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    Summary
    EudraCT Number:2016-002716-41
    Sponsor's Protocol Code Number:ML39425
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-04
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-002716-41
    A.3Full title of the trial
    AN EXTENSION STUDY TO EVALUATE LONG TERM SAFETY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH GIANT CELL ARTERITIS WHO HAVE COMPLETED WA28119 CORE STUDY IN FRANCE, AND SUBSEQUENTLY HAVING FLARE OR PERSISTING DISEASE ACTIVITY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A STUDY TO EVALUATE LONG TERM SAFETY OF TOCILIZUMAB IN PATIENTS WITH GIANT CELL ARTERITIS WHO HAVE COMPLETED WA28119 CORE STUDY IN FRANCE
    A.4.1Sponsor's protocol code numberML39425
    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 SponsorROCHE SAS
    B.1.3.4CountryFrance
    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 supportROCHE SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationROCHE SAS
    B.5.2Functional name of contact pointOpérations Cliniques/ Direction Med
    B.5.3 Address:
    B.5.3.1Street Address30 cours de l'Ile Seguin
    B.5.3.2Town/ cityBoulogne-Billancourt cedex
    B.5.3.3Post code92650
    B.5.3.4CountryFrance
    B.5.6E-mailessaiscliniques@roche.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 Yes
    D.2.1.1.1Trade name RoActemra 162 mg solution for injection in pre-filled syringe
    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
    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.3.9.3Other 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Giant cell arteritis (GCA)
    E.1.1.1Medical condition in easily understood language
    An inflammatory disease of the blood vessels that typically occurs in individuals over 50 years of age. It can cause fever, headache, jaw or mouth pain and can lead to irreversible vision loss
    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 19.1
    E.1.2Level LLT
    E.1.2Classification code 10018250
    E.1.2Term Giant cell arteritis
    E.1.2System Organ Class 100000004866
    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 safety of SC TCZ in patients who have completed the 156-week WA28119 two-part study in France and require SC TCZ according Investigator’s Judgment.
    E.2.2Secondary objectives of the trial
    •To describe GCA disease activity based on the presence or absence of signs and symptoms.
    •To describe acute phase reactants erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) values from inclusion.
    •To describe the concomitant treatments with SC TCZ for GCA.
    •To describe the administration of SC TCZ.
    •To describe the duration between the date of last SC TCZ administration in study WA28119 and the date of first SC TCZ administration in the extension study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Able and willing to provide written informed consent and to comply with the requirements of the study protocol.
    2.Patient who completed the 156-week WA28119 core study in France.
    3.Patient who experienced at any time during WA28119 core study a clinical improvement based on the investigator’s judgment, and may continue to benefit from SC TCZ in this study.
    4.Patient whom the investigator wants to treat with SC TCZ for one of the following reasons:
    •Persistent active GCA at the time of completion of the 156-week WA28119 core study.
    •New flare occurring within 3 years after completion of the 156-week WA28119 core study
    E.4Principal exclusion criteria
    1.Patients who have prematurely withdrawn from the WA28119 core study for any reason
    2.Major surgery within 8 weeks prior to screening or planned major surgery within the next 12 months
    3.Major ischemic event, unrelated to GCA, within 12 weeks of inclusion
    4.Transplanted organs (except corneal transplant performed more than 3 months prior to inclusion)
    5.History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies or to prednisone
    6.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), psychiatric, osteoporosis/osteomalacia, glaucoma, corneal ulcers/injuries, or Gastrointestinal (GI) disease
    7.Current liver disease, as determined by the investigator (ie. Positive hepatitis B surface antigen or hepatitis C antibody)
    8.History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower GI conditions that might predispose a patient to perforations
    9.Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of the nail beds)
    10.Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of inclusion or oral antibiotics within 2 weeks of inclusion.
    11.Active TB requiring treatment within the previous 3 years.
    Patients treated for TB with no recurrence within 3 years and patients treated for latent TB within 3 years are eligible.
    12.Primary or secondary immunodeficiency (history of or currently active)
    13.Evidence of malignant disease or malignancies diagnosed since last WA28119 visit (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that have been excised and cured)
    14.Females of childbearing potential and females who are breastfeeding
    15.Males of reproductive potential who are not willing to use an effective method of contraception, such as condom, sterilization, or true abstinence throughout study and for a minimum of 6 months after study drug therapy.
    16.History of alcohol, drug, or chemical abuse within 1 year prior to inclusion
    17.Body weight > 150 kg
    Exclusion Related to Previous or Concomitant Therapy
    18.Treatment with any investigational agent within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) of inclusion (except TCZ)
    19.Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to Campath (alemtuzumab), anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20
    20.Treatment with IV gamma globulin or plasmapheresis within 6 months of inclusion
    21.Previous treatment with alkylating agents, such as chlorambucil, or with total lymphoid irradiation
    22.Immunization with a live/attenuated vaccine within ≤ 4 weeks prior to inclusion
    23.Treatment with hydroxychloroquine, cyclosporine A, azathioprine, or MMF within 4 weeks of inclusion
    24.Treatment with etanercept within 2 weeks; infliximab, certolizumab, golimumab, abatacept, or adalimumab within 8 weeks; or anakinra within 1 week of inclusion
    25.Previous treatment with tofacitinib
    26.Treatment with cyclophosphamide within 6 months of inclusion
    27.Patients requiring systemic CS for other conditions other than GCA, which, in the opinion of the investigator, would interfere with the assessments of the protocol.
    28.Receipt of > 100 mg daily intravenous methylprednisolone within 6 weeks of inclusion
    E.5 End points
    E.5.1Primary end point(s)
    Incidence, nature, and severity of adverse events

    E.5.1.1Timepoint(s) of evaluation of this end point
    Follow and assess during all the course of the study.
    E.5.2Secondary end point(s)
    1 / All patients ‘characteristics at inclusion of the extension study will be described
    2/Investigator’s assessment for disease activity will be described
    Patient’s VAS scale for GCA activity will be described
    3/ Change from inclusion of the extension study in ESR, CRP value will be described
    4 / Concomitant treatments with SC TCZ for GCA will be described by number of patients with TCZ monotherapy, TCZ combined with corticosteroid or TCZ combined with others
    5/ SC TCZ administration will be described with number of injection, dose administered, duration of treatment and period of interruption
    6/ Duration between the date of last SC TCZ administration in study WA28119 and the date of first SC TCZ administration in the extension study

    E.5.2.1Timepoint(s) of evaluation of this end point
    1 / V1
    2 / Wk48, Wk96, Wk156 or early withdrawal
    3/ Wk48, Wk96, Wk156 or early withdrawal
    4/ Follow and assess during all the course of the study.
    Secondary end point:
    5/ Follow and assess during all the course of the study.
    6/ V1
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned6
    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
    LPLV (160 weeks from inclusion in the extension study (including one follow-up call 4 weeks after last study drug administration) or when the SC formulation of TCZ becomes commercially available for GCA, whichever comes first)enter information in English and add any other language that is applicable
    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 months
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    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 state10
    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 Decision2017-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-21
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