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    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-001027-20
    Sponsor's Protocol Code Number:CACZ885GDE01T
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-12-05
    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 ConcernedGermany - PEI
    A.2EudraCT number2011-001027-20
    A.3Full title of the trial
    A Multi-Centre, Placebo-Controlled Phase II Study of Canakinumab for the Treatment of Adult-onset Still's disease (AOSD) including an open-label long term extension.
    Eine multizentrische, Plazebo-kontrollierte Phase II-Studie mit Canakinumab zur Behandlung des Still-Syndroms des Erwachsenen inklusive einer Verlängerungsphase ohne Plazebokontrolle.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multi-Centre, Placebo-Controlled Phase II Study of Canakinumab for the Treatment of Adult-onset Still's disease (AOSD) including an open-label long term extension.
    Eine multizentrische, Plazebo-kontrollierte Phase II-Studie mit Canakinumab zur Behandlung des Still-Syndroms des Erwachsenen inklusive einer Verlängerungsphase ohne Plazebokontrolle.
    A.3.2Name or abbreviated title of the trial where available
    CONSIDER
    A.4.1Sponsor's protocol code numberCACZ885GDE01T
    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 SponsorCharité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointJan Zernicke
    B.5.3 Address:
    B.5.3.1Street AddressChariteplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930450513227
    B.5.5Fax number+4930450513986
    B.5.6E-mailjan.zernicke@charite.de
    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 Ilaris
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCanakinumab
    D.3.2Product code EU/1/09/564/004
    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 INNCANAKINUMAB
    D.3.9.1CAS number 914613-48-2
    D.3.9.2Current sponsor codeACZ885
    D.3.9.4EV Substance CodeSUB30137
    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 RoleComparator
    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 Ilaris
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCanakinumab
    D.3.2Product code EU/1/09/564/004
    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 INNCANAKINUMAB
    D.3.9.1CAS number 914613-48-2
    D.3.9.2Current sponsor codeACZ885
    D.3.9.4EV Substance CodeSUB30137
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    adult onset Still's disease (AOSD)
    Still Syndrom des Erwachsenen
    E.1.1.1Medical condition in easily understood language
    adult onset Still's disease (AOSD)
    Still Syndrom des Erwachsenen
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10042061
    E.1.2Term Still's disease
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to assess efficacy of Canakinumab treatment for patients with adult onset Still's disease (AOSD) and active joint involvement according to proportion of patients with significant reduction of disease activity (DAS 28 [>1,2]) after 12 week treatment period

    Evaluation of the long-term safety of canakinumab in patients with AOSD and articular involvement
    E.2.2Secondary objectives of the trial
    evaluation of safety of Canakinumab for patients with adult onset Still's
    disease (AOSD)

    evaluation of efficacy of Canakinumab for patients with AOSD and joint involvement according ACR response criteria at week 12 and week 24

    proportion of patients who achieve a low disease activity (DAS28 < 3,2) or remission (DAS28 < 2,6)

    documentation of change in joint mobility

    to assess change in general health status using HAQ-DI and SF36-questionaire

    improvement of dermal Manifestation

    reduction of inflamatory lab values
    (CRP, ESR, Ferritin)

    Biomarker Analysis

    Description of the long-term efficacy of canakinumab in patients with AOSD according to EULAR response criteria (proportion of patients showing prolonged clinically improvement according to DAS28 low-disease activity [< 3.2] and remission [< 2.6], reduction of flares and glucocorticoid intake).

    Evaluation if a reduced dosage of canakinumab can be used to control disease activity
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ° sub-study is integrated in main study
    protocol but with a seperate patient
    information and patient consent form
    ° title: substudy to analyse Biomarkers
    like inflammatory proteins and gene
    ° main objectives:
    - soluble proteins to assess patho-
    mechanism like IL-6 and IL-18,
    S100 as inflammtory marker
    - pharmacogenomic analysis
    - mRNA expression to assess
    relationship to macrophage
    activating syndrome
    - pharmacogenetic analyses to identify
    Single Nucleotide Polymorphism (SNP)
    E.3Principal inclusion criteria
    written informed consent

    men and women ≥ 18 years and ≤ 75 years

    diagnosis of adult onset Still's disease according Yamaguchi et al. criteria (J Rheumatology 1992)

    disease activity (DAS28 >3,2) at Screening

    joint involvement defined as minimum 4 painfull and 4 swollen joints at Screening and Baseline (28 joint count)

    if treated with NSAID's: stable treatment for a minimum of 2 weeks prior to randomisation

    if treated with corticosteroids: stable treatment for a minimum of 1 week prior to randomisation (≤ 10 mg/ day)

    if on conventional DMARD therapy: stable treatment for a minimum of 6 weeks prior to randomisation

    washout of biologic DMARD's

    effective method for contraception
    E.4Principal exclusion criteria
    prior treatment with two or more doses of IMP

    intraarticular or intravenous injection with corticosteroids 4 weeks before randomisation

    treatment with narcotic analgetics (excluding permitted concomitant medications such as Tramadol and Codein)

    diagnosis of other, severe, chronic-inflammatory diseases

    positive hepatitis B Antigen (HBsAg), hepatitis C antibody and/ or HIV-antibody

    relevant active infection

    positive screening for latent tuberculosis (if patient is taking adequate/isoniazid prophylaxis for 4 weeks before first IP administration, this patient may be randomized.)

    elevated lab results: AST, ALT Bilirubin, Creatinine

    non adequate hematologic lab result

    history of neoplasm (with exception of curative treated non-melanoma neoplasm of the skin and carcinoma in situ of cervix)

    relevant cardial or pulmonary diseases

    macrophage activating syndrome (MAS)

    vaccination with life vaccine

    a history of alcohol or drug abuse within last 12 months

    blood donation or blood loss ≥ 400 ml within last 8 weeks

    pregnancy or breastfeeding
    E.5 End points
    E.5.1Primary end point(s)
    Disease activity score 28 Joints (DAS28)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at Screening, Baseline and at week 12
    E.5.2Secondary end point(s)
    Joint manifestation:
    1.DAS28 (Disease activity score)
    2.ACR (American College of Rheumatology) Response Criteria and EULAR response criteria for low disease activity (DAS28 < 3.2) and remission (DAS28 < 2,6)

    Assessment of the level of disability and of quality of life:
    1.Health Assessment Questionnaire Disability Index (HAQ-DI)
    2.SF-36 health Survey

    Laboratory tests
    1.Serological markers for inflammatory reactions (CRP, ESR, ferritin)
    2.Immunogenity (anti-canakinumab antibodies) will be established at all visits, in the case of episodes of illness and with MAS. In the event of an anaphylactic reaction occurring, samples will be investigated following the injection and at intervals of 8 weeks.
    E.5.2.1Timepoint(s) of evaluation of this end point
    core-study: week 0, 4, 8, 12, 16, 20 and week 24

    in long term extension phase (LTE): every 3 months (quarterly) up to visit month 30

    safety evaluation (= secondary objective of core study and primary objective of LTE-phase): every month up to month 33
    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 Yes
    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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    rescue therapy with open treatment in non-responders at week 12 and a 2 y. extension phase
    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 concerned14
    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
    normally: LVLS

    exceptions: patients withdrawing consent, adverse events wich do not allow continuation of this trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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: 48
    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 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 state68
    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)
    after early discontinuation or week 24 visit (EOS) patients will get two options: referral to a rheumatologist (outpatient care) or to remain in the hands of treating physician (rheumatologist) during the trial
    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 Decision2012-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-05-04
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