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    Summary
    EudraCT Number:2018-004429-94
    Sponsor's Protocol Code Number:01-19112018
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-06-17
    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 number2018-004429-94
    A.3Full title of the trial
    [18F]PEG-folate PET-CT imaging for monitoring of therapy response in rheumatoid arthritis patients
    [18F]PEG-folaat PET-CT beeldvorming voor de monitoring van response op therapie bij reumatoïde artritis patiënten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Monitoring of respons to therapy in rheumatoid arthritis with the help of a PET scan.
    Monitoring van respons op therapie bij reumatoïde artritis met behulp van een PET scan.
    A.4.1Sponsor's protocol code number01-19112018
    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 SponsorVU Medical Center, department of Rheumatology
    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 supportVU Medical Center, department of Rheumatology
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU Medical Center, department of Rheumatology
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 7057
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1007 MB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number003120444 3432
    B.5.5Fax number0003120444 2138
    B.5.6E-mailj.vanderlaken@vumc.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 No
    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.3.1Product name[18F]PEG-Folate
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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 Yes
    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
    Rheumatoid Arthritis
    Reumatoïde artritis
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    Reumatoïde artritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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 primary objective is to investigate the association between quantitative changes in whole body F-18-PEG Folate PET/CT (Folate PET) after 4 weeks and clinical response to anti-TNF therapy at 26 weeks of treatment in patients with clinically active established |RA.
    Het primaire doel is om de associatie tussen kwantitatieve veranderingen in F-18-PEG folaat PET / CT (folaat PET) na 4 weken en klinische respons op anti-TNF-therapie na 26 weken behandeling bij patiënten met klinisch actieve RA te onderzoeken.
    E.2.2Secondary objectives of the trial
    The secondary objective is to relate quantitative Folate PET outcome after 4 weeks to histological changes in synovial tissue after 4 weeks of anti-TNF treatment (with a particular focus on macrophage infiltration and FRβ expression).
    Het secundaire doel is om de kwantitatieve Folaat PET-uitkomst na 4 weken te relateren aan histologische veranderingen in synoviaal weefsel na 4 weken anti-TNF-behandeling (met een specifieke focus op infiltratie van macrofagen en FRβ-expressie).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients must be at least 30 years of age
    • Diagnosis of rheumatoid arthritis according to the 1987 revised criteria of the American Rheumatism Association (ARA)13 and/or the 2010 ACR/EULAR Rheumatoid Arthritis classification criteria.
    • Patients with clinically active disease as assessed by a physician; with arthritis in at least one knee or ankle joint and have a clinical indication to start with anti-TNF (either Infliximab, Etanercept, Adalimumab or Certolizumab)
    • Prior treatment with one anti-TNF agent is permitted, but may not be a primary failure to any anti-TNF agent (defined as no response within the first 12 weeks of treatment)
    • Treatment with disease modifying anti-rheumatic drugs (DMARDS) and oral corticosteroid up to 10 mg daily is allowed, provided that there is a stable dose for at least 4 weeks prior to inclusion and during the study up to 12 weeks of follow up.
    • Non-steroidal anti-inflammatory drugs (NSAID) is permitted, provided that there is a stable dose for at least 4 weeks prior to inclusion and during the study up to 12 weeks of follow up.
    • Patients must be able to adhere to the study appointments and other protocol requirements
    • Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.
    • Patienten moeten 30 jaar of ouder zijn.
    • Diagnose vanreumatoïde artritis volgens de 1987 gereviseerde criteria van de American Rheumatism Association (ARA)13 en/of de 2010 ACR/EULAR Rheumatoid Arthritis classificatie criteria.
    • Patienten met klinisch actieve ziekte zoals bepaald door een arts; met artritis in ten minste één knie of enkel gewricht en die een klinische indicatie hebben om te starten met anti-TNF(Infliximab, Etanercept, Adalimumab of Certolizumab).
    • Eerdere behandeling met één anti-TNF middel is toegestaan, maar mag niet primair gefaald hebben op een anti-TNF middel (gedefinieerd als geen respons binnen de eerste 12 weken van therapie).
    • Behandeling met disease modifying anti-rheumatic drugs (DMARDS) en orale corticosteroïden tot 10 mg per dag is toegestaan, mits er in de maand voorafgaand aan inclusie en in de eerste 12 weken van de studie een stabiele dosis gebruikt wordt.
    • Non-steroidal anti-inflammatory drugs (NSAID) zijn toegestaan, mits er in de maand voorafgaand aan inclusie en in de eerste 12 weken van de studie een stabiele dosis gebruikt wordt.
    • Patienten moeten in staat zijn om zich te houden aan studie afspraken en andere protocol verplichtingen.
    • Patienten moeten in staat zijn om een geïnformeerde keuze te maken over deelname aan het onderzoek, en moeten toestemming geven voor start van het onderzoek.
    E.4Principal exclusion criteria
    • Use of intramuscular or intravenous corticosteroids within 4 weeks prior to screening.
    • Patients who received methotrexate and folic acid less than 7 days before tracer injection.
    • Treatment with any investigational drug within the previous 3 months
    • Known pregnancy or breast feeding
    • Research related radiation exposure (cumulative ≥5 mSv) in the year before inclusion
    • Het gebruik van intramusculaire of intraveneuze corticosteroïden binnen 4 weken voorafgaand aan de screening.
    • Patiënten die minder dan 7 dagen vóór tracer-injectie methotrexaat en foliumzuur toegediend kregen.
    • Behandeling met onderzoeksmedicatie in de afgelopen 3 maanden
    • Bekende zwangerschap of het geven van borstvoeding
    • Onderzoeksgerelateerde blootstelling aan straling (cumulatief ≥5 mSv) in het jaar voorafgaand aan inclusie.
    E.5 End points
    E.5.1Primary end point(s)
    The association between quantitative changes in Folate PET after 4 weeks of anti-TNF treatment and clinical response to therapy up to 26 weeks of treatment in patients with established RA. Clinical follow-up up to 26 weeks will be regarded as golden standard.
    De associatie tussen de kwantitatieve veranderingen in folaat PET tracer opname in gewricht(en) na 4 weken van anti-TNF behandeling en klinische respons op therapie tot 26 weken van behandeling bij patiënten met gevestigde reumatoïde artitis. Klinische follow-up na 26 weken van behandeling wordt beschouwd als gouden standaard.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two years
    Twee jaar
    E.5.2Secondary end point(s)
    The association between quantitative Folate PET tracer uptake in joint(s) and histological changes in synovial tissue over 4 weeks of anti-TNF treatment (with particular focus on macrophage infiltration, FRβ expression and macrophage polarization status).
    De associatie tussen de kwantitatieve folaat PET tracer opname in gewrichten en histologische veranderingen in synoviaal weefsel na 4 weken anti-TNF behandeling (met bijzondere aandacht voor de infiltratie van macrofagen, FRβ-expressie en macrofaagpolarisatiestatus).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Two years
    Twee jaar
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    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 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 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 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 10
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 state10
    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.
    Geen
    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 Decision2019-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-21
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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