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    Summary
    EudraCT Number:2012-001171-37
    Sponsor's Protocol Code Number:20021626
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-03-07
    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 number2012-001171-37
    A.3Full title of the trial
    A Phase IV Registry of Etanercept in Children With Juvenile Rheumatoid Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating safety and effectiveness in children with childhood arthritis
    A.4.1Sponsor's protocol code number20021626
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00078793
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/236/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320
    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.4.1Name of organisation providing supportPfizer, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportPfizer, Inc.
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportAmgen, Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen
    B.5.2Functional name of contact pointAmgen Medical Information
    B.5.3 Address:
    B.5.3.1Street AddressNot answered
    B.5.3.2Town/ cityThousand Oaks, California
    B.5.3.3Post code91320
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007726436
    B.5.5Fax number0018662926436
    B.5.6E-mailmedinfo@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 Yes
    D.2.1.1.1Trade name Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen, 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.3.1Product nameEnbrel (Etanercept)
    D.3.4Pharmaceutical form Powder and solvent for 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 INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen, 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.3.1Product nameEnbrel (Etanercept)
    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 INNETANERCEPT
    D.3.9.1CAS number 185243-69-0
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Juvenile idiopathic arthritis (JIA)
    E.1.1.1Medical condition in easily understood language
    Arthritis in children
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    The primary objective was to determine the long-term safety of etanercept administered with or without other disease-modifying anti-rheumatic drugs (DMARDS) in pediatric subjects with polyarticular course or systemic juvenile rheumatoid arthritis (JRA) compared to a control cohort of subjects with polyarticular course or systemic JRA receiving methotrexate (with or without other DMARDS)

    E.2.2Secondary objectives of the trial
    There were no secondary objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Boys or girsl agew 2 to 18 years (inclusive) with a diagnosis of systemic, polyarticular, or pauciarticular JRA defined by the American College of Rheumatology (ACR) criteria.
    • Duration of disease long enough for the subject to have been given an adequate trial of nonsteroidal anti-inflammatory drug (NSAID) and/or prednisolone.
    • Co-administration of other DMARDS that did not specifically inhibit TNF (eg: infliximab, thalidomide, D2E7 [adalimumab]).
    • Parent or legal guardian able and willing to give informed consent.
    • Disease course must have been polyarticular or systemic with active arthritis in greater than or equal to 3 joints at the time of starting methotrexate alone or methotrexate in combination with other DMARDS, etanercept alone or etanercept added to ongoing methotrexate or other DMARDS.
    • Pre-pubescent, or if post-pubertal at any time during the study and of childbearing potential must practice adequate contraception
    Etanercept Arm
    • Newly started etanercept or began etanercept within 6 months of enrollment into the study. Subjects who entered the study from selected Immunex protocols and may have received etanercept for up to 1 year had their time of exposure counted from the first dose of etanercept in the original Immunex study.
    Methotrexate Arm
    • Newly started methotrexate or began methotrexate within 6 months of enrollment into the study.

    E.4Principal exclusion criteria
    • Pregnant or nursing
    • Receipt of antibody to TNF (infliximab, adalimumab, or other anti-TNF), antibody to CD4 (anti CD4), or diphtheria interlukin-2 fusion protein (DAB-IL-2).
    • Participation in a study of an investigational drug or biologic other than etanercept that required informed consent ≤ 6 months.
    • Receipt of any of the following DMARDS: TNF inhibitors other than etanercept such as infliximab, thalidomide, adalimumab, cyclophosphamide, experimental agents; or other biologic agents
    • Any serious concurrent medical condition, either acute or chronic, which would compromise the subject’s ability to cooperate with the protocol requirements.
    • History of alcohol or drug abuse
    • Prior malignancies unless the subject had been disease-free for at least 5 years.
    • Serious concurrent medical conditions, either acute or chronic (including infections) that prevent the subject from receiving a TNF inhibitor.
    E.5 End points
    E.5.1Primary end point(s)
    Endpoints were not designated as primary or secondary. Study endpoints were:
    • Adverse event rates(including infection)and severity compared between treatment cohorts
    • Growth data (height, weight, age, and height percentile) and Tanner scores (at selected sites, approximately 30% of subjects) compared between treatment cohorts and to national norms
    • Occurrence of any new autoimmune disease
    • Cancer rates for each treatment cohort
    • Child Behavior Checklist sub-scales and total scores compared to baseline and between treatment arms
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints were at months 3, 6, 9, 12, 18, 24, 30, 36 or end of treatment except for Tanner Stage which was at months 6, 12, 18, 24, 30, 36 or end of treatment
    E.5.2Secondary end point(s)
    (see above)
    E.5.2.1Timepoint(s) of evaluation of this end point
    (see above)
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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
    Canada
    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 years7
    E.8.9.2In all countries concerned by the trial months10
    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 Yes
    F.1.1Number of subjects for this age range: 583
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 3
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 352
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 228
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 11
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Less than 18 years old. Parent/Guardian signature required
    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 594
    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)
    Please refer to protocol
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Pediatric Rheumatology Collaborative Study Group
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Pediatric Rheumatology Collaborative Study Group
    G.4.3.4Network Country Canada
    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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