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    Summary
    EudraCT Number:2010-020077-16
    Sponsor's Protocol Code Number:B1801031
    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:2010-11-17
    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 number2010-020077-16
    A.3Full title of the trial
    A MULTICENTRE, 12 WEEK DOUBLE BLIND PLACEBO CONTROLLED RANDOMIZED STUDY OF ETANERCEPT ON A BACKGROUND NSAID IN THE TREATMENT OF ADULT SUBJECTS WITH NON RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WITH A 92 WEEK OPEN LABEL EXTENSION
    AZ NSAID HÁTTÉRTERÁPIA MELLETT ALKALMAZOTT ETANERCEPT TÖBB KÖZPONTBAN FOLYÓ, 12 HETES, KETTŐS VAK, PLACEBO-KONTROLLOS, VÉLETLENSZERŰ BESOROLÁSOS VIZSGÁLATA RÖNTGENNEL NEM KIMUTATHATÓ AXIÁLIS SPONDILARTRITISZBEN SZENVEDŐ FELNŐTT BETEGEKNÉL, 92 HETES NYÍLT KITERJESZTETT SZAKASSZAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of Early Structural Changes in Patients with Anklosing Spondyloarthritis
    Korai Strukturális Változások Vizsgálata Axiális Spondilartritiszben Szenvedő Betegek Esetében
    A.4.1Sponsor's protocol code numberB1801031
    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 number001303739 1119
    B.5.6E-mailClinicalTrials.gov_Inquiries@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 holderWyeth Europa 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 185243690
    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 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
    Axial Spondyloarthritis (AxSpA)
    E.1.1.1Medical condition in easily understood language
    Early ankylosing spondyloarthritis
    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 10051265
    E.1.2Term Spondyloarthropathy
    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
    The primary objective of this study is to compare the efficacy of ETN against placebo in improving symptoms of early non-radiographic axial SpA at 12 weeks when added to a background NSAID at the optimal anti-inflammatory dose.
    E.2.2Secondary objectives of the trial
    1. To assess the efficacy and safety of ETN + background NSAID over 104 weeks;
    2. To compare the effect of ETN 50 mg once weekly versus placebo on inflammation seen in MRI of the spine at 12 weeks when added to a background NSAID at the optimal anti-inflammatory dose;
    3. To compare the quality of life between those subjects treated with ETN 50 mg once weekly versus placebo over 12 weeks when added to a background NSAID at the optimal anti-inflammatory dose.
    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 before subjects are included in the study.
     Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable 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.
     Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Diagnosis of axial spondyloarthritis, as defined by the ASAS criteria. Duration of symptoms.of >3 months and <5 years at the time of consent.
    2. Active symptoms defined by a BASDAI ≥4 at the screening visit.
    3. Axial symptoms of back pain with a less than favorable response to current intake of an NSAID at the optimal tolerated dose as determined by the investigator. Subjects must have failed at least 2 NSAIDs (including the current one) taken separately at the optimal tolerated dose with a total combined duration of >4 weeks.
    4. Subject must be taking a stable dose of an NSAID for at least 14 days before baseline.
    5. Female or male 18 years or older but less than 50 years at the time of consent.
    6. In the opinion of the investigator, subject is a reasonable candidate for treatment with etanercept.
    7. No contraindication to MRI examination (metal implants or inability to lay flat for 30-60 minutes for example).
    8. Negative serum pregnancy test taken at screening, negative urine pregnancy test taken at baseline and negative serum pregnancy test collected at baseline.
    9. Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or post menopausal to use a highly effective method of birth control for the duration of the study.
    10. Ability to self-inject drug or have a designee who can do so.
    11. Ability to store injectable test article under refrigerated conditions.
    12. Demonstrates an adequate screening for tuberculosis (TB) in accordance with local country guideline.
    13. Subject is able to complete health outcomes assessments and test article diary.

    Main Inclusion Criteria Period 2
    1. Successfully completed Period 1.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
    2. Any previous treatment with a tumor necrosis factor-alpha (TNF-α) inhibitor, B/T cell inhibitor or other biologic or immunosuppressive agent for a condition other than IBD.
    3. Subject is currently being treated or had previous treatment within 6 months for IBD with any tumor necrosis factor-alpha (TNF-α) inhibitor or any other immunosupressant.
    4. Any orthopedic or medical condition that can cause chronic back pain (different than SpA) such as spondylodiscitis, tumor or advance discopathy.
    5. Evidence of IBD flare within 6 months of baseline.
    6. Evidence of current or recent episodes of uveitis within 6 months of baseline.
    7. Radiological sacroiliitis grade is 3-4 unilaterally or grade 2 bilaterally as defined by the NY criteria. Only results from the central imaging reader will determine eligibility. Historical x-rays (obtained within 4 months of screening) may be utilized, however these subjects must exhibit radiological sacroilitis grade 0-1 unilaterally or grade 0 bilaterally.
    8. Subject has a known or suspected allergy, hypersensitivity, or contraindication to ETN, its excipients, or other compounds related to this class of medication.
