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    Summary
    EudraCT Number:2009-012520-84
    Sponsor's Protocol Code Number:0881A1-3338
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-31
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2009-012520-84
    A.3Full title of the trial
    A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
    A.3.2Name or abbreviated title of the trial where available
    CLIPPER
    A.4.1Sponsor's protocol code number0881A1-3338
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00962741
    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 SponsorWyeth Pharmaceuticals Inc, (a Pfizer Company) 500 Arcola Road, Collegeville, PA 19426 USA
    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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailclinicaltrials.govcallcentre@pfizer.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 holderWyeth Europa Ltd.
    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.3.4Pharmaceutical 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.3.10 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
    Extended oligoarticular juvenile idiopathic arthritis (JIA)
    Enthesitis-related arthritis (ERA)
    Psoriatic arthritis (PsA)
    E.1.1.1Medical condition in easily understood language
    Extended Oligoarticular Juvenile Idiopathic Arthritis (JIA), Enthesitis-Related Arthritis (ERA), and Psoriatic Arthritis (PsA)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10003246
    E.1.2Term 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
    Part 1: To assess the clinical benefit of etanercept in subjects with extended oligoarticular JIA, ERA, or PsA.
    Part 2: To assess the long-term safety of etnaercept in subjects with extended oligoarticular JIA, ERA, or PsA.
    E.2.2Secondary objectives of the trial
    Part 1: To assess the effect of etanercept on safety and physical functioning in subjects with extended oligoarticular JIA, ERA, or PsA.
    Part 2: To assess the effect of etanercept on clinical benefit and physical functioning in subjects with extended oligoarticular JIA, ERA, or PsA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subjects must have met ILAR criteria for diagnosis of 1 of the
    following JIA subtypes (see Attachment 1 for ILAR criteria) before the screening
    visit and must be within the specified age range at the time of the screening visit:

    - extended oligoarticular JIA between the ages of 2 and 17 years.
    - ERA between the ages of 12 and 17 years.
    - PsA between the ages of 12 and 17 years.

    2. At both the screening and baseline visits, the following criteria must be met for
    the relevant JIA subtype:
    - Extended oligoarticular JIA:
    - >= 2 active peripheral joints (swollen or, in the absence of swelling, limited
    range of motion accompanied by either pain or tenderness)
    - A history of intolerance or an unsatisfactory response to at least a 3 month
    course of at least 1 DMARD at an adequate dose.
    - PsA:
    - >= 2 active peripheral joints (swollen or, in the absence of swelling, limited
    range of motion accompanied by either pain or tenderness)
    - A history of intolerance or an unsatisfactory response to at least a 3 month
    course of at least 1 DMARD at an adequate dose.
    - ERA:
    - >= 2 active peripheral joints (swollen or, in the absence of swelling, limited
    range of motion accompanied by either pain or tenderness)
    - A history of intolerance or an unsatisfactory response to at least 1 of the following:
    - at least a 1 month course of at least 1 NSAID at an adequate dose
    OR
    - at least a 3 month course of at least 1 DMARD at an adequate dose.

    3. Subjects taking hydroxychloroquine, chloroquine, sulphasalazine, or MTX must
    have been receiving these for at least 3 months before the baseline visit. Only 1
    of these DMARDs is to be taken throughout the study and the dose must be held
    stable for at least 8 weeks before the baseline visit.

    4. All male and female subjects who, in the opinion of the investigator, are
    bologically capable of having children and are sexually active, must agree and
    commit to the use of a reliable method of birth control for the duration of the
    study and for 30 days after the last dose of investigational product.

    - Female subjects who, in the opinion of the investigator, are biologically capable
    of having children must have a negative urine pregnancy test at screening and
    baseline (day 1) before administration of investigational product.

    5. Either the subject or an available adult must be capable (according to the
    investigator’s judgment) of reconstituting and administering injections of SC
    etanercept.

    6. The parent or legally authorized representative/guardian of the subject must be
    able to read and complete the protocol-specified efficacy assessments.

