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    Summary
    EudraCT Number:2018-003432-72
    Sponsor's Protocol Code Number:DRESS-PS
    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:2018-09-13
    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 number2018-003432-72
    A.3Full title of the trial
    Randomised controlled trial of dose reduction and withdrawal strategies of TNF inhibitors in Psoriatic Arthritis and Axial Spondyloarthritis.
    “Dose REduction Strategy Study of TNF inhibitors in Psoriatic arthritis and axial Spondyloarthritis patients: DRESS-PS.”
    “Onderzoek naar afbouw en stop behandelstrategieën van TNF remmers bij patiënten met artritis psoriatica en axiale spondylartritis”

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose reduction and withdrawal of TNF inhibitors in patients with Psoriatic Arthritis and Axial Spondyloarthritis
    Afbouwen en stoppen van TNF remmers bij patiënten met Artritis Psoriatica en Axiale Spondylartritis.
    A.3.2Name or abbreviated title of the trial where available
    Dose reduction and withdrawal strategies of TNF inhibitors in PsA and axSpA.
    Afbouw en stop behandelstrategieën van TNF remmers in PsA en axSpA.
    A.4.1Sponsor's protocol code numberDRESS-PS
    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 supportSint 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 pointAlfons den Broeder
    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 number0031243659729
    B.5.6E-mailA.denbroeder@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 Tumor Necrosis Factor alpha (TNF-a) Inhibitors: Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie, Pfizer, MSD, UCB Pharma
    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.3.1Product nameAdalimumab, Certolizumab, Etanercept, Golimumab, Infliximab
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adults diagnosed with Psoriatic Arthritis en Axial Spondyloarthritis.
    Volwassenen gediagnosticeerd met artritis psoriatica en axiale spondylartritis.
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis and Axial Spondyloarthritis
    Artritis psoriatica en axiale spondylartritis
    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
    The aim of the study is to compare the proportion of patients with PsA and axSpA having LDA state for at least 6 months, at 12 months between usual care and dose reduction strategy against a prespecified non-inferiority margin In addition, a cost-effectiveness analysis will be performed to assess the cost effectiveness of dose reduction in comparison to usual care.
    Het doel van deze studie is om het aantal patiënten met PsA en axSpA met een rustige ziekteactiviteit voor minstens 6 maanden, na 12 maanden tussen de afbouwstrategie en de standaardzorg groep te vergelijken, met een van tevoren vastgestelde non-inferioriteits marge Daarnaast zal een kosteneffectiviteitsanalyse verricht worden om de kosteneffectiviteit tussen de afbouwstrategie en standaardzorg groep te vergelijken.
    E.2.2Secondary objectives of the trial
    - To determine the proportion of PsA and axSpA patients in the intervention group that can successfully reduce or discontinue TNFi use;
    - To determine the change in PASDAS and ASDAS for each visit in both dose reduction and usual care groups;
    - To determine the incidence of flare in both dose reduction and usual care groups;
    - To determine the functioning in both groups;
    - To determine the cost-effectiveness of dose reduction versus usual care;
    - To determine the proportion of patients using NSAID, corticosteroid or cs/b/tsDMARD’s in both groups;
    - To determine safety of dose reduction (adverse events and infections);
    - To identify baseline factors which can predict successful and maintained dose reduction.
