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    The EU Clinical Trials Register currently displays   44132   clinical trials with a EudraCT protocol, of which   7324   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:2012-005026-30
    Sponsor's Protocol Code Number:SB4-G31-RA
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-08
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2012-005026-30
    A.3Full title of the trial
    A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy
    A.4.1Sponsor's protocol code numberSB4-G31-RA
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSamsung Bioepis Co., Ltd.
    B.1.3.4CountryKorea, Republic of
    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 supportSamsung Bioepis Co., Ltd.
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles Limited
    B.5.2Functional name of contact pointQuintiles Contact Centre
    B.5.3 Address:
    B.5.3.1Street AddressThe Alba Campus, Rosebank
    B.5.3.2Town/ cityLivingston
    B.5.3.3Post codeEH54 7EG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+1862261 3634
    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 nameSB4 (etanercept biosimilar)
    D.3.2Product code SB4
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.2Current sponsor codeSB4
    D.3.9.3Other descriptive nameTNFR:Fc
    D.3.9.4EV Substance CodeSUB01984MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 RoleComparator
    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 Limited
    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.3.1Product nameEnbrel®
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.3Other descriptive nameTNFR:Fc
    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 number50
    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
    Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    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 17.1
    E.1.2Level SOC
    E.1.2Classification code 10021428
    E.1.2Term Immune system disorders
    E.1.2System Organ Class 10021428 - Immune system disorders
    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 this study is to demonstrate the equivalence of SB4 to Enbrel® at Week 24, in terms of American College of Rheumatology 20% response criteria (ACR 20) response rate in subjects with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
     To evaluate efficacy of SB4 compared to Enbrel using relevant efficacy endpoints other than ACR 20 at Week 24 in subjects with moderate to severe RA despite MTX therapy
     To evaluate safety and tolerability of SB4 compared to Enbrel in subjects with moderate to severe RA despite MTX therapy
     To evaluate pharmacokinetics of SB4 compared to Enbrel in subjects with moderate to severe RA despite MTX therapy
     To evaluate immunogenicity of SB4 compared to Enbrel in subjects with moderate to severe RA despite MTX therapy
    The secondary objectives for the open-label, extension period are:
    • To evaluate long-term safety and tolerability of SB4 in subjects with RA treated previously with SB4 or Enbrel
    • To evaluate long-term immunogenicity of SB4 in subjects with RA treated previously with SB4 or Enbrel
    • To evaluate long-term efficacy of SB4 in subjects with RA treated previously with SB4 or Enbrel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are male or female aged 18–75 years at the time of signing the consent form.
    2. Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria
    3. Have more than or equal to six swollen joints, more than or equal to six tender joints (from the 66/68 joint count system) at Screening and Randomisation and either erythrocyte sedimentation rate (Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 1.0 mg/dL at Screening.
    4. Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10–25 mg/week given orally or parenterally for at least 4 weeks prior to Screening.
    5. Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 2 months after the last dose of investigational product (IP).
    Subjects must meet all of the following criteria to be enrolled in the
    open-label, extension period:
    1. Have completed the scheduled Week 52 visit of the randomised, double-blind period of SB4-G31-RA study, may benefit from SB4 treatment at the discretion of the Investigator and are willing to
    participate in the open-label, extension period.
    2. Must be able to provide informed consent for the open-label, extension period, which must be obtained prior to the first administration of IP for the open-label, extension period.
    E.4Principal exclusion criteria
    1. Have been treated previously with any biological agents including any tumour necrosis factor inhibitor.
    2. Have a known hypersensitivity to human immunoglobulin proteins or other components of Enbrel or SB4.
    3. Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus.
    4. Have a current diagnosis of active tuberculosis
    5. Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.
    6. Have any of the following conditions
    a. Other inflammatory or rheumatic diseases.
    b. History of any malignancy within the previous 5 years prior to Screening
    c. History of lymphoproliferative disease including lymphoma.
    d. History of congestive heart failure
    e. Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
    f History of demyelinating disorders.
    Subjects meeting any of the following criteria must not be enrolled in the
    open-label, extension period:
    1. Have been withdrawn from SB4-G31-RA Study for any reason.
    2. Have had any significant medical conditions, such as an occurrence of a serious adverse event (SAE) or intolerance of SB4 or Enbrel during the 52 weeks of randomised, double-blind period which may render the subjects undesirable to participate in the study at the discretion of the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the study is the ACR 20 response at Week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
     The ACR 20 response at Week 52
     The ACR 50 response and ACR 70 response at Week 24 and Week 52
     The numeric index of the ACR response (ACR-N) at Week 24 and Week 52
     The area under the curve (AUC) of ACR-N up to Week 24
     The disease activity score based on a 28 joint count (DAS28 score) at Week 24 and Week 52
     The European League Against Rheumatism response at Week 24 and Week 52
     The AUC of the change in DAS28 from Baseline up to Week 24 Major clinical response (ACR 70 response for 6 consecutive months) at Week 52
     Change from baseline in modified Total Sharp Score at Week 52
    The secondary endpoints for the open-label, extension period:
    • The ACR20, ACR50 and ACR70 response at Week 76 andWeek 100
    • The ACR-N at Week 76 and Week 100
    • The change in DAS28 score from Week 0 at Week 76 andWeek 100
    • The EULAR response at Week 76 and Week 100
    • The change from Week 0 in mTSS at Week 100
    E.5.2.1Timepoint(s) of evaluation of this end point
     The ACR 20 response at Week 52
     The ACR 50 response and ACR 70 response at Week 24 and Week 52
     The numeric index of the ACR response (ACR-N) at Week 24 and Week 52
     The area under the curve (AUC) of ACR-N up to Week 24
     The disease activity score based on a 28 joint count (DAS28 score) at Week 24 and Week 52
     The European League Against Rheumatism response at Week 24 and Week 52
     The AUC of the change in DAS28 from Baseline up to Week 24 Major clinical response (ACR 70 response for 6 consecutive months) at Week 52
     Change from baseline in modified Total Sharp Score at Week 52
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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
    Open label Extension period added as Protocol Amendment 3.1
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    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
    Bulgaria
    Colombia
    Czech Republic
    Hungary
    India
    Korea, Republic of
    Lithuania
    Mexico
    Poland
    Ukraine
    United Kingdom
    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.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 520
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    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 state270
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 423
    F.4.2.2In the whole clinical trial 596
    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)
    None
    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 Decision2013-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-06
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