3) Any subject who continued to receive abatacept after week 16 during the phase III study CAIN457F2309 Other protocol-defined exclusion criteria may apply
    I soggetti che soddisfano qualsiasi dei seguenti criteri non sono eleggibili per l’inclusione in questo studio. 1. Qualsiasi soggetto che assume in concomitanza agente/i biologico/i immunomodulante/i ad eccezione di secukinumab 2. Qualsiasi soggetto che non possa trarre beneficio dal farmaco in studio basandosi sulla mancanza di miglioramento o sul peggioramento dei sintomi 3. Qualsiasi soggetto che ha continuato a ricevere abatacept dopo la settimana 16 durante lo studio di fase 3 CAIN457F2309 4. Donne gravide oppure che stanno allattando, dove la gravidanza è definita come lo stato di una donna dal concepimento fino al termine della gestazione, confermata da un test di laboratorio positivo per hCG (&gt;10 mIU/mL) 5. Donne in età fertile, definite come tutte le donne psicologicamente in grado di intraprendere una gravidanza, che non desiderino utilizzare metodi di contraccezione efficaci durante lo studio e per 16 settimane dopo il termine del trattamento.
    E.5 End points
    E.5.1Primary end point(s)
    ACR 20, 50 and 70
    ACR 20, 50 e 70
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over the entire duration of the study up to Month 60
    Copre l'intera durata dello studio fino al mese 60
    E.5.2Secondary end point(s)
    1) Questionnaire Disability Index (HAQ-DI) 2) Major clinical response 3) DAS28
    1) Questionnaire Disability Index (HAQ-DI) 2) Major clinical response 3) DAS28
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over the entire duration of the study up to Month 60
    Copre l'intera durata dello studio fino al mese 60
    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 No
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Immunizzazione
    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 Yes
    E.8.1.7.1Other trial design description
    double-dummy (doppio fantasma)
    double-dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    no placebo e no farmaco di confronto - Stesso farmaco ad altro dosaggio
    no placebo or active control group - same IMP used at different dosage
    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 EEA71
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Canada
    Colombia
    Mexico
    Russian Federation
    United States
    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
    LVLS
    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.1.2.1Number of subjects for this age range: 276
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 69
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 164
    F.4.2.2In the whole clinical trial 345
    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)
    The investigator must provide follow-up medical care for all subjects who leave the study, or must refer them for appropriate ongoing care. This care may include initiating another treatment outside of the study as deemed appropriate by the investigator. This treatment may be any non-biologic DMARD. In case of a biologic treatment, a waiting period of 3 months before initiating the treatment is recommended
    Il ricercatore deve fornire l'assistenza medica necessaria a tutti i pazienti che lasciano lo studio, o devono farli riferimento per la terapia più appropriata. Questa terapia può comprendere l'inizio di un altro trattamento al di fuori dello studio come ritenuto più appropriato dal ricercatore. Questo trattamento potrebbe essere DMARD non biologico ma in caso di trattamento biologico é raccomandato un periodo di attesa di 3 mesi prima dell'inizio del nuovo trattamento.
    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 Decision2012-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-07
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