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    Summary
    EudraCT Number:2020-005730-15
    Sponsor's Protocol Code Number:GO-TEST-FINALE
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-11
    Trial 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 number2020-005730-15
    A.3Full title of the trial
    GOut TrEatment STrategy (GO TEST) FINALE study, a multicentre pragmatic randomized superiority trial of continuation versus cessation of urate lowering therapies in gout in remission.
    Het vergelijken van stoppen of doorgaan met urinezuurverlagende therapie in jichtpatiënten in remissie; een pragmatische gerandomsieerde strategie studie (GO TEST FINALE).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research into continuation or cessation of urate lowering therapies in gout patients in remission.
    Onderzoek met urinezuurverlagende therapie bij jicht. Levenslang doorgaan of is (tijdelijk) stoppen mogelijk?
    A.3.2Name or abbreviated title of the trial where available
    GO TEST FINALE
    A.4.1Sponsor's protocol code numberGO-TEST-FINALE
    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 SponsorSint Maartenskliniek
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZonMw /ZE&GG, Sint Maartenskliniek
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSint Maartenskliniek
    B.5.2Functional name of contact pointJunior Investigator
    B.5.3 Address:
    B.5.3.1Street AddressHengstdal 3
    B.5.3.2Town/ cityUbbergen
    B.5.3.3Post code6574 NA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031243272558
    B.5.6E-maili.peeters@maartenskliniek.nl
    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 Allopurinol, Desuric, Adenuric
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz B.V., Kyowa Kirin Holdings B.V., Menarini International Operations Luxembourg S.A. 1, Avenue
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAllopurinol
    D.3.9.1CAS number 315-30-0
    D.3.9.4EV Substance CodeSUB05338MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBENZBROMARONE
    D.3.9.1CAS number 3562-84-3
    D.3.9.4EV Substance CodeSUB05743MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFEBUXOSTAT
    D.3.9.1CAS number 144060-53-7
    D.3.9.4EV Substance CodeSUB25382
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gout, arthritis urica
    E.1.1.1Medical condition in easily understood language
    Gout
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018627
    E.1.2Term Gout
    E.1.2System Organ Class 10027433 - Metabolism and nutrition 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 test whether the proportion of patients in remission during the last 6 months of follow up is higher for a T2T strategy (in which the urate lowering therapies allopurinol, benzbromarone and/or febuxostat are continued) compared to a T2S stop strategy (in which the urate lowering therapies allopurinol, benzbromarone and/or febuxostat are tapered to stop).
    E.2.2Secondary objectives of the trial
    - To assess non-inferiority of T2S compared to T2T in case superiority of T2T over T2S is not shown in the primary analysis
    - To assess the incremental cost-effectiveness of T2T over T2S treatment strategy in euro per QALY gained
    - To assess the between group difference in the incidence of gout flares during the follow-up period of 24 months
    - To assess the proportion of participants that require reintroduction of ULT in the T2S strategy group
    - To evaluate the between group difference in Patient-Reported Outcome Measures (PROMs)
    - To assess the between group difference in types and frequency of adverse events during the follow-up period of 24 months
    - To assess the between group difference in use of ULT and flare medication (colchicine, NSAIDS and/or glucocorticoids)
    - To assess the between group difference in prescribed medication compared with refill rates and self-reported adherence during the follow-up period of 24 months.

    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 sub study of the GO TEST FINALE concerns the creation of a bio bank consisting of blood samples. No pharmacological sub studies are performed.
