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    Summary
    EudraCT Number:2013-004569-16
    Sponsor's Protocol Code Number:B1801359
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-11-18
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2013-004569-16
    A.3Full title of the trial
    A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis
    A.4.1Sponsor's protocol code numberB1801359
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 10017
    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., 235 East 42nd Street, New York, NY 10017
    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 number+1800718 1021
    B.5.5Fax number+1303739 1119
    B.5.6E-mailclinicaltrials.govcallcenter@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 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 nameEtanercept
    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/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 Yes
    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
    Rheumatoid Arthritis
    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
    To assess the immunogenicity of etanercept manufactured using the high capacity process administered weekly in subjects with RA over 24 weeks.
    E.2.2Secondary objectives of the trial
    To evaluate the overall safety and efficacy of etanercept manufactured using the high capacity process administered weekly for 24 weeks.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The aim of the sub-study is to assess whether patient reported outcomes (PROs) collected electronically on subject’s own mobile devices are equivalent to the same PROs collected on paper. Only subjects with allowable personal mobile devices will be able to participate in the study.
    E.3Principal inclusion criteria
    1.Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    2.Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3.Subject is literate and able to complete the protocol-specified questionnaires.
    4.Either the subject or a designee must be capable (according to the investigator’s judgment) of administering the SC investigational product and must be able to store all investigational product under required storage conditions or must be able to come to the study site for administrations where the investigational product may be stored on behalf of the subject.
    5.Male and female ≥18 years of age at the time of consent.
    6.Male and female subjects who are of childbearing potential must agree to use a highly effective method of contraception throughout the study and for atleast 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
    • Female subjects mus tmeet at least one of the following criteria to be considered not of childbearing potential:
    • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    •Have medically confirmed ovarian failure or;
    •Achieved post-menopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormonelevel within the laboratory’s reference range for postmenopausal females.
    7.Female subjects of childbearing potential must have negative urine pregnancy test results based on the screening visit and baseline visit tests. This includes subjects who are menstruating at the time of the visit and/or who are not sexually active.
    8.Meets the 2010 ACR criteria for RA(see Appendix 1).
    9.Active disease as defined as DAS28 ≥3.2 and presence of atleast 4 tender joints and 4 swollen joints at screening and baseline visits.
    10.Screening laboratory results must demonstrate:
    •Aspartate aminotrasferase / alanine aminotrasferase (AST, ALT) <2times the upper limit of normal;
    •Hemoglobin >8.5g/dL;
    •Platelet count >125,000/cmm;
    •White blood cell (WBC) count >3500cells/cmm;
    •Serum creatinine ≤2mg/dL.
    E.4Principal exclusion criteria
    1.Received any previous treatment with ETN.
    2.Received MTX dose greater than 25 mg/week, or change in dose or route within 6 weeks of first dose of investigational product.
    3.Dose change inpermitted nonbiological DMARDs within 4 weeks of first dose of investigational product.
    4.Received cyclophosphamide, cyclosporine, or azathioprine within 6 months of the first dose of investigational product.
    5.Received TNF antagonist (eg,a TNF monoclonal antibody or a soluble TNF-receptor) or any other biologic treatment for RA within 12 weeks of first dose of investigational product.
    6.Received any biologic B-cell depleting agent (eg,rituximab) within 2 years of first dose of investigational product.
    7.Received intra-articular (IA); soft tissue; or bolus intramuscular (IM) orintravenous (IV) treatment with corticosteroids within 4 weeks of first dose of investigational product.
    8.Received oral corticosteroids >10 mg/day of prednisone (or equivalent), or change in dose within 2 weeks of first dose of investigational product.
    9.Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greater than the maximum recommended dose per local label.
    10.Received any live (attenuated) vaccines within 4 weeks before the first dose of investigational product.
    11.Serious infection (infection associated with hospitalization and/or parental (IV or IM) anti-infective agents) within 4 weeks before first dose of investigational product.
    12.Active infection at the time of the screening visit and /or baseline visit. Certain minor active infections (ie,vaginitis, tinea, etc) could be allowed on a case-by-case basis only after approval from the study physician clinician.
    13.Active tuberculosis (TB), or evidence of untreated latent or active TB:
    a.Local country guidelines should be followed for appropriate TB screening and prophylaxis in the setting of anti-TNF therapy, including a minimum of:
    •A chest radiograph, to be performed at the screening visit and read locally by a qualified reader unless a chest radiograph has been done within 12 weeks before the screening visit and the report is available and included in the subject’s source documents. If required by local regulations, a chest x-ray taken within 6 months of the screening visit may be used as long as the report is available and included in the subject’s source documents;
    •Objective TB testing, such as QuantiFERON® or purified protein derivative (PPD) depending on what is available and acceptable per local guidelines. Testing requirements in Section 6.1 Screening Procedure #9 Chest radiograph and TB testing:must be adhered to.
    b.Active TB:
    •Subjects with current or recent (within 2 years before the screening visit) active TB infection are excluded.
    •Subjects with a history of active TB more than 2 years before the screening visit and with documentation of completing an adequate regimen of anti-TB therapy may be considered for enrollment after discussion with the sponsor’s Clinical team.
    c.Latent TB:
    •Subjects with evidence of latent TB infection may be allowed only if local guidelines are followed for prophylactic therapy and if TB chemoprophylaxis has been either adequately completed per local guidelines or initiated at least 4 weeks before the baseline visit. The screening period may be extended to 6 weeks when TB prophylactic treatment is necessary. Subjects who have not completed chemoprophylaxis per local guidelines at the time of the screening visit must agree to continue to completion.
    •For subjects who started chemoprophylaxis within 3 weeks prior to the screening visit or start it during the screening period, additional blood samples for ALT and AST must be drawn between 3-4 weeks after initiating chemoprophylaxis. The results must be reviewed prior to enrollment.
    14.Any clinically relevant concurrent medical conditions, including: a.Uncompensated congestive heart failure, Class III or IV heart failure defined by the New York Heart Association classification, or any episode of acute congestive heart failure within 6months before screening visit;
    b.Uncontrolled hypertension (defined as screening or baseline systolic blood pressure >160 mm Hg or screening diastolic blood pressure >100 mm Hg);
    c.Myocardial infarction within 12 months before the screening visit;
    For the complete list of Exclusion Criteria see the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of subjects developing etanercept ADAs through week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    Secondary Endpoints
    • The percentage of subjects developing neutralizing antibodies at weeks 12 and 24.
    • Frequency of adverse events (AEs), serious adverse events (SAEs), serious infections, injection site reactions and safety laboratory assessments.
    • ACR20, ACR50 and ACR70 at weeks 12 and 24.
    • DAS28 at weeks 12 and 24.
    • HAQ at weeks 12 and 24.
    Exploratory Endpoint
    • The impact of ETN ADA status on clinical safety and efficacy assessments, and steady state ETN concentration.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints listed in the Secondary end points list.
    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 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 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 No
    E.8.1.2Open Yes
    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 Yes
    E.8.2.3.1Comparator description
    Open label
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Croatia
    Germany
    Greece
    Hungary
    Italy
    Mexico
    Poland
    Russian Federation
    Serbia
    Slovakia
    South Africa
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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 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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 180
    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)
    Once a subject’s participation in the study has ended, ETN will no longer be supplied to the subject by the investigative site and/or sponsor.
    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 Decision2015-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-18
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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
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