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    Summary
    EudraCT Number:2005-002423-13
    Sponsor's Protocol Code Number:WA18695
    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:2005-07-18
    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 number2005-002423-13
    A.3Full title of the trial
    Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822
    A.4.1Sponsor's protocol code numberWA18695
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann La-Roche Ltd
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.2Product code RO4877533
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 codeR04877533
    D.3.9.3Other descriptive nameMRA
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Rheumatoid arthritis
    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 long-term safety of 8 mg/kg tocilizumab (MRA) with regard to adverse events and laboratory result abnormalities
    E.2.2Secondary objectives of the trial
    • To explore the possibility of reducing concomitant steroid treatment
    • To determine the long-term efficacy of 8 mg/kg tocilizumab (MRA) with regard to reduction in signs and symptoms
    • To better understand and predict tocilizumab (MRA) efficacy, response, safety, progression of RA and associated diseases with regard to its effect on biomarkers
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Completion of 24 weeks of treatment with tocilizumab (MRA) in WA17822, and scheduled to receive the first tocilizumab (MRA) infusion in WA18695 between 4 and 12 weeks after the last iv infusion in WA17822. Patients that are prevented from enrollment prior to 12 weeks after the last iv infusion in WA17822 due to administrative delays outside of the control of the investigator and upon discussion with Roche may be included if they meet all other inclusion criteria, but will undergo a separate analysis of the study results.
    2) Able and willing to give written informed consent and comply with the requirements of the study protocol.
    3) Have received methotrexate at a stable dose of between 10 and 25 mg/week (p.o. or parenteral) since the last administration of study drug in WA17822.
    4) Oral corticosteroids (≤10 mg/day prednisone or equivalent) and NSAIDS (up to the maximum recommended dose) are permitted if dose stable since the last administration of study drug in WA17822.
    5) Must be willing to receive oral folate (at least 5 mg/week).
    6) Females of child-bearing potential and males with female partners of childbearing
    potential may participate in this trial only if using a reliable means of contraception (e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD).
    7) If female and of child-bearing potential, the patient must have a negative urine
    pregnancy test at baseline.
    E.4Principal exclusion criteria
    1) Treatment with any investigational agent since the last administration of study
    drug in WA17822.
    2) Previous treatment with any cell depleting therapies, including investigational
    agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti- CD20)
    3) Treatment with iv gamma globulin, plasmapheresis or Prosorba™ column since
    the last administration of study drug in WA17822.
    4) Treatment with an anti-TNF or anti-IL1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA17822.
    5) Parenteral, intramuscular or intra-articular corticosteroids within 6 weeks prior to
    baseline in WA18695.
    6) Immunization with a live/attenuated vaccine since the last administration of study
    drug in WA17822.
    7) Any previous treatment with alkylating agents such as cyclophosphamide or
    chlorambucil, or with total lymphoid irradiation.
    8) History of severe allergic or anaphylactic reaction to human, humanized or murine monoclonal antibodies.
    9) Evidence of serious uncontrolled concomitant cardiovascular, nervous system,
    pulmonary (incl. obstructive pulmonary disease), renal, hepatic, endocrine (incl.
    uncontrolled diabetes mellitus), immunologic or gastrointestinal disease; 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 to perforations for whom a favourable benefit/risk assessment for study continuation cannot be documented (see section 7.5.).
    10) Known active or history of recurrent bacterial, viral, fungal, mycobacterial or
    other infections (including but not limited to tuberculosis and atypical mycobacterial disease, clinically significant abnormalities on chest X-ray as determined by the investigator, HIV, hepatitis B and C, and Herpes zoster, but excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with iv antibiotics within four weeks prior to baseline or oral antibiotics within two weeks prior to baseline.
    11) Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including solid tumors and hematologic malignancies, except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years.
    12) Patients whose AST or ALT ≥ 3 times ULN, bilirubin > 2 times ULN or > 2.5 mg/dL (43 umol/L), neutrophils < 1000/cubic mm (1 x 103 /uL or 1 GI/L), or who have an infection.
    13) Patients with history of inflammatory lower GI disease, such as diverticulitis, colitis, enteritis, as well as symptomatic diverticulosis (with or without history of bleeding) are excluded.

    Patients already randomized in the study will be re-evaluated for history of lower GI disease at the next scheduled study visit and their risk/benefit assessed to determine if they may continue in the study (details given in Section 7.5). If agreed to continue in the study, patients with history of lower GI disease will be required to sign an addendum to the informed consent indicating their willingness to remain in the study and undergo the additional tests required. Patients who have a negative outcome to the risk/benefit assessment or who are not willing to undergo the additional tests will be withdrawn.
    E.5 End points
    E.5.1Primary end point(s)
    The primary parameters of interest are safety and long-term efficacy.
    The following endpoints will be summarized descriptively:
    • The safety of tocilizumab (MRA) with regard to adverse events and laboratory result abnormalities.
    • Concomitant steroid treatment will be summarized by visit.
    • Number of patients who withdraw from treatment.
    • The proportion of patients achieving an ACR20, ACR50 and ACR70 response by visit.
    • The proportion of patients who maintain an ACR20, ACR50 or ACR70 response consecutively for 24, 48, 96 and 264 weeks.
    • The individual components of the ACR core set will be summarized by visit.
    • Change in Disease Activity Score (DAS28) from first dose of 8 mg/kg tocilizumab (MRA) to weeks 24, 48, 96 and 264.
    • Change in Disease Activity Score (DAS28) from WA18695 baseline to weeks 24, 48, 96 and 264.
    • The proportion of patients who are categorical DAS responders (EULAR response) at 24, 48, 96 and 264 weeks.
    • The proportion of patients who remain categorical DAS responders (EULAR response) consecutively for 24, 48, 96 and 264 weeks.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 trial will occur when the last participating patient completes the last scheduled visit, or when the sponsor decides to discontinue the development programme.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months9
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-07-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 255
    F.4.2.2In the whole clinical trial 630
    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)
    Study WA18695 will last 264 weeks irrespective of commercial availability of tocilizumab. If tocilizumab will not become commercially available the patient's physician will provide treatment with standard therapy once the trial has ended.
    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 Decision2005-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-02
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