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    Summary
    EudraCT Number:2017-004037-93
    Sponsor's Protocol Code Number:TRACE
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-07
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-004037-93
    A.3Full title of the trial
    TReat-to-tArget (T2T) with seCukinumab in axial spondyloarthritis. IdEntification of MRI and biochemical biomarkers for disease activity, treatment response and structural damage progression (the TRACE study)
    Videnskabeligt studie af behandlings-algoritme med Cosentyx til patienter med rygsøjlegigt. Identifikation af MR- og biokemiske markører for sygdomsaktivitet, behandlingsrespons og udvikling af strukturel knogleskade (TRACE studiet)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TReat-to-tArget (T2T) with seCukinumab in axial spondyloarthritis. IdEntification of MRI and biochemical biomarkers for disease activity, treatment response and structural damage progression (the TRACE study)
    Videnskabeligt studie af behandlings-algoritme med Cosentyx til patienter med rygsøjlegigt. Identifikation af MR- og biokemiske markører for sygdomsaktivitet, behandlingsrespons og udvikling af strukturel knogleskade (TRACE studiet)
    A.4.1Sponsor's protocol code numberTRACE
    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 SponsorAfdeling for Rygkirurgi, Led- og Bindevævssygdomme ; Rigshospitalet - Glostrup
    B.1.3.4CountryDenmark
    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 Healthcare A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVidencenter for Reumatologi og Rygsygdomme, Rigshospitalet
    B.5.2Functional name of contact pointInformation desk at entrance 5
    B.5.3 Address:
    B.5.3.1Street AddressValdemar Hansens Vej 17
    B.5.3.2Town/ cityGlostrup
    B.5.3.3Post code2600
    B.5.3.4CountryDenmark
    B.5.6E-mailmo@dadlnet.dk
    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 Cosentyx
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Healthcare A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameCosentyx
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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.3.9.3Other descriptive nameSECUKINUMAB
    D.3.9.4EV Substance CodeSUB33242
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 300
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Axial spondyloarthritis and ankylosing spondylitis
    E.1.1.1Medical condition in easily understood language
    Axial spondyloarthritis and ankylosing spondylitis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    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 reductions in MRI inflammation in the SIJs and spine from week 16 to 24 in patients who at week 16 are in ASDAS remission (defined as ASDAS inactive disease i.e. ASDAS<1.3) (i.e. continue sc. secukinumab 150 mg monthly) vs. not in ASDAS remission (i.e. increase sc. secukinumab 300 mg monthly).
    E.2.2Secondary objectives of the trial
    Several objectives, among others:

    To compare changes in ASDAS and in MRI inflammation in the SIJs and spine from week 16 to 24 in patients who at week 16 are in ASDAS remission (i.e. continue sc. secukinumab 150 mg monthly) vs. not in ASDAS remission (i.e. increase to sc. secukinumab 300 mg monthly).

    To compare changes in ASDAS and in MRI inflammation in the SIJs and spine from week 0 to 16 in patients who at week 16 are in ASDAS remission vs. not in ASDAS remission.

    To describe the temporal changes on cMRI in MRI inflammation and structural lesions in the SIJs and spine from week 0 to week 56 in patients treated with secukinumab (cf. “treatment arms”).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Diagnosis of axSpA according to the ASAS criteria and/or AS according to the modified New York criteria as judged by a SpA rheumatologist (regarding imaging in the criteria, see below).
    2) Active inflammation on MRI of the SIJs and/or spine as evaluated by a central SpA imaging expert and/or radiographic modified New York criteria fulfilled as judged by a central SpA imaging expert.
    3) Active disease defined as ASDAS ≥ 2.1 (ASDAS high disease activity).
    4) Total back pain as measured on a VAS scale ≥ 4 0 mm (0-100 mm) at baseline.
    5) Clinical indication for a biologic drug as assessed by the treating physician.
    6) Patients should have received at least 2 different NSAIDs at the highest recommended dose for at least 2 weeks each with an inadequate response or failure to respond, or less if therapy had to be reduced due to intolerance, toxicity or contraindications.
    7) Patients on NSAIDs at inclusion should stay on a stable dose from at least 2 weeks before the baseline MRI scans are performed and to the week 24 visit.
    8) Patients on sDMARDs (syntetic DMARDs) at inclusion should stay on a stable dose from at least 4 weeks before initiation of secukinumab to the week 24 visit.
    9) Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must provide written, signed and dated informed consent before any study assessment is performed.
    10) Male or female patients at least 18 years and less than 70 years of age.
    11) Sufficient contraception for women.
    12) Age ≥18 to <70 years.
    13) Capable of giving informed consent.
    14) Capable of complying with the examination programme of the protocol.
    E.4Principal exclusion criteria
    1) Contraindications for secukinumab (described in protocol).
    2) Contraindication for TNF inhibitor (described in protocol).
    3) Contraindication for MRI (described in protocol).
    4) Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor
    5) Previous exposure to TNF inhibitor or drug targeting TNF.
    6) Previous exposure to other types of bDMARDs than TNF inhibitor (e.g. anti-interlukin 1, anti-interleukin 6, anti-interleukin 12/23, anti-interleukin 23, anti-CD20, co-stimulation inhibitors, JAK-inhibitors etc).
    7) Patients taking high-potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
    8) Any change in the dose of oral corticosteroids in the last 4 weeks prior to the baseline visit or use of i.v. intramuscular or intra-articular corticosteroid during the last 8 weeks prior to the enrollment visit.
    9) Use of any investigational drug and/or devices within 4 weeks before randomization or a period of 5 half-lives of the investigational drug, whichever is longer.
    10) Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
    11) Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g. 20 weeks in EU).
    12) Known recent drug or alcohol abuse.
    13) Incapable of complying with the examination programme for physical or mental reasons.
    14) Failure to provide written consent
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is defined as the proportion of patients with an improvement in MRI inflammation from week 16 to 24. This is defined as measured a positive change in MRI inflammation score ≥2 in the SIJs and spine, as assessed with the sum of SPARCC MRI SIJ and spine inflammation indices
    E.5.1.1Timepoint(s) of evaluation of this end point
    After completion of the last patient visit in the study
    E.5.2Secondary end point(s)
    1) Proportion of patients at week 16 and 24 who are in ASDAS remission respectively not in ASDAS remission.
    2) Changes in ASDAS score from week 16 to 24 and from week 0 to 16, respectively.
    3) Proportion of patients improving from week 16 to 24 (as measured by a positive change in MRI inflammation in the spine as assessed with the Canada-Denmark MRI system for assessment of inflammation).
    4) Changes in MRI inflammation scores from week 0 to 16 and week 16 to 24, respectively (as measured by the SPARCC MRI SIJ and Spine Inflammation indices and the Canada-Denmark MRI system for assessment of inflammation).
    5) Changes in scores/anatomical location of MRI lesions in the spine (as measured by the Canada-Denmark MRI system for assessment of inflammation, fat metaplasia, erosion, and new bone formation).
    6) Changes in scores/anatomical location of MRI lesions in the SIJs (as measured by the SPARCC MRI SIJ Inflammation Index and SPARCC SIJ Structural Score (SSS)
    7) MRI inflammation (as measured by the SPARCC MRI SIJ and Spine Inflammation indices and the Canada-Denmark MRI system for assessment of inflammation assessed on cMRI i.e. on STIR sequences on conventional and novel scan planes and on DWI sequences evaluated visually and based on regions of interest (ROIs)).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After completion of the last patient visit in the study
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    Dose will be increased or maintained after predetermined intervals depending on remission
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned10
    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 years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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.1.1.1In 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state88
    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 Decision2017-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
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