    Vaststellen van:
    - Het aantal PsA en axSpA patiënten in de interventiegroep die de TNF remmers succesvol kunnen afbouwen of stoppen;
    - De verandering in PASDAS en ASDAS voor elke visit in zowel de reductiegroep en de standaardzorg groep;
    - Het voorkomen/incidentie van flare in zowel de reductiegroep en de standaardzorg groep;
    - Het functioneren in beide groepen;
    - Het verschil in kosteneffectiviteit tussen de reductiegroep en de standaardzorg groep;
    - Het aantal patiënten die NSAIDs, corticosteroïden of cs/b/tsDMARD’s in beide groepen;
    - De veiligheid van het afbouwen van TNF remmers (bijwerkingen en infecties);
    - Identificeren van baseline factoren die succesvol en behoud van afbouwen kunnen voorspellen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients are > 18 years of age AND
    - Fulfil the Classification Criteria for Psoriatic Arthritis (CASPAR) and have peripheral SpA of the psoriatic arthritis subtype diagnosed clinically by the rheumatologist and/or fulfil the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA AND
    - Are using full dose, or at least > 50% of the authorized defmed daily dose (DDD), of an origmator or biosimilar TNFi (adalimumab, certolizumab, etanercept, golimumab, infliximab) AND
    - Patients have to have stable LDA, Psoriatic Arthritis Disease Activity Score (PASDAS) s 3 2 and a skin measure of Body Surface Area mvolvement (modified BSA) using a target of 3% as used by rheumatologists in climcal practice for PsA and/or Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2 1 and an absence of active extra-articular symptoms such as Crohn’s disease, uveitis, colitis or psoriasis for axSpA, for at least 6 months, or when formal measurements are not available, judgement of physician and patiënt
    - Patiënten zijn > 18 jaar EN
    - Voldoen aan de classificatie criteria voor artritis psoriatica (CASPAR) en hebben perifere SpA, behorend bij artritis psoriatica, wat klinisch beoordeeld is door de reumatoloog en/of voldoen aan de Assessment of SpondyloArthritis international Society (ASAS) classificatie criteria voor axSpA EN
    - Gebruiken de volledige dosis of minstens > 50% van de geautoriseerde standaarddagdosering (DDD) van een oorspronkelijke of van een biosimilar TNF remmer (adalimumab, certolizumab, etanercept, golimumab, infliximab) EN
    - Patiënten moeten een stabiele lage ziekteactiviteit hebben, Psoriatic Arthritis Disease Activity Score (PASDAS) < 3 2 en Body Surface Area (modified BSA) < 3% wat door de reumatologen in de dagelijkse praktijk voor PsA gebruikt wordt en/of Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2 1 met afwezigheid van extra-articulaire symptomen zoals Morbus Crohn, uveitis, colitis of psoriasis voor axSpA Hieraan moeten ze minsten 6 maanden voldoen, of wanneer formele meetinstrumenten met beschikbaar zijn, zal het door de arts en patiënt beoordeeld moeten zijn
    E.4Principal exclusion criteria
    - Previous recorded unsuccessful dose reduction of TNFi,
    - Comorbidities expected to hamper successful dose reduction (e g Crohns disease, Ulcerative colitis, Psoriasis, Uveitis),
    - Not able to have 12 months follow-up (life expectancy, planned relocation),
    - Not able to measure outcome (language, other limitations)
    - Patiënten waarbij eerder het afbouwen van TNF remmers met succesvol was
    - Patiënten met comorbiditeiten waarvan verwacht wordt dat ze het succesvol afbouwen van TNF remmers zullen verhinderen (e g M Crohn, Colitis Ulcerosa, Psoriasis, Uveitis),
    - Patiënten waarbij 12 maanden follow-up met mogelijk is (levensverwachting, verhuizing)
    - Patiënten waarbij het met mogelijk is om de uitkomstmaat te meten (taal, andere limitaties)
    E.5 End points
    E.5.1Primary end point(s)
    The difference in proportion of patients between dose reduction arm versus usual care who are m LDA state (PASDAS <32 and modified BSA <3% of the skin (PsA)), ASDAS < 2 1 (axSpA) and an absence of active extra-articular symptoms) in the dose reduction arm versus usual care with TNFi at 12 months follow-up, compared to the prespecified non-inferiority margin of 0 2 (20%).
