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    Summary
    EudraCT Number:2015-002466-22
    Sponsor's Protocol Code Number:990758
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-12-23
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-002466-22
    A.3Full title of the trial
    A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open­label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuiL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Openlabel Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuiL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis
    A.4.1Sponsor's protocol code number990758
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/066/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen Inc
    B.1.3.4CountryUnited States
    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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen Inc.
    B.5.2Functional name of contact pointNick Yeager
    B.5.3 Address:
    B.5.3.1Street AddressOne Amgen Center Drive
    B.5.3.2Town/ cityThousand Oaks
    B.5.3.3Post codeCA 90049
    B.5.3.4CountryUnited States
    B.5.4Telephone number001805447-0659
    B.5.6E-mailnyeager@amgen.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 No
    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 nameanakinra
    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 INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.4EV Substance CodeSUB05500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Juvenile Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Juvenile Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study was to evaluate the safety of anakinra
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Boys or girls age 2 to 17 years (inclusive)
    • Minimum weight of 10 kg
    • Availability of an adult to assist with administration of SC injections of study drug and/or subjects capable of adequately performing self-injection technique as judged by the investigator
    • Available for assessments
    • Polyarticular, pauciarticular or systemic disease onset
    • Active polyarticular-course JRA with at least 5 swollen joints due to active arthritis (not bony overgrowth) and 3 joints with limitation of motion (LOM) at screening and the day 1 visit
    • Stable doses of background methotrexate (minimum 10 mg/m2/week, maximum 40 mg/week) for 6 consecutive weeks before the first dose of anakinra and throughout the trial (subjects not receiving background methotrexate or any other DMARD for 6 weeks before the first dose of anakinra could be enrolled but not initiate methotrexate treatment while participating in this study)
    • Subjects who continued methotrexate were required to take either 1 to 5 mgs/day folic acid at least 5 days/week or 2.5 to 15 mgs folinic acid the day after methotrexate administration
    • Subjects had at least a 4-week washout of any other biologic therapy (eg, etanercept and infliximab) before the first dose of anakinra
    • Stable doses of NSAIDS (including Cox-2 inhibitors e.g. celecoxib and rofecoxib) and systemic oral corticosteroids (≤ 10 mg/day or 0.2 mg/kg/day of prednisone; whichever was less) for 4 weeks before the first dose of anakinra and during the trial
    • Subjects who received leflunomide must have completed the prescribed course of cholestyramine washout
    • Provision of written informed consent for participation in the study by the subject or legally acceptable representative before any study-specific procedure was performed
    E.4Principal exclusion criteria
    • Presence of any uncontrolled, clinically significant systemic disease, hepatic, renal, neurological, endocrine, cardiac, gastrointestinal (except NSAID-induced GI problems), or hematologic disease within 24 weeks of first dose of anakinra
    • Presence of symptoms of systemic disease at screening (intermittent fever, rash, hepatosplenomegaly, pericarditis)
    • Known diagnosis of hepatitis or HIV
    • A malignancy other than basal cell or in situ carcinoma of the cervix within the previous 5 years
    • Presence of any other rheumatic disease or major chronic infectious, inflammatory, immunologic disease (inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, systemic lupus erythematosus)
    • Infection at screening or development of frequent, acute or chronic infection within 4 weeks
    • Joint replacement required during the study
    • ALT or AST > 2.0 or creatinine > 1.5 times the upper limit of normal range (confirmed by repeated measure)
    • White blood cell count < 2.0 x 109/L and/or neutrophil count < 1.5 x 109/L and/or
    platelet count < 150 x 109/L
    • Concurrent treatment with a DMARD other than methotrexate
    • Concurrent treatment of methotrexate < 10 mg/m2/week or > 40 mg/week
    • Received intra-articular or systemic corticosteroid injection within 4 weeks
    • Received live viral vaccines within 3 months of study
    • Current enrollment in any other interventional clinical study or concurrent treatment with an investigational agent within 4 weeks of study
    • Active substance abuse
    • Known allergy to E coli-derived products
    • Any disorder that compromised the ability to give informed consent for participation in the study, comply with protocol procedures, and/or be available for follow-up assessment
    • Lack of adequate contraceptive precautions
    • Pregnancy (eg, positive test for human chorionic gonadotropin), ongoing breastfeeding, or intention to become pregnant during the study
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events and laboratory assessment over time
    E.5.1.1Timepoint(s) of evaluation of this end point
    12+16 weeks
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    Open phase followed by double blind phase
    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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Australia
    Canada
    Costa Rica
    New Zealand
    United States
    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.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 90
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 43
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 43
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 90
    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)
    Normal treatment of that condition
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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