    E.3Principal inclusion criteria
    To be eligible to participate in this study, a participant must meet all of the following criteria:
    - Patients with clinical diagnosis of gout and/or fulfilling the 2015 ACR-EULAR gout criteria
    - Use of ULT (allopurinol, benzbromarone and/or febuxostat)
    - Achieved remission for ≥ 12 months based on adapted preliminary gout remission criteria
    o Free of flares and/or clinically apparent tophi during the last 12 months
    o Serum urate ≤0.36 mmol/l at baseline and all values in the last 12 months should not be >0.36 mmol/l
    o Pain due to gout <2 using a 10-point Likert-type scale at baseline
    o Patient global assessment of gout disease activity <2 using a 10-point Likert-type scale at baseline
    - Age ≥18 years and mentally competent
    - Signed written informed consent
    E.4Principal exclusion criteria
    A potential participant will be excluded from participation in this study if one of the following criteria has been met:
    - Not being able to speak, read or write Dutch well enough
    - No ability to measure the outcome of the study in the participant (e.g. life expectancy <2 years, planned relocation out of reach of study center)
    - A strong contra-indication for glucocorticoids, NSAIDs AND colchicine, as this hampers flare treatment
    - Use of ULT (also) for any other indication than gout (for example nephrolithiasis)
    - Currently taking regular glucocorticoids, and/or colchicine, and/or interleukine-1 inhibitors for any diagnosis and/or the use of regular NSAID intake for gout activity
    - A history of myocardial infarction or stroke in the past six months and/or congestive heart failure NYHA class III or IV
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the difference in proportion of patients fulfilling an adapted version of the preliminary remission criteria for gout (no tophi, no flares, NRS pain due to gout < 2, NRS gout disease activity <2) over the last six months of 24 months follow up between the T2T and T2S strategy group. The adaptation consist of omitting the SU target < 0.36 prerequisite, as this surrogate outcome measure is of course not a realistic goal when comparing T2T and T2S.

    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome is measured in the last six months of 24 month follow-up (month 18-24).
    E.5.2Secondary end point(s)
    - Non-inferiority of T2S compared to T2T with a predefined NI-margin of 0.08, in case superiority of T2T over T2S is not shown in the primary analysis.
    - The incremental cost-effectiveness of T2T over T2S treatment strategy in euro per QALY gained, by using the results of EQ-5D-5L, iMCQ, iPCQ and medication costs
    - The between group difference in the incidence (cumulative incidence and incidence density rate) of gout flares during the follow-up period of 24 months
    - The proportion of participants that require reintroduction of ULT in the T2S group during the 24 month follow-up period
    - The between group difference in SU change during the total follow-up time and particularly at baseline and at the end of follow-up at 24 months
    - The between group difference in PROMs at baseline and after 24 months by using the EQ-5D-5L, HAQ-II, NRS pain, and NRS global health
    - The between group difference in types and frequency of adverse events, with special focus on change in renal function (CKD-EPI), incidence of cardiovascular events during the follow-up period of 24 months
    - The between group difference in use of ULT and flare medication (colchicine, NSAIDs and/or glucocorticoids)
    - The (between group) difference in prescribed medication compared with refill rates during the follow-up period of 24 months
    - An overview of predictors for successful ULT cessation in the T2S strategy group including clinical, radiological, immunological and genetic variables.
    - The creation of a biobank consisting of serum, plasma and PAXgene samples of gout patients in remission (dis)continuing ULT
    E.5.2.1Timepoint(s) of evaluation of this end point
    Measurements take place at baseline, month 12 and 24. Two weeks after ULT discontinuation an extra blood visit is scheduled. Flares are monitored throughout the entire follow-up period; patients are required to call when a flare occurs and flares are monitored monthly by a digital questionnaire.
    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 No
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    It mainly concerns the comparison of two ULT treatment strategies in which allopurinol, benzbromarone and/or febuxostat are used.
    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 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
    Patients either continue their urate lowering therapy or discontinue the ULT based on randomization.
    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 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 Yes
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    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 state310
    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)
    If in patients in the T2S arm after 24 months, ULT is not restarted, it can be decided in consultation with the treated rheumatologist to discontinue the medication. If T2T turns out to be superior, patients will restart ULT and will be followed by a rheumatologist.
    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 Decision2021-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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