    7. The subject and the parent or legally authorized representative/guardian of the
    subject must be willing and able to participate in all applicable aspects of the
    study
    E.4Principal exclusion criteria
    1. Subjects with systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or
    undifferentiated arthritis per ILAR criteria.
    2. Arthritis in an HLA-B27 positive male beginning after the 6th birthday (for PsA
    and extended oligoarticular JIA subtypes only as defined per ILAR criteria).
    3. The presence of immunoglobulin M (IgM) rheumatoid factor (RF) on at least 2
    occasions at least 3 months apart.
    4. Subjects with active uveitis within 6 months of the baseline visit.
    5. Subjects with other rheumatic diseases including but not limited to Lyme disease,
    systemic lupus erythematosus, systemic vasculitis, polymyositis, infectious or
    reactive arthritis, overlap syndrome (eg, Sharp’s syndrome), or Reiter’s syndrome.
    6. Subjects with pustular, or erythrodermic psoriasis.
    7. Prior treatment with any biologic drugs, including TNF inhibitors, abatacept,
    rituximab, and tocilizumab.
    8. Receipt within 6 months before the baseline visit:
    - Immunosuppressive drugs (excluding corticosteroids) (eg, cyclophosphamide,
    cyclosporine, azathioprine).
    - Leflunomide.
    9. Receipt within 3 months before the baseline visit:
    - Any investigational nonbiologic drugs or devices.
    10. Receipt within 2 month before the baseline visit:
    - Any live (attenuated) vaccines
    11. Receipt within 4 weeks before the baseline visit:
    - A combination of nonbiologic DMARDs (eg, hydroxychloroquine, chloroquine,
    sulphasalazine, MTX).
    - Nonbiologic DMARDs other than that which will be continued during the study
    (ie, hydroxychloroquine, chloroquine, sulphasalazine, or MTX), or those not
    listed under other exclusion criteria.
    - Ultraviolet A (UVA), ultraviolet B (UVB), or psoralen + UVA (PUVA) therapy for
    psoriatic lesions.
    12. Receipt within 2 weeks before the baseline visit:
    - More than 1 NSAID, or a change in the dose or type of the NSAID, or an NSAID
    dose greater than the maximum recommended dose.
    - More than 0.2 mg/kg/day or > 10 mg/day, whichever is less, of oral prednisone
    or equivalent, or a change in the dose of prednisone or its equivalent. Receipt
    of intra-articular or soft tissue corticosteroid injection or bolus intramuscular
    (IM) or corticosteroids.

    - Topical steroids, oral retinoids, topical vitamin A or D analog preparations or
    anthralin for psoriatic lesions (exception – topical therapies are permitted on
    the scalp, axillae, and groin at low to moderate strength; the dose and type
    must be held stable for at least 2 weeks before the baseline visit).

    13. Any major illness/condition or evidence of unstable clinical condition (eg,
    cardiovascular [including congestive heart failure], cerebrovascular, neurologic,
    metabolic, immunologic, infectious, hepatic, renal condition, uncontrolled
    diabetes mellitus or hypertension), or any serious disorder (eg, current or history
    of alcohol or drug abuse, current or history of psychiatric disease) that, in the
    investigator’s judgment, will substantially increase the risk associated with the
    subject’s participation in and completion of the study, or could preclude
    the evaluation of the subject’s response, or interfere with the subject’s ability to
    give informed consent.
    14. Pregnant or breastfeeding female subjects.
    15. Cancer or history of cancer.
    16. History of blood dyscrasias.
    17. History of Macrophage Activating Syndrome (MAS).
    18. History of demyelinating diseases (eg, multiple sclerosis or optic neuritis).
    19. Documented immunodeficiency disease, including subjects with known human
    immunodeficiency virus (HIV) at the time of the screening visit.
    20. Positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody
    (HBcAb), and/or hepatitis C virus (HCV).
    21. History of clinically significant drug-induced liver injury, liver cirrhosis or fibrosis at
    any time before the baseline visit.
    22. Active tuberculosis, history of tuberculosis or evidence of latent tuberculosis. A
    tuberculosis test, interpreted by the investigator according to local standards or
    country-specific guidelines, must be performed during the screening visit for
    subjects with no documentation of tuberculosis test results available within 12
    weeks before the baseline visit.
    23. Infection associated with hospitalization and/or parenteral antibiotics within 1
    month before the baseline visit.
    E.5 End points
    E.5.1Primary end point(s)
    The main endpoint for the combined population is the proportion of subjects meeting the ACR Pedi 30 criteria at week 12, defined as ≥ 30% improvement from baseline in at least 3 of 6 of the following variables, with worsening > 30% in no more than 1 of these variables:
    1. PGA of Disease Activity on a 21-circle VAS
    2. Parent/Patient Global Assessment on a 21-circle VAS
    3. CHAQ
    4. Number of active joints, defined as joints with swelling or, in the absence of swelling, joints with limitation of motion with pain and/or tenderness
    5. Number of joints with limited range of motion (see attachment 2)
    6. Laboratory measure of inflammation (CRP, see laboratory determination section of the protocol)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    ACR Pedi 30 at all other timepoints, ACR Pedi 50, 70, 90, and 100; PGA of Disease Activity; Patient/Parent Global Assessment; CHAQ; Number of Active Joints; Number of Joints with Limitation of Motion; CRP; Pain Assessment; Duration of Morning Stiffness; Disease Status; Tender Entheseal Assessment (for ERA subjects only); PGA of Psoriasis and BSA (for PsA subjects only)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96, or upon early withdrawal
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity as measured by formation of anti-etanercept antibodies
    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 Information not present in EudraCT
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    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
    Belgium
    Denmark
    Egypt
    France
    Germany
    Italy
    Latvia
    Lithuania
    Netherlands
    Norway
    Poland
    Russian Federation
    Spain
    Sweden
    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
    Last patient last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 2
    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: 2
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 73
    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 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
    <18 years old. Parent/ Guardian signature required.
    Refer to Child Assent form and ICF.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-30
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