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    Summary
    EudraCT Number:2016-004990-42
    Sponsor's Protocol Code Number:PMR-SPARE
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-08-21
    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 ConcernedAustria - BASG
    A.2EudraCT number2016-004990-42
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled,
    Parallel Group Study to Evaluate the Efficacy of
    Tocilizumab as a Remission-Induction and
    Glucocorticoid-Sparing Regimen in Subjects with
    New-Onset Polymyalgia Rheumatica (PMR-SPARE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized study to evaluate the efficacy of Tocilizumab to induce Remission and to spare Glucocorticoids in subjects with new-onset Polymyalgia Rheumatica.
    A.3.2Name or abbreviated title of the trial where available
    PMR-SPARE
    A.4.1Sponsor's protocol code numberPMR-SPARE
    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 SponsorMedizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie
    B.1.3.4CountryAustria
    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 supportHoffmann - La Roche
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaniel Aletaha
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressWaehringer Guertel 18 - 20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.6E-maildaniel.aletaha@meduniwien.ac.at
    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 - Solution for injection in pre-filled syringe - TOCILIZUMAB 162 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 injection in pre-filled syringe
    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 INNtocilizumab
    D.3.9.1CAS number 375823-41-9
    D.3.9.2Current sponsor codeRo4877533
    D.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number162
    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 in pre-filled syringe
    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
    Polymyalgia rheumatica

    Polymyalgia rheumatica is an inflammatory rheumatic disease that occurs primarily in the elderly with a peak incidence around 70 years of age. It is clinically characterized by shoulder girdle and hip pain and stiffness which impair raising arms and rising from a chair.
    E.1.1.1Medical condition in easily understood language
    Polymyalgia rheumatica is an inflammatory rheumatic disease that occurs primarily in the elderly. It is clinically characterized by shoulder girdle and hip pain and stiffness.
    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 assess the efficacy of a tocilizumab-based regimen compared with placebo on top of rapidly tapered glucocorticoid treatment in a double-blind, controlled fashion, focussing on GC-free remission of disease.
    E.2.2Secondary objectives of the trial
    To assess the safety of a tocilizumab-based regimen compared with placebo on top of rapidly tapered glucocorticoid treatment in a double-blind, controlled fashion, focussing on glucocorticoid-free remission of disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of PMR as confirmed by the investigator at screening and at baseline, fulfilment (also in retrospect) of the provisional 2012 ACR-EULAR classification criteria

    Diagnosis of PMR established at, or up to 2 weeks before the screening visit

    GC naïve or on GC treatment for a maximum of 2 weeks at screening with an initial dose between 12.5 and 25mg/day prednisone

    Willing and able to receive oral prednisone 20mg/day at randomization and to follow a pre-specified tapering regimen

    Willing to receive treatment for prevention of GC-induced bone loss

    No evidence of active infection with Mycobacterium tuberculosis (screening performed according to national guidelines) and willing to take TB prophylaxis in case of evidence of latent TB

    Willing and being able to understand and follow the study procedures

    Male and female subjects agreeing to conduct efficient contraception (unless they have no childbearing potential)

    Written informed consent.

    Female and Male subjects from 18 years old and higher
    E.4Principal exclusion criteria
    Evidence of GCA (cranial or large vessel) as indicated by unequivocal clinical symptoms (except PMR), imaging and/or biopsy results. Routine screening of eligible PMR patients for GCA with imaging methods or temporal artery biopsy is not recommended

    GC treatment of PMR >2 weeks

    Conditions other than PMR requiring continuous or intermittent treatment with oral or parenteral GCs or parenteral administration of GCs, unless the last exposure to GCs was >1 months before screening

    Other inflammatory rheumatic diseases (e.g. rheumatoid arthritis)

    Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization

    Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening

    Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples include: CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20

    Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline

    Immunization with a live/attenuated vaccine within 4 weeks prior to baseline

    Previous treatment with Tocilizumab (an exception to this criterion may be granted for single dose exposure upon application to the sponsor on a case-by-case basis)

    Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation

    History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies

    Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn´s disease)

    Diagnosis of liver disease or elevated hepatic enzymes, as defined by ALT, AST, or both > 1.5 x the upper limit of age-determined normal (ULN) or total bilirubin > ULN

    Serum creatinine > 1.6 mg/dL (141 μmol/L) in female patients and > 1.9 mg/dL (168 μmol/L) in male patients. Patients with serum creatinine values exceeding limits may be eligible for the study, if their estimated glomerular filtration rates (GFR) are > 30

    Total Bilirubin > ULN

    Any history of recent serious bacterial, viral, fungal, or other opportunistic infections

    Have serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C

    Positive QuantiFERON TB test, history of Tuberculosis, or active Tuberculosis-infection, without at least 4 weeks of adequate therapy for Tuberculosis

    Active infection with EBV as defined by EBV viral load > 10,000 copies per mL of whole blood

    Any of the following hematologic abnormalities, confirmed by repeat tests:
    a. White blood count < 3,000/μL or > 14,000/μL;
    b. Lymphocyte count < 500/ μL;
    c. Platelet count < 100,000/μL;
    d. Hemoglobin < 8.0 g/dL; or
    e. Neutrophil count < 2,000 cells/μL

    Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening

    Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation

    Any medical or psychological condition that in the opinion of the Principal Investigator would interfere with safe completion of the trial

    History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer

    Pregnant women or nursing (breast feeding) mothers

    Patients with reproductive potential not willing to use an effective method of contraception

    History of alcohol, drug or chemical abuse within 1 year prior to screening

    Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation

    Patients with lack of peripheral venous access
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects in GC free remission at week 16



    E.5.1.1Timepoint(s) of evaluation of this end point
    week 16
    E.5.2Secondary end point(s)
    Cumulative prednisone doses at weeks 12, 16 and 24

    Number of flares per patient at weeks 12, 16 and 24

    Time to first and second flare

    Patient reported outcomes including SF-36, FACIT-Fatigue, HAQ, Patient Global Assessment of Disease Activity (PGA), Patient assessment of pain

    Investigator reported outcomes including Evaluator Global Assessment of disease activity (EGA), Duration and severity of Morning Stiffness, Elevation of upper limbs

    Occurrence of adverse events and serious adverse events, incidence of GC related adverse events, changes in vital signs, haematology and clinical chemistry parameters

    Proportion of subjects with increased ESR (>20mm/h) and CRP levels (> 5mg/L) at week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 12, 16 and 24

    Occurrence of adverse events and serious adverse events, incidence of GC- related adverse events, changes in vital signs, haematology and serum chemistry parameters will be peformed at every visit.
    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 No
    E.6.5Efficacy No
    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) 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 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 concerned3
    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 years
    E.8.9.1In the Member State concerned months18
    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: 26
    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 state36
    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)
    Expected normal treatment
    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 Decision2017-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-02
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