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    Summary
    EudraCT Number:2011-005448-87
    Sponsor's Protocol Code Number:B1801315
    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:2012-04-12
    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 number2011-005448-87
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)
    COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH
    ETANERCEPT PLUS DMARD(S)
    A.4.1Sponsor's protocol code numberB1801315
    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.
    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.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 Yes
    D.2.1.1.1Trade name Enbrel® 50 mg Solution for Injection in Pre-filled Syringe
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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 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.3.9.4EV 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.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
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    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
    To compare the maintenance of efficacy of the combination of ETN 50 mg once weekly plus MTX (± other DMARDs) therapy with that of MTX (± other DMARDs) at Week 52 in subjects with moderately to severely active RA who have achieved LDA (DAS28 ESR<3.2) after 24 weeks of therapy with open label ETN 50 mg once weekly plus MTX (± other DMARDs) in a treat to target paradigm.
    E.2.2Secondary objectives of the trial
    • To assess the clinical efficacy of the treatment regimens during Periods 1 and 2.

    • To assess the maintenance of remission (DAS28<2.6) at Week 52 in those subjects who achieved remission after 24 weeks therapy with open label ETN 50 mg once weekly plus MTX (+ DMARDs).

    • To assess the improvement in quality of life achieved and maintained by the treatment regimens over 52 weeks.

    • To assess the improvement in physical function achieved and maintained by treatment regimens over 52 weeks.

