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    Summary
    EudraCT Number:2014-004673-16
    Sponsor's Protocol Code Number:MA29585
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-004673-16
    A.3Full title of the trial
    Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.
    A.4.1Sponsor's protocol code numberMA29585
    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 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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@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
    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 RO487-7533/F10-04
    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 number180
    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.IMP: 2
    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 Prednisone Tablets USP, 5 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoxane Laboratories, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 RO001-9265/F04
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisone
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 Yes
    D.3.11.13.1Other medicinal product typePrednisone is a synthetic analog of glucocorticoids.
    D.IMP: 3
    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 Prednisone Tablets USP, 1 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoxane Laboratories Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 RO 001-9265/F02-01
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisone
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 Yes
    D.3.11.13.1Other medicinal product typePrednisone is an abalog of glucocorticoids.
    D.IMP: 4
    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 L04AC07
    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.3.9.4EV 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 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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    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 20.0
    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
    To compare the impact on disease activity of continued vs. tapered prednisone in RA patients with stable low disease activity (LDA [Disease Activity Score in 28 joints (DAS28) erythrocyte sedimentation rate (ESR) score <= 3.2]) or remission (DAS28 ESR score <= 2.6).
    E.2.2Secondary objectives of the trial
    -To compare the proportion of patients who continue vs. taper prednisone with LDA at Week 24, who haven't suffered a disease flare and showed no confirmed adrenal insufficiency requiring replacement therapy
    -To compare between patients who continue vs. taper prednisone:(1)changes in CDAI and SDAI (2)the proportion of patients with >=1 RA flare; time to first RA flare; number of RA flares; >=1
    administration of RA flare rescue medication; time to first administration, and number of administrations of RA flare rescue medication(3)cumulative prednisone exposure(4)the proportion of
    patients who maintain LDA and who maintain the baseline disease activity level(5)proportion of patients who permanently discontinue study treatment due to insufficient RA flare control,(6)changes in the ACR core set, (7)identify predictors of successful prednisone dosetapering (8) changes in patient-reported outcomes
    -To evaluate the safety and tolerability of TCZ and proposed prednisonetapering scheme
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - RA of >= 6 months duration diagnosed according to American College of Rheumatology (ACR)/European League against Rheumatology (EULAR) criteria
    Track TCZ-experienced patients:
    - Have received tocilizumab (TCZ) either subcutaneous (SC, 162
    milligrams [mg] once a week [QW]) or intravenous (IV, 8 mg/kilogram
    [kg] every 4 weeks [Q4W]) not exceeding 800 mg/dose for the
    treatment of RA for at least 24 weeks prior to randomization
    - Have received 5 15 mg/day of prednisone (or glucocorticoids (GCs)
    equivalent) for the treatment of RA for at least 20 weeks prior to
    screening
    - Currently receiving 5 mg/day of oral prednisone (or GC equivalent)
    at the screening visit
    - Have DAS28 ESR score <=3.2 assessed 4 to 6 weeks prior to
    randomization
    Track TCZ-naïve patients:
    - Have active RA (defined as DAS28 ESR score >3.2)
    - Are considered by the investigator as inadequate responders to
    conventional synthetic disease-modifying antirheumatic drug
    (csDMARDs) or biologic disease-modifying antirheumatic drug
    (bDMARDs). Are TCZ treatment naive or last TCZ was >12 months prior
    to screening and TCZ was not discontinued due to lack of efficacy, side
    effects, or any other safety reasons
    - Are receiving 5-15 mg/day prednisone (or GC equivalent) for the
    treatment of RA
    E.4Principal exclusion criteria
    - Major surgery (including joint surgery) within 8 weeks prior to
    screening, or planned major surgery during the study and up to 6
    months after randomization
    - Pregnant women or nursing (breastfeeding) mothers
    - In females of childbearing potential, a positive serum pregnancy test
    at screening
    - Females of childbearing potential unwilling or unable to use reliable
    means of contraception during study treatment and for a minimum of 3
    months after the last dose of TCZ
    - Body weight of >=150 kg
    - Lack of peripheral venous access
    - RA of functional class IV, as defined by the ACR Classification of
    Functional Status in Rheumatoid Arthritis
    - Rheumatic autoimmune disease other than RA, including systemic
    lupus erythematosus, mixed connective tissue disease, scleroderma,
    polymyositis, or significant systemic involvement secondary to RA (e.g.,
    vasculitis, pulmonary fibrosis, or Felty syndrome). Secondary Sjögren
    syndrome with RA may be allowed per the discretion of the investigator
    - Diagnosed with juvenile idiopathic arthritis or juvenile RA and/or RA
    before the age of 16 years
    - Prior or current inflammatory joint disease other than RA (e.g., gout,
    Lyme disease, sero-negative spondyloarthropathy, including reactive
    arthritis, psoriatic arthritis, arthropathy of inflammatory bowel disease),
    or prior or current joint infections
    - Previous history of primary or secondary adrenal insufficiency
    - Treatment with any investigational agent (tocilizumab excepted)
    within 4 weeks (or 5 half-lives of the investigational drug, whichever is
    longer) of screening. Treatment with csDMARDs, other DMARDS, and/or
    biologics for RA which is permanently discontinued within 5 half-lives
    prior to randomization
    - Previous treatment with any cell-depleting therapies, including
    investigational agents or approved therapies
    - Treatment with IV gamma globulin, plasmapheresis or Prosorba
    column within 6 months of screening
