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    The EU Clinical Trials Register currently displays   43854   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-001145-40
    Sponsor's Protocol Code Number:20021618
    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 number2012-001145-40
    A.3Full title of the trial
    Open-label Extension Treatment with TNFR:Fc for Participating Patients in TNFR:Fc Clinical Trials
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating long-term safety in adults with rheumatoid arthritis and in children and adolescents with childhood arthritis
    A.4.1Sponsor's protocol code number20021618
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00357903
    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.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 AddressOne Amgen Center Drive
    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
    Rheumatoid arthritis (RA) in adults and juvenile idiopathic arthritis (JIA) for subjects who did not respond to conventional DMARDS
    E.1.1.1Medical condition in easily understood language
    Arthritis in adults and children who did not respond well to older medicines
    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 of the cumulative dataset (the cumulative dataset includes subject data from study 20021618 as well as data from the the initial Enbrel study) was to evaluate the long-term safety of etanercept in subjects with DMARD-refractory RA or JIA. The primary objectives of the study-specific dataset (the study-specific dataset includes subject data from study 20021618 only) were the following:
    • Evaluate the long term safety of etanercept in various subject populations with RA or JIA
    • Evaluate improvement in physical function/disability and quality of life.
    E.2.2Secondary objectives of the trial
    The secondary objective of the cumulative dataset was to describe the demography, subject exposure to investigational product, study discontinuations over time, and long-term effectiveness of etanercept in subjects with DMARD-refractory RA or JIA.

    The secondary objective of the study-specific data set was to evaluate long term biological activity of etanercept in various subject populations with RA or JIA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Previous enrollment in etanercept protocols
    • No clinically significant adverse events thought to be due to etanercept during previous treatment.
    • Negative serum pregnancy test not more than 14 days before first dose of etanercept in women of childbearing protential (except for those who were surgically sterile, postmenopausal for at least 5 years, or prepubescent and not expected to reach sexual maturity for at least 1 year). Subjects who enrolled from a previous study coul have had the pregnancy test performed during the screening visit/Day 1.
    • No more than 1 NSAID at a dose greater than the maximum recommended dose from the package insert (this dose had to be stable for at least 2 weeks before administration of etanercept).
    • Maximum dose of 10 mg/day prednisolone or its equivalent (pediatric subjects from study 16.0016 could have received corticosteroids at a dose ≤ 0.2 mg/kg, with a maximum dose of 10 mg/day. Corticosteroid doses had to be stable for at least 2 weeks before administration of etanercept).
    • Heterosexually active men and women of childbearing potential had to agree to use medically accepted contraception (oral or subcutaneous contraceptives, intrauterine device, or condoms with spermicide) throughout the study, including during the screening/DMARD washout period, if applicable, and during the follow-up period.
    • SGOT and SGPT ≤ 2X ULN; serum bilirubin ≤ 2X ULN (pediatric subjects [Study 16.0016]); hemoglobin stable at ≥ 8.5 g/dl; platelet count ≥ 100,000/cmm; white blood cell count ≥ 3,500 cells/cmm; and serum creatinine ≤ 2 mg/dL.
    • Abel to self-inject or had a designee who could provide assistance.
    • Capable of understanding and giving written, voluntary informed consent or had a parent/guasdian who could do so on the subject’s behalf.

    E.4Principal exclusion criteria
    • Previous receipt of TNFR:Fc (p55), antibody ot TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein (DAB-IL-2)
    • Receipt of investigational drugs or biologics (other than etanercept) within 1 month before the first dose of etanercept in this study.
    • Receipt of DMARDS (eg: hydroxychloroquine, oral or injectable gold, azathioprine, cyclosporine, D-penicillamine, or sulfasalazine) within 2 weeks before the first dose of etanercept in this study.
    • Receipt of methotrexate (MTX) within 2 weeks before the first dose of etanercept in this study, except for subjects from study 16.0014 on combination MTX and etanercept.
    • Receipt of cyclosporine within 6 months before the first dose of etanercept in this study.
    • Pregnant or breast feeding
    • Significant concurrent diseases or change in medical condition since enrollment in previous etanercept studies including uncompensated congestive heart failure, myocardial infarction within 12 months of the first dose of etanercept in this study, unstable or stable angina pectoris, uncontrolled hypertension, devere pulmonary disease (requiring medical or oxygen therapy), history of cancer (other than resected cutaneous basal and squamous cell carcinoma, and in-situ cervical cancer) within 5 years of the first dose of etanercept in this study, diabetes mellitus requiring insulin therapy, known HIV seropositivity, known hepatitis B or C seropositivity, psoriasis (subjects on combination MTX and etanercept from study 16.0014), any conditionthe would cause this study to be detrimental to the subject as judged by the subject’s physician. Individual cases in which the subject’s physician was uncertain about enrolling the subject into the study were to be discussed with the medical monitor.
    • Current or past psychiatric disease that could have interfered with ability to comply with the study or informed consent,
    • History of alcohol or drug abuse that would have interfered with compliance to the study protocol.
    • Subjects on combination MTX and etanercept treatment from study 16.0014 who were unwilling to limit alcohol consumption to less than 2 drinks per week (1 drink equals 12 ounces of beer, 1 ounce of hard liquor, or 4 ounces of wine).
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    For adults, ACR 20 and for pediatric subjects, the Juvenile Arthritis Definition of Improvement (JA-DOI).
    Safety:
    For adults and pediatric subjects the primary safety endpoint was adverse events through year 1 and serious adverse event rates throughout the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monthly for first 2 months, then every 3 months for the rest of year 1, then every 6 months for rest of the study
    E.5.2Secondary end point(s)
    Efficacy: For Adults
    • ACR 50 and 70 responses
    • Duration of morning stiffness
    • Disease activity score (DAS-28)
    • C-reactive protein (CRP)
    • Simple disease activity index (SDAI)
    • Clinical disease activity index (CDAI)
    • Complete response defined as 0 swollen joints and 0 tender joints
    • Remission based on DAS-28 and CRP
    • Change from baseline in ACR components
    • Change from baseline in DAS-28, CRP, CDAI and SDAI.
    • Change from baseline in morning stiffness
    Efficacy: For Pediatric Subjects
    • Juvenile arthritis definition of improvement (JA-DOI) 30%, 50%, 70%, 90% and 100%
    • JA-DOI components, including physician global assessment (PGA), subject’s/parent’s global assessment (SGA), number of active joints, Childhood Health Assessment Questionnaire (CHAQ), CRP, loss of motion (LOM) joint count.
    • LOM plus tender/painful joint count, subject’s pain VAS, articular severity score, duration of morning stiffness and complete response (0 swollen joints and 0 tender joints)
    Safety endpoints for the cumulative dataset were:
    • Exposure to etanercept
    • Safety-related discontinuations
    • Serious adverse events, including serious infectious events and deaths
    • Other predefined events of interest (eg: malignancies, infections, cardiovascular events and demyelination events)
    Safety endpoints for the study-specific dataset
    • Exposure to etanercept
    • Vital signs and physical exams
    • All serious and non-serious adverse events
    • Hematology profile
    • Chemistry profile, including urinalysis
    • Premature discontinuations
    • Other predefined events of interest (eg: hospitalizations, deaths, serious infections, malignancies, and other connective tissue disease).

    E.5.2.1Timepoint(s) of evaluation of this end point
    Monthly for first 2 months, then every 3 months for the rest of year 1, then every 6 months for rest of the study
    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) 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 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years11
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days10
    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: 58
    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: 29
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 29
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 583
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 131
    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 783
    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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