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    Summary
    EudraCT Number:2019-001145-40
    Sponsor's Protocol Code Number:P17-03
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-11-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-001145-40
    A.3Full title of the trial
    French prospective open label phase II randomized non-comparative study of SC tocilizumab associated with IV pulse steroid versus IV pulse steroid alone for the treatment of acute anterior ischemic optic neuropathy associated with giant cell arteritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of tocilizumab for the treatment of acute anterior ischemic optic neuropathy of giant cell arteritis
    Efficacité du tocilizumab pour le traitement de la neuropathie optique ischémique antérieure aigue de la maladie de Horton
    A.3.2Name or abbreviated title of the trial where available
    TOCIAION
    A.4.1Sponsor's protocol code numberP17-03
    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 SponsorCentre Hospitalier National d’Ophtalmologie des Quinze-Vingts
    B.1.3.4CountryFrance
    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 supportROCHE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier National d’Ophtalmologie des Quinze-Vingts
    B.5.2Functional name of contact pointDr Emmanuel Heron
    B.5.3 Address:
    B.5.3.1Street Address28 rue de Charenton
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75012
    B.5.3.4CountryFrance
    B.5.4Telephone number+330140021604
    B.5.5Fax number+330140021608
    B.5.6E-maileheron@15-20.fr
    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 RoActemre
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameRoactemra
    D.3.2Product code L04AC07
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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, acute anterior ischemic optic neuropathy
    E.1.1.1Medical condition in easily understood language
    Giant cell arteritis, acute anterior ischemic optic neuropathy
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10043207
    E.1.2Term Temporal arteritis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10030924
    E.1.2Term Optic ischaemic neuropathy
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the efficacy of a one-month tocilizumab treatment as induction therapy in combination with high dose steroids in patients with anterior ischemic optic neuropathy (AION) due to giant cell arteritis, as judged at W8 after treatment start : Occurrence of a visual improvement defined as an increase of two lines or more of visual acuity on the ETDRS chart
    E.2.2Secondary objectives of the trial
    • To determine if induction therapy by 4 subcutaneous tocilizumab injections over one month (every 7 days) in association to conventional steroid regimen could stabilize ocular outcome in AION related to GCA.
    • To assess the efficacy of 1-month, tocilizumab treatment on the other manifestations of GCA (clinical remission, associated rhizomelic polyarthritis)
    • W4 and W13 Occurrence of a visual improvement defined as an increase of two lines or more of visual acuity on ETDRS chart
    • W4, W8 and W13 changes in Mean Deviation (MD) measured on an automatized Visual Field ( SITA Standard Humphrey 24-2)
    • Changes in angio-OCT between baseline and Week 4 : superficial and deep vascular plexus will be examined to look for the decrease of ischemia in peripapillary and macular areas.
    • To assess the recurrence rate at W13
    • To determine immunological biomarkers predictive of response to Tocilizumab (ancillary study)
    • To assess the safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of GCA : ACR criteria (annex 1)
    • Sudden permanent visual loss due to AION, of less than one week
    • Diagnosis of AION, characterized by sudden and painless loss of vision, accompanied by pallid swelling of the optic disc
    • Age of 50 years or older
    • Social insurance
    E.4Principal exclusion criteria
    • Other ocular involvements related to GCA (central retinal artery occlusion, posterior ischemic optic neuropathy, transient ocular manifestations, occipital stroke), if not associated with AION
    • Biological targeting therapy within 3 months preceding the study
    • Evidence of active infection
    • History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin or solid tumors treated with curative therapy and disease-free for at least 5 years
    • History of recurrent infections, diverticulitis or intestinal ulceration and ASAT/ALAT > 5 * upper limit of normal, according to the Summary of Product Characteristics of tocilizumab
    • Contraindication to steroids and/or aspirin administrated in the treatment
    • Breastfeeding women and women with childbearing potential without highly effective contraception.
    • Pregnant or nursing (lactating) women confirmed by a positive βHCG laboratory test at the inclusion
    • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during study treatment and for 3 months after the last administration of tocilizumab.
    • Cytopenia, as defined by platelet count < 100 × 109/L (100,000/mm3), hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L), absolute neutrophil count < 2.0 × 109/L (2000/mm3), absolute lymphocyte count < 0.5 × 109/L (500/mm3)
    • Insufficient liver function (Child Pugh C )
    • Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less
    • Patients with previously untreated tuberculosis, previously known TDM/radiographic evidence suggestive of active and/or sequellar tuberculosis
    • HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen if known before study inclusion
    • Contraindication to and precaution in use of tocilizumab according to the summary product description
    • Inability to provide informed consent
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the ocular improvement at W8. This improvement will be defined as the increase of at least two lines of visual acuity on the ETDRS chart.
    E.5.1.1Timepoint(s) of evaluation of this end point
    W8
    E.5.2Secondary end point(s)
    1- Stabilization of vision, as judged at W8 after treatment start, correspond to a lack of improvement (cf primary objective), and a lack of deterioration defined as follows:
    - If the patient can see the light initially, no light perception at W8 will represent a deterioration
    - If the patient is able to count finger at any distance, but the visual acuity is less than 20/400 on the ETRS chart, a “off chart” visual acuity at W8 will represent a deterioration
    - If initial visual acuity is equal or more than 20/400, a loss of 2 lines or more on the ETDRS at Week 8 will represent deterioration
    2- Occurrence of a visual improvement defined as an increase of two lines or more of visual acuity on ETDRS chart, a clinically significant difference, at W4 and W13
    3- Change in Mean Deviation (MD) measured on an automatized Visual Field (SITA Standard Humphrey 24-2) at weeks 4, 8, and 13.
    4- Changes in angio-OCT between baseline and W4 and W13: superficial and deep vascular plexus will be examined to look for the decrease of ischemia in peripapillary and macular areas.
    5- Proportion of patients with improvement of other manifestations of GCA with tocilizumab and prednisone at weeks 2, 4, 8, and 13.
    6- Proportion of patients with biological improvement (i.e. CRP and ESR) with tocilizumab and prednisone at weeks 2, 4, 8, and 13.
    7- Influence of 1-month tocilizumab treatment on recurrence of AION, at W13.
    8- Influence of 1-month tocilizumab treatment on recurrence of GCA, at W13.
    9- Time to first recurrence of GCA
    10- Safety as assessed by adverse events, and serious adverse events.
    11- Immunological biomarkers of response to Tocilizumab assessed at W2, W4, W8 and W13.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- at W8
    2- at W4 and W13
    3- at weeks 4, 8, and 13.
    4- between baseline and W4 and W13
    5- at weeks 2, 4, 8, and 13.
    6- at weeks 2, 4, 8, and 13.
    7- at W13.
    8- at W13.
    9-10 each week
    11- at W2, W4, W8 and W13.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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.8.3 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 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
    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 months15
    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: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 state58
    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 Decision2019-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-24
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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