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    Summary
    EudraCT Number:2010-020423-51
    Sponsor's Protocol Code Number:ETA0881X1-4718
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-27
    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 - PEI
    A.2EudraCT number2010-020423-51
    A.3Full title of the trial
    Remission Induction by Etanercept in Enthesitis related Arthritis JIA-Patients (juvenile undifferentiated Spondylarthropathy)
    Remissionsstudie mit Etanercept bei Kindern mit Enthesitis-assoziierter Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Remission Induction by Etanercept in Enthesitis related Arthritis JIA-Patients (juvenile undifferentiated Spondylarthropathy)
    Remissionsstudie mit Etanercept bei Kindern mit Enthesitis-assoziierter Arthritis –REMINDER Studie
    A.3.2Name or abbreviated title of the trial where available
    REMINDER-Study
    REMINDER-Studie
    A.4.1Sponsor's protocol code numberETA0881X1-4718
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAsklepios Klinik Sankt Augustin
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAsklepios Klinik Sankt Augustin
    B.5.2Functional name of contact pointAsklepios Klinik Sankt Augustin
    B.5.3 Address:
    B.5.3.1Street AddressArnold Janssen Str. 29
    B.5.3.2Town/ citySankt Augustin
    B.5.3.3Post code53757
    B.5.3.4CountryGermany
    B.5.4Telephone number+492241249200
    B.5.5Fax number+492241249203
    B.5.6E-mailg.horneff@asklepios.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 holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Role
    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 holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) 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 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
    Active enthesitis-related arthrtitis as a category of juvenile idiopathic arthritis (ERA-JIA) as determined by International League of Associations for Rheumatology (ILAR) criteria.
    E.1.1.1Medical condition in easily understood language
    Active enthesitis-related arthrtitis is a category of juvenile idiopathic arthritis (ERA-JIA)
    Die Enthesitis-assoziierte Arthritis (ERA) ist ein Subtyp der juvenilen idiopathischen 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10059176
    E.1.2Term Juvenile idiopathic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study is intended to generate first evidence that treatment with etanercept is safe and effective in patients diagnosed with ERA-JIA who are able to aquire stable remission (inactive disease).
    E.2.2Secondary objectives of the trial
    To evaluate the stability of remission off medication in patients treated with etanercept.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Parents / legal guardian and patient are willing to participate in the study and signed voluntarily the Informed Consent form.

    Parents / legal guardian are willing to actively supervise storage and administration of study drug and to ensure that the time of each dose is accurately recorded in the subject's diary.

    Patient and parents / legal guardian agree to comply with study requirements and are able to be at the clinic for all required study visits.

    Patient is at least 6 years old and has not reached his 18th birthday.

    Patient is currently not treated with a disease-modifying antirheumatic drug (DMARD) or if the patient is treated with sulfasalazine and treatment is planned to be continued throughout the study period, stable dose of sulfasalazin has been given for at least 4 weeks. If patient has been treated with other DMARD (Methotrexate, Leflunomide, Azathiopine, Hydroxychloroquine, Chloroquine …) treatment has be discontinued at least 28 days before baseline. Stable dosage of NSAIDs or at least 4 weeks before baseline, stable dosage of corticosteroids (≤ 0.2 mg of prednisone per kilogram per day, with a maximum of 10 mg per day) for at least 4 weeks before baseline, or both are permitted.

    IN FEMALE PATIENT IN WHOM MENARCHE HAS OCCURRED
    • Negative serum pregnancy test prior to administration of study medication.
    • Willingness to use an adequate method of contraception
    Adequate contraception can include abstinence if the investigator deems appropriate.

    Diagnosis of active ERA-JIA as determined by International League of Associations for Rheumatology (ILAR) criteria. The activity of the disease is judged with
    (I) a minimum of 3 active joints with either swelling not due to deformity or if no
    swelling is present with limiting of motion and pain or pain on movement,
    (II) a least a score of 3 of 10 for global assessment of the severity of disease by the physician
    (III) a least a score of 3 of 10 for global assessment of overall well-being by the
    patient or parent

    Patient have to meet all criteria for eligibility for treatment with etanercept according to SPC and local guidelines, with expection of the requirement of a minimum of five affected joints.

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

    Patient must be evaluated for active or latent TB infection according to the instructions of the protocol. If applicable: Guidelines regarding the treatment of latent TB must be followed prior to the administration of study medication.
    E.4Principal exclusion criteria
    Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 30 days prior to study screening

    Any preceding diagnosis of malignancy.
    Pregnant or breast feeding female.
    Female not willing to use appropriate contraception or sexual abstinence.

    Active gastrointestinal disease (e.g., inflammatory bowel disease)

    Significant blood clotting defect

    Preceding diagnosis of tuberculosis or any opportunistic infection including herpes zoster at any time.

    Patient has a history of any chronic disease other than JIA, especially chronic renal disease, liver disease, hematological, gastrointestinal, pulmonary, cardiological or neurological disease, which in the opinion of the investigator may influence the efficacy or safety of the study medication or which in the opinion of the investigator leads to an unacceptable risk for the patient if he participates in the study.

    Patient had a significant illness during a period of 4 weeks prior to the first administration of study medication other than JIA-related.

    Patient is abusing alcohol or drugs.

    AST (SGOT), ALT (SGPT), or BUN levels more than two times the upper level of normal, creatinine levels more than 1.5 mg/dl, or any other laboratory abnormality considered to be clinically significant within 28 days prior to baseline

    Received any investigational medication within 30 days prior to the first dose of study medication or scheduled to receive an investigational drug (other than the study medications) during the course of the study

    Patient plans to change dosing of oral corticosteroids within the study period.

    Patient has received i.v., i.m., i.a. or soft tissue injections of corticosteroids within 4 weeks before first administration of study medication.

    Patient has previously been admitted to this study.

    Patient has been treated with any other investigational agent within 30 days or 5 half-lifes of the agent, whichever is longer, prior to the screening evaluation.

    HIV infected
    Known past or current hepatitis infection

    Patient has a history of an expanding CNS neoplasm, active CNS infection, demyelinating disease, degenerative neurological disease or any progressive CNS disease.

    Patient has a poorly controlled diabetes.

    Received a live virus vaccine within 1 month prior to baseline

    Any concurrent medical condition which would, in the investigator's opinion, compromise the patient's ability to tolerate the study drug or would make the patient unable to comply with the protocol.

    Patient has a history of or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.

    Patient has a recent history of alcohol or drug abuse within the past 6 months that would interfere with ability to comply with protocol requirements.

    Any other inability to comply with the study requirements.

    Any contraindication listed in the German 'Fachinformation' of the drug Enbrel®.
    E.5 End points
    E.5.1Primary end point(s)
    inactive disease of ERA-JIA defined as

    • No active synovitis
    • No fever, rash, serositis, splenomegaly, or generalized
    lymphadenopathy attributable to JIA
    • No active uveitis
    • Normal CRP
    • Physician’s global assessment of disease activity indicates no
    active disease
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    withdrawal design; open label treatment phase,12 weeks before controlled 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 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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 visit after 70 days after adminitration for adverse event collection
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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.1.1.6Adolescents (12-17 years) Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    The patient will be followed in the persisting biologics registry of the German Paediatric Rheumatology Society. Follow-up will last at least 5 years after last exposure of the drug. The registry is active since 2001, already incorporated 1300 JIA patients exposed to TNF inhibitors. The patient will be followed in the JUMBO registry which is instituted by the German Paediatric Rheumatology Society to follow-up adult JIA patients for at least 5 years after last exposure of TNF inhibitors.
    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 Decision2011-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-22
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