    - Intraarticular (IA) or parenteral GCs for the treatment of RA within 6
    weeks prior to randomisation (within 12 weeks prior ro randomization
    for intra-articular triamcinolone)
    - Previous treatment with GCs for conditions other than RA, at any dose
    and in any formulation used continuously for > 1 week, during the last 1
    year prior to screening. Current treatment with topical GC exceeding
    20% of body surface area
    - Immunization with a live/attenuated vaccine within 30 days prior to
    screening
    - Any previous treatment with alkylating agents such as chlorambucil or
    with total lymphoid irradiation
    - Inadequate haematological, renal and liver functions
    - Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus
    antibody (HCV Ab)
    - History of severe allergic or anaphylactic reactions to human,
    humanized, or murine monoclonal antibodies
    - Evidence of current serious uncontrolled cardiovascular (including
    uncontrolled hyperlipidaemia), nervous system, pulmonary (including
    obstructive pulmonary disease), renal, hepatic, endocrine (including
    uncontrolled diabetes mellitus) or gastrointestinal (GI) disease
    - Current liver disease as determined by the investigator
    - History of diverticulitis, peptic ulcer disease, 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
    - Known active current or history of recurrent bacterial, viral, fungal,
    mycobacterial, or other opportunistic infections (including, but not
    limited to, tuberculosis [TB] and atypical mycobacterial disease,
    hepatitis B and C, Epstein-Barr virus, cytomegalovirus and herpes zoster,
    but excluding fungal infections of nail beds)
    - Neuropathies or other conditions that might interfere with pain
    evaluation (e.g. fibromyalgia) and/or are typically treated with systemic
    GCs unless related to primary disease under investigation
    - 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
    - Active TB requiring treatment within the previous 3 years (patients
    previously treated for TB with no recurrence within 3 years are
    permitted). All TCZ-naïve patients must be screened for latent TB and if
    positive, should be treated following local practice guidelines prior to
    initiating TCZ
    - History of or currently active, primary or secondary immunodeficiency
    - Evidence of active malignant disease, malignancies diagnosed within
    the previous 10 years (including haematological malignancies and solid
    tumours, except basal and squamous cell carcinoma of the skin or
    carcinoma in situ of the cervix uteri that was excised and cured), or
    breast cancer diagnosed within the previous 20 years
    - History of alcohol, drug or chemical abuse within 1 year prior to
    screening
    - Pre-existing central nervous system (CNS) demyelination or seizure disorders
    E.5 End points
    E.5.1Primary end point(s)
    Change in DAS28 ESR between randomization and Week 24 post-randomization
    E.5.1.1Timepoint(s) of evaluation of this end point
    Randomization and Week 24
    E.5.2Secondary end point(s)
    1 The proportion of patients with LDA (DAS28 ESR score <= 3.2) at Week 24 post-randomization, who have not suffered a disease flare and who showed no confirmed adrenal insufficiency that required
    replacement therapy
    2 Change in clinical disease activity index (CDAI)/ simplified disease activity index (SDAI) between randomization and Week 24 postrandomization
    3 The proportion or patients with >=1 RA flare, the time to first RA flare and the number of RA flares
    4 The proportion of patients with >=1 dministration of RA flare rescue medication, the time to first administration, and the number of administrations of RA flare rescue medication
    5 Cumulative prednisone exposure (dose) between randomization and Week 24 post-randomization
    6 The proportion of patients who maintain LDA (DAS28 ESR score <=3.2) and the proportion of patients who maintain the baseline disease
    activity level at Week 24 post-randomization
    7 The proportion of patients who permanently discontinue study treatment due to insufficient RA flare control
    8 Changes in the ACR core set from randomization to postrandomization Week 24, including: swollen and tender joint counts; patient's assessment of pain and global status; physician's assessment
    of global status; Health assessment questionnaire–Disability index (HAQ-DI); and acute phase reactants (high sensitivity C-reactive protein
    [hsCRP] and ESR)
    9 Incidence of adverse events (AEs) including non-serious and serious AEs, and AEs of special interest
    10 Changes in vital signs, physical findings, and clinical laboratory results during and following TCZ administration
    11 Assessment of immunogenicity (anti-TCZ antibodies)
    12 Proportion of patients with confirmed adrenal insufficiency that required replacement therapy
    13 Rheumatoid arthritis impact of disease (RAID) score
    14 Work productivity and activity impairment questionnaire: Rheumatoid Arthritis (WPAI: RA)
    15 Health assessment questionnaire–Disability index (HAQ-DI) score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    2: From Randomization up to Week 24
    3-4: Up to Week 24
    5: From Randomization up to Week 24
    6: Week 24
    7: Up to Week 24
    8: From Randomization up to Week 24
    9-10: Up to Week 28
    11: Up to Week 24 (performed on event driven basis)
    12: Up to Week 24
    13-14: Enrolment (Track TCZ-naïve patients only), randomization and Week 24
    15: Randomization and Week 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Egypt
    France
    Germany
    Italy
    Lebanon
    Russian Federation
    Serbia
    Switzerland
    Turkey
    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
    The end of the trial is defined as the date of the last visit of the last participating patient in this study. This is expected to occur 28 weeks after the last patient has been randomized into the study.
    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 months20
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months20
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 226
    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)
    Management of patients completing the 24-week Tapering Phase will be according to local clinical practice at the discretion of the investigator (for both TCZ and prednisone). However, it is recommended that patients completing the 24-week Tapering Phase continue treatment with TCZ SC (or revert to TCZ IV in case the TCZ SC is not commercially available in their country) in addition to open-label prednisone to maintain disease control status.
    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 Decision2015-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-20
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