    • To assess the safety of the treatment regimens over 52 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team prior to subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    • 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.
    • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    Period 1 Inclusion Criteria - Subjects must meet all of the following inclusion criteria to be eligible for enrollment in Period 1 of the study:
    1. Subject is 18 to 70 years of age at the time of consent (eligible on the day of the 18th birthday and ends the day prior to their 70th birthday).
    2. The subject has a minimum 1 year history/diagnosis of RA based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
    3. Subject must have active RA as defined below despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.
    4. Active RA is defined as: (a) disease activity score based on a 28 joint count (DAS28 ESR) >=3.2 and at least 1 of the following at screening and baseline: ≥6 tender joint count (TJC) and ≥6 swollen joint count (SJC) or ESR≥28 mm/hour and (b)HS-C-reactive protein (CRP) ≥3.5 mg/L at screening.
    5. Subject has a functional status of Class I, II, or III as defined by 1991 ACR revised criteria.
    6. Women of childbearing potential must have had a negative serum pregnancy test at screening. Additionally, a urine test must be performed prior to administration of first dose of study medication, Week 52 and Early Discontinuation visit
    7. Male and female subjects of childbearing potential must agree to use a medically accepted highly effective method of contraception throughout the study and for 3 months 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.
    8. Female subjects who are not of childbearing potential (ie, meet at least one of the following criteria):
    • 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 FSH level within the laboratory reference range for postmenopausal females.
    9. Subject must be able to self inject drug or have a designee who can do so and be able to store study medication as required or must be able to come to study site where the study medication may be stored.
    10. Active and latent TB must be ruled out by screening for tuberculosis (TB) in accordance with local country guideline. A Quantiferron test must be performed unless not available. Subjects with recent exposure to active TB must be evaluated by a qualified physician to rule out Tuberculosis.
    11. Subject is literate and able to complete questionnaires.
    Period 2 Inclusion Criteria - The subject must meet all of the following criteria to be randomized into Period 2 of the study:
    1. Subject has completed Period 1 of the study.
    2. Subject has a DAS28 <3.2 at Week 24.
    3. Subject must be willing to continue stable dose of all RA medication subject is using at Week 24 through Week 52 (except when dose adjustment is needed for an adverse event).
    E.4Principal exclusion criteria
    Period 1 Exclusion Criteria:
    1. Subjects, who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the trial.
    2. Subjects who used any of the following systemic treatments during washout periods:
    (a) Oral corticosteroid dose of prednisone >7.5 mg/day or a change in dose w/in 28 days of baseline (BL)
    (b)Treatment with >1 NSAID w/in 14 days at BL
    (c) MTX dose > 25 mg/week, or change in dose w/in 28 days of BL
    (d) Subjects allowed to continue the following: SZ, HCQ, & LEF. All other non-biologic DMARDs & biologic DMARDs must have been discontinued > 2 months prior to Week 0
    (e) Any biologic B cell depleting agent w/in 2 years of Week 0.
    3. known or suspected allergy, hypersensitivity, or contraindication to ETN, its excipients, or other compounds related to this class of medication.
    4. received any live vaccine w/in 4 weeks prior to BL.
    5. abnormal hematology or blood chemistry profile during screening (SC) period. If SC lab tests are abnormal, repeat to confirm results. Results from SC visit must be available at BL visit. BL lab results are not required prior to first dose, but if results subsequently show that the subject does not meet these exclusion levels & is confirmed upon retest, subject must be withdrawn from study.
    • White blood cell (WBC) count ≤3.5 x 10 to the power of 9/L;
    • Hemoglobin level ≤85 g/L or ≤5.3 mmol/L;
    • Hematocrit ≤27%;
    • Platelet count ≤125 x 10 to the power of 9/L;
    • Serum creatinine level ≥175 µmol/L (≥1.98 mg/dL);
    • AST or ALT level ≥2 times the lab’s upper limit of normal.
    6. active & latent TB: Follow local guidelines for appropriate TB SC in the setting of anti-TNF therapy, including a minimum of a chest radiograph & objective TB testing. A PPD of >5 mm should be considered positive for TB unless local guidelines for testing of immunocompromized (subjects with RA) subjects is available & different. (a) Subjects with current or recent (w/in 2 years of SC) active TB infection are excluded (b) Subjects with history of active TB > 2 years ago & with documentation of completing an adequate regimen of anti TB therapy may be considered for enrollment after discussion with sponsor (c)Subjects with known latent TB infection may be allowed only if local guidelines are followed for prophylactic therapy & if TB chemoprophylaxis has been adequately completed or initiated at least 4 weeks prior to Week 0 visit.
    7. received TB chemoprophylaxis during SC &has had ALT and/or AST >2x upper limit of normal [ULN] during this period. Subjects diagnosed with TB & started chemoprophylaxis during SC period, additional blood samples for ALT & AST must be drawn between 3-4 weeks after initiating chemoprophylaxis. Results need to be reviewed prior to randomization.
    8. serious infection w/in 1 month prior to Week 0 visit.
    9. active infection at time of the SC visit and/or Week 0 visit, including systemic fungal infections.
    10. clinically relevant concurrent medical conditions.
    11. anticipating surgical procedure during study period.
    12. participating in other studies involving investigational drug(s) (Phases 1-4) w/in 3 months of study.
    13. pregnant females or those with a positive pregnancy test result at SC or BL; breastfeeding females; males & females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 3 months after last study dose .
    14. can satisfactorily complete the study
    15. severe acute or chronic medical or psychiatric condition, substance abuse or lab abnormality that may increase the risk associated with study participation or IP administration or may interfere with the interpretation of study results
    16. illiterate.
    Period 2 Exclusion Criteria
    1.Subject has had a dose of prednisone >7.5 mg/day (or equivalent) or dose changed w/in 14 days before the randomization visit (Week 24).
    2. Subject has had an oral MTX dose that has changed w/in 8 weeks before the Week 24 randomization visit (with the exception of a hold on the dose due to an AE). 3. Subject taking prohibited medications.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who remained in LDA (DAS28 ESR<3.2) at Week 52, among those who have achieved LDA at Week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    E.5.2Secondary end point(s)
    • Proportion of subjects who remained in remission (DAS28 ESR<2.6) at Week 52, among those who have achieved remission at Week 24.
    • Proportion of subjects in LDA or remission (by both DAS28 ESR and DAS28 CRP scores) at each visit during Period 1 & Period 2.
    • Change from baseline in the DAS28 (-CRP and ESR) score at each visit during Period 1 and Period 2.
    • Time-to-flare or loss of efficacy (loss of LDA plus ≥0.6 unit worsening in DAS28 ESR score) during Period 2.
    • Proportion of subjects achieving European League Against Rheumatism (EULAR) good and or moderate responses (by both DAS28 ESR and DAS28 CRP scores) at each visit during Period 1 and Period 2.
    • Proportion of subjects achieving LDA or remission at each visit during Period 1 and 2 based on CDAI and SDAI each visit during Period 1 and 2.
    • Change of CDAI and SDAI at each visit during Period 1 and 2.
    • Proportion of subjects achieving ACR 20, ACR 50, ACR 70 and ACR 90 (by 66/68 joint counts) during Period 1 and Period 2 at each visit.
    • Change in the tender and swollen joint counts at each visit during Period 1 and Period 2 (using 28 joint count as well as 66/68 joint counts).
    • Change in the Physician Global Assessment at each visit during Period 1 and Period 2.
    • Change in the Subject Global Assessment, including morning stiffness (measured in minutes) at each visit during Period 1 and Period 2.
    • Change in the Subject General Health visual analog scale (VAS), and Pain VAS at each visit during Period 1 and Period 2.
    • Change in CRP and ESR at each visit during Period 1 & Period 2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study and at 52 weeks
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Note: period 1 is open label
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Argentina
    Brazil
    China
    Colombia
    Czech Republic
    Egypt
    Hungary
    India
    Malaysia
    Mexico
    Philippines
    Poland
    Romania
    Russian Federation
    Saudi Arabia
    Slovakia
    South Africa
    Taiwan
    Thailand
    Turkey
    Ukraine
    United Arab Emirates
    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
    LSLV
    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 months0
    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 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: 304
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 124
    F.4.2.2In the whole clinical trial 320
    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 Decision2012-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-27
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