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    Summary
    EudraCT Number:2012-002458-21
    Sponsor's Protocol Code Number:MK8259-012-00
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-03
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-002458-21
    A.3Full title of the trial
    Open-label, Phase 4 Study, investigating the Incidence of Extra-Articular Manifestations in Subjects with Ankylosing Spondylitis treated with Golimumab
    Open-label fase 4 onderzoek, dat het optreden van Extra-articulaire manifestaties bestudeert bij personen met de ziekte van Bechterew die worden behandeld met Golimumab.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label, Phase 4 Study, investigation of the frequency of Extra-Articular exposure in patients with Ankylosing Spondylitis treated with Golimumab
    A.3.2Name or abbreviated title of the trial where available
    GO-EASY
    A.4.1Sponsor's protocol code numberMK8259-012-00
    A.5.4Other Identifiers
    Name:CCMO dossier numberNumber:NL 40935-048-12
    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 SponsorMERCK SHARP & DOHME B.V.
    B.1.3.4CountryNetherlands
    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 supportMERCK SHARP & DOHME B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMERCK SHARP & DOHME B.V.
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressWaarderweg 39
    B.5.3.2Town/ cityHaarlem
    B.5.3.3Post code2003 PC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3123515 3416
    B.5.6E-mailmelika.el.harbachi@merck.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 Simponi
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 INNGOLIMUMAB
    D.3.9.1CAS number 476181-74-5
    D.3.9.4EV Substance CodeSUB25638
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ankylosing Spondylitis
    (Bechterew disease)
    Ziekte van Bechterew
    E.1.1.1Medical condition in easily understood language
    inflammation of the sacroiliac joints and spine
    gewrichtsontsteking van de wervelkolom
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10002557
    E.1.2Term Ankylosing spondylitis and other inflammatory spondylopathies
    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
    Determine the difference in the incidence rate of uveitis in subjects with Ankylosing Spondylitis (AS), before and after treatment with golimumab
    E.2.2Secondary objectives of the trial
    - Determine the difference in the incidence rate of new onsets or flares of IBD and psoriasis in AS patients before treatment and after the start of golimumab
    - Determine the effectiveness of golimumab on AS disease activity, as assessed by BASDAI 50% and ASDAS in routine daily practice.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Each subject should not have received golimumab before the study.
    2. Each subject is prescribed golimumab according to routine daily practice.
    3.Each subject must be able to provide retrospective data concerning EAM episodes with a recall period of at least 12 months prior to anti-TNF use.
    4. Each subject must be willing and able to provide written informed consent for the study. The legal representative (e.g. parent or guardian) for a subject unable to provide independent consent may provide written informed consent for the subject.
    5. Each subject must be ≥ 18 years of age. A subject may be of either sex, any race/ethnicity.
    6. Each subject must have definite AS according to the modified New York criteria in the Netherlands.
    7. Each subject must be candidate for treatment with anti-TNF according to the ASAS consensus.
    8. Each subject must be able to adhere to dose and visit schedules.
    E.4Principal exclusion criteria
    1. Any exclusion criterion as stated in the SPC for golimumab
    2. The subject has used any investigational biological or chemical agents within 30 days or 2 half-lives (whichever is longest) of screening.
    E.5 End points
    E.5.1Primary end point(s)
    is to determine the difference in the annual incidence rate of uveitis attacks in AS patients before treatment and after the start of golimumab
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day -14 through -1
    Day 1
    Day 28
    Month 3
    Month 6
    Month 9
    Month 12
    E.5.2Secondary end point(s)
    - Determine the difference in the incidence rate of new onsets or flares of IBD and psoriasis in AS patients before treatment and after the start of golimumab
    - Determine the effectiveness of golimumab on AS disease activity, as assessed by BASDAI 50% and ASDAS in routine daily practice.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day -14 through -1
    Day 1
    Day 28
    Month 3
    Month 6
    Month 9
    Month 12
    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 No
    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
    effect of golimumab on different events
    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 No
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state100
    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 Decision2012-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-30
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