    9. Subject has concurrent treatment with more than 1 NSAID within 14 days at baseline. Aspirin use, at daily doses up to 325 mg if indicated for cardiovascular protection is permissible and will not be counted as an additional NSAID.
    10. Subject has had the dose of NSAID that changed within 14 days before baseline.
    11. DMARDS other than methotrexate, sulfasalazine and hydroxychloroquine within 4 weeks of baseline.
    12. Subject has had a dose of prednisone >10 mg/day (or equivalent) or has had a dose changed within 4 weeks before baseline.
    13. Subject has received an intra-articular, intravenous, intramuscular, or subcutaneous (SC) corticosteroid within 4 weeks before baseline.
    14. Subject is a pregnant or breastfeeding woman.
    15. Has current or recent (within 2 years of screening) active TB infection.
     Local country guidelines should be followed for appropriate TB screening in the setting of anti-TNF therapy, including a minimum of a chest radiograph and objective TB testing such as purified protein derivative [PPD] or Quantiferon depending on what is acceptable per local guidelines.
    16. Untreated latent TB.
     Subjects with known latent TB infection may be allowed only if local guidelines are followed for prophylactic therapy and if TB chemoprophylaxis has been adequately completed or initiated at least 4 weeks prior to screening.
    17. Received TB chemoprophylaxis during screening and has had ALT and/or AST >2x upper limit of normal [ULN] during this period.
     For subjects that have been diagnosed with TB and started chemoprophylaxis during the screening period, additional blood samples for ALT and AST must be drawn between 3- 4 weeks after initiating chemoprophylaxis. The results need to be reviewed prior to randomization.
    18. Serious infection (infection associated with hospitalization and/or intravenous antibiotics) within 1 month before test article administration.
    19. Active infection at the time of the screening visit and/or the 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.
    20. Participation in other studies with a therapeutic active component within 3 months before the current study begins and/or during study participation. (Participation in non-interventional or retrospective studies might be permitted following consultation with the Pfizer Clinical team.)
    21. Planned elective surgery during Period 1.
    22. Subject received any live vaccines (attenuated vaccines) within 4 weeks before baseline.
    23. Subject is illiterate.
    24. Subject has an abnormal hematology or blood chemistry profile during the screening period. Refer to Protocol for management of exclusionary lab values at baseline.
     White blood cell (WBC) count ≤3.5 x 109/L;
     Hemoglobin level ≤85 g/L or ≤5.3 mmol/L;
     Hematocrit ≤27%;
     Platelet count ≤125 x 109/L;
     Serum creatinine level ≥175 μmol/L (≥1.98 mg/dL);
     Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥2 times the laboratory’s upper limit of normal.
    25. Subject has any clinically relevant concurrent medical conditions (refer to Protocol for full list).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the proportion of subjects who achieve ASAS 40 at week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 (End of Double Blind Treatment Period)
    E.5.2Secondary end point(s)
    1. Proportion of subjects who achieve ASAS 40 at time points other than 12 weeks;
    2. Proportion of subjects who achieve ASAS 20;
    3. Proportion of subjects who achieve ASAS 5/6;
    4. Changes from baseline in ASDAS;
    5. Proportion of subjects with ASAS partial remission;
    6. Time to ASAS partial remission;
    7. Changes from baseline in Subject Assessment of Disease Activitiy (VAS);
    8. Changes from baseline in the VAS Physician Global Assessment;
    9. Changes from baseline in VAS nocturnal and total back pain over time;
    10. Changes from baseline in the BASFI and its components;
    11. Changes from baseline in the BASDAI and its components;
    12. Proportion of subjects who achieved BASDAI 20 and BASDAI 50;
    13. Changes in BAS-G;
    14. Changes from baseline in spinal mobility as measured by BASMI (and its individual components), and occiput-to-wall distance, and chest expansion;
    15. Changes in inflammation at week 12 as measured by MRI of the spine at week 12;
    16. Changes from baseline in tender and swollen joint counts (44 count);
    17. Changes from baseline on dactylitis and enthesitis score (MASES);
    18. Changes from baseline in the acute phase reactants C Reactive Protein (CRP) and Erythrocyte sedimentation rate (ESR);
    19. Health Outcomes Assessments using the following instruments: WPAI, HADS, EQ-5D MFI, SF 36, ASQoL, ASWIS, MOS Sleep, MFI, PASS, and MCII.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints are evaluated at all in clinic study visits (visit 1-16 or early discontinuation)
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    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
    Period 1 is controlled, Period 2 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Belgium
    Colombia
    Denmark
    Finland
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Netherlands
    Spain
    Taiwan
    United Kingdom
    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
    As per protocol.
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days25
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 200
    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)
    For the purposes of this study, test article will be defined as ETN injections and Placebo-for-ETN injections. Once a subject’s participation in the study has ended, test article will no longer be supplied to the subject by the sponsor and the patient and his/her physician will discuss and decide on the appropriate treatment regimen for the patient post study.
    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 Decision2011-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-03
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