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    Summary
    EudraCT Number:2015-002809-12
    Sponsor's Protocol Code Number:YLB113-002
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-02
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2015-002809-12
    A.3Full title of the trial
    A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis
    A.4.1Sponsor's protocol code numberYLB113-002
    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 SponsorYL Biologics Ltd
    B.1.3.4CountryJapan
    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 supportYL Biologics Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationYL Biologics Ltd
    B.5.2Functional name of contact pointHead - Regulatory
    B.5.3 Address:
    B.5.3.1Street AddressGat No. 1156, Village Ghotwade
    B.5.3.2Town/ cityMulshi Taluke, Pune
    B.5.3.3Post code412 115
    B.5.3.4CountryIndia
    B.5.4Telephone number912066549816
    B.5.6E-mailakshayaodak@lupin.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 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 nameYLB113
    D.3.2Product code YLB113
    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 codeYLB113
    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.3.2Product code Enbrel
    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.3.9.4EV 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
    Rheumatoid Arthritis
    E.1.1.1Medical condition in easily understood language
    Arthritis
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid 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
    20% improvement according to American College of Rheumatology
    criteria (ACR20) at Week 24 of dosing
    E.2.2Secondary objectives of the trial
    1. ACR20 response rate at Weeks 4, 8 and 12 of dosing
    2. ACR50 and ACR70 response rate at Weeks 4, 8, 12 and 24 of dosing
    3. Improvement in the DAS28 (Disease activity score using 28 tender
    and swollen joint counts, C-Reactive Protein (CRP)/ Erythrocyte
    Sedimentation Rate (ESR) and the subject's global assessment)
    response rate at Weeks 4, 8, 12 and 24 of dosing
    4. Adverse events, Physical examination, Vital signs, ECG, Clinical
    laboratory examination and Injection site assessment
    5. Immunogenicity at Weeks 4, 8, 12, 24, 36, 44 and 52 of dosing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Male or female adults ≥ 18 and ≤ 75 years of age at the time of
    informed consent.
    (2) Patients diagnosed with RA according to the 2010 American College
    of Rheumatology (ACR)/ European League Against Rheumatism (EULAR)
    classification criteria for RA1 and are capable of providing written
    informed consent to participate in the study.
    (3) Patients with ≥ 6 tender joints and ≥ 6 swollen joints (based on the
    Swollen Joint Count [SJC] using 66 joints and Tender Joint Count [TJC]
    using 68 joints) and a DAS28 score ≥ 3.2.
    (4) Patients classified as Global Functional Assessment Class I, II, or III,
    according to the revised ACR criteria.

    Please refer to protocol for remaining criteria
    E.4Principal exclusion criteria
    (1) Patients with known hypersensitivity to Etanercept or any other
    components of the study drug.
    (2) Patients allergic to latex (the needle cap on the Etanercept prefilled
    syringe contains latex, which may cause allergic reactions in individuals
    sensitive to latex).
    (3) Patients suffering from acute or chronic, localized or disseminated
    infections (bacterial/fungal/viral) or sepsis, or patients with a history of
    recurring infections, or those who are at an increased risk of developing
    infections or sepsis (and those with positive test results for β-D-glucan
    only for Japan) within 3 months prior to screening.
    (4) Patients with active tuberculosis (TB), prior history of unsuccessfully
    treated TB, latent TB, or those who are at risk of developing TB and
    patients who are not negative for TB tests (e.g., T-SPOT® TB or
    QuantiFERON®-TB Gold test/ appropriate test).
    (5) Patients with a history of septic arthritis of native joints within 12
    months prior to screening, or any prior history of septic arthritis of a
    prosthetic joint.
    (6) Patients diagnosed with other rheumatic diseases, autoimmune
    disease, connective tissue disease, or immune deficiencies (e.g.,
    psoriasis, psoriatic arthritis, primary Sjogren's syndrome, systemic lupus
    erythematosus, or demyelinating diseases such as multiple sclerosis).
    (7) Patients with active or prior history of malignancies (except for
    successfully treated non-metastatic basal or squamous cell carcinoma of
    the skin and carcinoma insitu of the cervix).
    (8) Patients with a prior history of blood dyscrasias.
    (9) Patients with a history of alcohol, drug, or chemical abuse in the past
    2 years prior to screening.
    (10) Patients who received any live or attenuated vaccines within 4
    weeks of screening.
    (11) Patients previously treated with any other biologic response
    modifiers for any auto-immune indication (including but not limited to
    tocilizumab, adalimumab, anakinra, abatacept, infliximab, rituximab,
    golimumab, etanercept, certolizumab and tofacitinib).
    (12) Patients with serious systemic infections (e.g., patients who test
    positive for hepatitis B surface antigen [HBsAg], hepatitis B core
    antibody [HBcAb], hepatitis C virus [HCV], or human immunodeficiency
    virus [HIV]).

    Please refer to protocol for remaining criteria
    E.5 End points
    E.5.1Primary end point(s)
    Patients will be considered to have achieved an ACR20 , improvement if:
    compared to baseline (Day 1), they achieve a 20% decrease in SJC, 20%
    decrease in TJC and 20% improvement in 3 of the following 5 measures:
    •Patient assessment of pain (VAS)
    •Patient global assessment of disease activity (VAS)
    •Physician global assessment of disease activity (VAS)
    •CRP or ESR
    •HAQ-DI
    To assess ACR response for a patient, the same acute phase reactants
    i.e. either ESR or CRP should be used throughout the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stage A - week 24
    Stage B - week 52
    Stage C - week 52
    E.5.2Secondary end point(s)
    •ACR20 response rate at Weeks 4, 8 and 12 of dosing
    •ACR50 response rate at Weeks 4, 8, 12 and 24 of dosing
    •ACR70 response rate at Weeks 4, 8, 12 and 24 of dosing
    An improvement in the DAS28 scores at Weeks 4, 8, 12 and 24 of dosing.
    The DAS28 score is calculated using results from a 28 joint subset of the
    66/68 SJC/TJC.
    The DAS28 is a composite score (ranging from 0- 9.4) calculated using
    the results of the 28 joint subset of the 66/68 SJC/TJC, CRP levels
    (mg/L) or ESR levels (mm/hr), and the patient's global assessment of
    diseases activity (0- 100 scale). The DAS28 is calculated using the
    following formula , :
    DAS28 based on CRP
    0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*pt
    global VAS + 0.96
    DAS28 based on ESR
    0.56*sqrt(TJC 28) + 0.28*sqrt(SJC28) + 0.70*Ln(ESR) + 0.014* pt
    global VAS

    To assess DAS28 scores for a patient, the same DAS assessment
    parameters (based on either ESR or CRP) should be used throughout the
    study.
    The DAS28 scores indicating high disease activity are > 5.1; moderate
    disease activity ≥ 3.2 to ≤ 5.1; low disease activity, < 3.2 and remission,
    < 2.6.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Stage A - week 24
    Stage B - week 52
    Stage C - 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 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
    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 Yes
    E.8.1.7Other No
    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 concerned7
    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
    Czech Republic
    Hungary
    India
    Japan
    Latvia
    Romania
    Spain
    Ukraine
    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.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 500
    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)
    Treatment options will be discussed with the patient as per the routine practice/care and the patients will be shifted to appropriate standard of care by principal investigator.
    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 Decision2016-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-02
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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