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    Summary
    EudraCT Number:2011-002363-15
    Sponsor's Protocol Code Number:ML27901
    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:2011-07-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-002363-15
    A.3Full title of the trial
    Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis.
    A.3.2Name or abbreviated title of the trial where available
    ACT FAST
    A.4.1Sponsor's protocol code numberML27901
    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 a/s
    B.1.3.4CountryDenmark
    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 a/s
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoche a/s
    B.5.2Functional name of contact pointMedical Manager Birte Agular
    B.5.3 Address:
    B.5.3.1Street AddressIndustriholmen 59
    B.5.3.2Town/ cityHvidovre
    B.5.3.3Post code2650
    B.5.3.4CountryDenmark
    B.5.4Telephone number004536399839
    B.5.5Fax number004536399930
    B.5.6E-mailbirte.agular@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®
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 nameIL-6 receptor inhibitor, recombinant humanized monoclonal antibody
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeIL-6 receptor inhibitor recombinant humanized monoclonal antibody
    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
    Adult Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Adult Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Incidence of infusion reactions
    E.2.2Secondary objectives of the trial
    • To assess the incidence of discontinuations of TCZ due to AE and due to other causes.
    • To assess the incidence of increase in ALT, AST and lipids
    • To assess the number and % of patients achieving clinical remission (DAS28 < 2.6), LDA after 24 weeks.
    • To assess the number and % of patients achieving ACR20, ACR50, ACR70 and ACR90 after 24 weeks
    • To assess increase in HAQ after 24 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or non-pregnant, non-nursing female
    2. ≥ 18 years of age
    3. Receiving treatment on an outpatient basis
    4. RA of ≥ 6 months duration
    5. Moderate to severe active RA: (DAS28 ≥ 3.2)
    6. Patients on ≥ 1 non-biologic DMARDs and/or TNF-inhibitor at a stable dose for a period ≥ 8 weeks prior to treatment
    7. Patients with inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy
    8. If patients are receiving an oral corticosteroid, the dose must have been stable for at least 25 out of 28 days prior to treatment
    9. Able and willing to give written informed consent and comply with the requirements of the study protocol
    E.4Principal exclusion criteria
    1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
    2. Rheumatic autoimmune disease other than rheumatoid arthritis
    3. Functional class IV as defined by the ACR Classification of Functional Status in
    4. Prior history of or current inflammatory joint disease other than RA
    Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before screening
    5. Previous treatment with rituximab and abatacept

    6. Pregnant women or nursing (breastfeeding) mothers
    7. Females of child-bearing potential who are not using a reliable means of contraception, e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD
    8. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
    9. Preivious treatment with any cell-depleting therapy
    10. Preivious treatment with any tocilizumab
    11. History of or currently active primary or secondary immunodeficiency
    12. Known active current og history of recurrent infection (incliding TB)
    13. Body weight of > 150 kg
    E.5 End points
    E.5.1Primary end point(s)
    Infusion reactions as defined for the pivotale phase III trials. Infusion reactions are defined as any reaction that occurs during the infusion of tocilizumab or during the first 24 hours after the infusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At every study visit
    E.5.2Secondary end point(s)
    Safety
    o The number and percentage of patients, where the administration of tocilizumab was stopped due to adverse events and serious adverse events.
    o The number and percentage of patients, where the administration of tocilizumab was stopped for other reasons.
    o The number and percentage of patients with increased levels of ALT or AST > 1.5 ULN, > 3 ULN and > 5 ULN at any visits.
    o The number and percentage of patients with elevated levels of lipids, according to the guidelines for ATP III at any visits.

    Efficacy
    o The number and percentage of patients who achieved a significant clinical improvement in disease activity score 28, DAS28 (reductions of at least 1,2 units) per visit.
    o The number and percentage of patients who achieved low disease activity (DAS28 < 3,2) per visit.
    o The number and percentage of patients who achieved DAS28 remission (DAS28 < 2,6) per visit.
    o Average (or median) and SD (or quartiles) for DAS28 per visit.
    o The number and percentage of patients who achieved ACR20, ACR50, ACR70 and ACR90 at any visit.
    o Average (or median) and SD (or quartiles) for hsCRP per visit.
    o Average (or median) and SD (or quartiles) of HAQ per visit.
    o The number and percentage of patients who achieved a significant clinical HAQ-response, defined as an improvement of at least 0,22 units compared to baseline on HAQ-scale per visit.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety and efficacy evaluations will be done 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 No
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Normal infusion time of 1 hour
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    The end of the study will occur when the last patient, last visit occurs(LPLV). The LPLV is either the date of the last patient to complete the study, or the date at which the last data point from the last patient, which is required for statisitcal analysis, is received, whichever is the later date.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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.1.3Elderly (>=65 years) Yes
    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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 56
    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)
    Tocilizumab is an approved treatment for rheumatoid arthritis, and are used in most rheumatologic departments in Denmark.
    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 Decision2011-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-20
    P. End of Trial
    P.End of Trial StatusCompleted
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