    Vergelijken van het percentage patiënten tussen de afbouwstrategie en de standaardzorg groep dat na 12 maanden nog steeds een lage ziekteactiviteit (PASDAS <32 and modified BSA <3% of the skin (PsA)), ASDAS < 2 1 (axSpA) en afwezigheid van actieve extra-articulaire symptomen) heeft met een van tevoren vastgestelde non-inferioriteits marge (20%).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 maanden
    E.5.2Secondary end point(s)
    -To assess the proportion of patients in the intervention group able to reduce their TNFi dose, able to discontinue TNFi altogether, or not able to reduce TNFi dose without an increase in disease activity, respectively,
    - To compare the differences in efficacy between the dose reduction arm versus usual care with TNFi measured by change in PASDAS and BSA of the skin and/or ASDAS at 3, 6, 9 and 12 months follow-up,
    - To assess the difference in the change from baseline in functionmg measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) and Bath Ankylosing Spondylitis Functional Index (BASFI - axSpA only) between the dose reduction arm versus usual care with TNFi at 3, 6, 9, and 12 months follow-up,
    - To estimate cost effectiveness ratio of the protocolised dose reduction/withdrawal strategy of TNFi compared to usual care,
    - To compare (dosage and) proportion of patients using NSAID, corticosteroid’s or cs/b/tsDMARDs between intervention and usual care group at 12 months follow up,
    - To predict m the intervention group which baseline factors (including [change in] serum drug levels and antidrug antibody levels) are associated with successful and maintained dose reduction,
    - To compare the difference in cumulative incidence of flare between the dose reduction arm versus usual care at 12 months follow up,
    - To assess the safety of this strategy with respect to proportion of patients developing adverse events with special attention to allergie (injection) reactions and infections
    - Vaststellen van het aantal PsA en axSpA patiënten in de interventie groep die TNF remmers succesvol kunnen afbouwen, stoppen of met kunnen afbouwen zonder toename van ziekteactiviteit,
    - Vaststellen van het verschil in werkzaamheid tussen de afbouwstrategie en standaardbehandel groep met TNF remmers, gemeten door PASDAS en BSA van de huid en/of ASDAS op 3, 6, 9 en 12 maanden follow-up,
    - Vaststellen van het verschil in verandering vanaf baseline van de Health Assessment Questionnaire Disability Index (HAQ-DI) and Bath Ankylosing Spondylitis Functional Index (BASFI - alleen axSpA) tussen de afbouwstrategie en standaardbehandel groep met TNF remmers op 3, 6, 9 en 12 maanden follow-up,
    - Vaststellen van kosten-effectiviteits ratio van de afbouwstrategie van TNF remmers vergeleken met standaardzorg,
    - Vaststellen van het aantal patiënten dat gebruik maakt van een NSAID, corticosteroiden of cs/b/tsDMARD's tussen de afbouwstrategie en standaardbehandel groep op 12 maanden follow-up,
    - Vergelijken van het verschil in cumulatieve incidentie van flare tussen de afbouwstrategie en standaardbehandel groep op 12 maanden follow-up,
    - Voorspellen welke baseline factoren (inclusief (verandering) in serum drug en antidrug antibody levels) in de afbouwstrategie groep geassocieerd zijn met het succesvol en behouden afbouwen,
    - Vaststellen van de veiligheid van deze afbouwstrategie met betrekking tot het aantal patiënten die bijwerkingen ontwikkelen, meer bepaald allergische (injectie) reacties en infecties
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6, 9, 12 months
    3, 6, 9, 12 maanden
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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
    Patiënten ontvangen dezelfde TNF remmers die ze al gebruiken= afbouwstrategiestudie vs standaardzorg
    Patients will receive the same TNFi that they already use= dose reduction strategy vs usual care
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    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 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: 187
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 47
    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 state234
    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)
    No specific plans. If patients, following the dose reduction strategy, have a low disease activity than they can choose to continue. If not, than they can go on with the usual care and further treatment desicions will be made according to local protocol.
    Geen specifieke plannen. Als patiënten die de afbouwbehandelstrategie volgen een lage ziekteactiviteit hebben, kunnen zij ervoor kiezen om hiermee door te gaan. Indien dit niet het geval is, zullen ze weer de standaardzorg ontvangen, beslissingen over de behandeling zullen dan volgens het lokale protocol gemaakt worden.
    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 Decision2018-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-23
    P. End of Trial
    P.End of Trial StatusOngoing
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