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    Summary
    EudraCT Number:2020-001019-26
    Sponsor's Protocol Code Number:202000167
    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:2020-07-14
    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 number2020-001019-26
    A.3Full title of the trial
    [18F]fluor-PEG-folate PET/CT imaging in Giant Cell Arteritis: a pilot study.
    [18F]fluor-PEG-folaat PET/CT beeldvorming in reuscelarteriitis: een pilot studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging of inflamed arteries in giant cell arteritis with a PET/CT scan.
    Afbeelden van ontstoken bloedvaten bij reuscelarteriitis met een PET/CT scan.
    A.4.1Sponsor's protocol code number202000167
    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 SponsorUniversity Medical Center Groningen, Department of Rheumatology and Clinical Immunology
    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 supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportVU Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointCo-ordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressUMCG (HPC: AA21), Hanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031503619185
    B.5.5Fax number0031503619308
    B.5.6E-mailk.s.m.van.der.geest@umcg.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.2.5The 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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluorine-18
    D.3.9.1CAS number 13981-56-1
    D.3.9.3Other descriptive nameFLUORINE-18
    D.3.9.4EV Substance CodeSUB74867
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200
    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 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
    giant cell arteritis
    reuscelarteriitis
    E.1.1.1Medical condition in easily understood language
    giant cell arteritis
    reuscelarteriitis
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    Primary Objective: to evaluate arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.
    Primaire doel: evalueren van arteriële [18F]fluor-PEG-folaat opname op de PET/CT in patiënten met actieve, grote vaten reuscelarteriitis ten tijde van de diagnose en na 9 maanden van reguliere behandeling.
    E.2.2Secondary objectives of the trial
    - Assessment of the relationship between the [18F]fluor-PEG-folate uptake after 9 months of treatment and clinical disease activity at that time point.

    - Assessment of the relationship between the [18F]fluor-PEG-folate uptake after 9 months of treatment and the development of relapses during the first 9 months of treatment.
    - Beoordelen van de relatie tussen [18F]fluor-PEG-folaat opname na 9 maanden behandeling en de ziekteactiviteit op dat tijdstip.

    - Beoordelen van de relatie tussen [18F]fluor-PEG-folaat opname na 9 maanden behandeling en het ontwikkelen van ziekteopvlammingen gedurende de eerste 9 maanden van behandeling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 50 years at time of disease onset
    - Erythrocyte sedimentation rate (ESR) ≥50 mm/hr or C-reactive protein (CRP) ≥ 10 mg/L
    - Clinical symptoms of large vessel GCA (at least one of the following) at time of inclusion: constitutional symptoms (fatigue, fever, weight loss, and/or night sweats), limb claudication, or symptoms of polymyalgia rheumatica (i.e. shoulder and/or hip girdle pain associated with morning stiffness).
    - Imaging findings consistent with large vessel GCA at the time of inclusion (e.g. ultrasound, FDG-PET/CT)
    - 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.
    - Leeftijd ≥ 50 jaar ten tijde van ontstaan van ziekte
    - Bloedbezinking (BSE) ≥50 mm/uur of C-reactive protein (CRP) ≥ 10 mg/L
    - Klinische symptomen suggestief voor grote vaten reuscelarteriitis (minstens een van volgende): constitutionele symptomen (moeheid, koorts, gewichtsverlies, en/of nachtzweten), claudication van ledematen, symptomen van polymyalgia rheumatica (d.w.z. schouder- en/of heupgordelpijn met ochtendstijfheid)
    - Bewijs voor reuscelarteriitis bij beeldvormend onderzoek (bijv. echografie, FDG-PET/CT)
    - Patiënten moeten in staat zijn zich te houden aan de studie afspraken en andere protocol verplichtingen.
    - Patiënten 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
    - Clinical symptoms suggestive of cranial GCA (at least one of the following): new-onset localized headache, scalp tenderness, temporal artery abnormality (thickening, tenderness, and/or decreased pulsation), ischemia-related vision loss, stroke, transients ischemic attack, jaw or tongue claudication (pain upon mastication).
    - Ultrasound findings consistent with cranial GCA (e.g. halo sign in temporal or facial artery).
    - A prior positive temporal artery biopsy.
    - Initiation or dose escalation of systemic glucocorticoid therapy (oral, IM, IV) in the 4 weeks prior to inclusion
    - Initiation or dose escalation of disease-modifying antirheumatic drugs (DMARDs) within 3 months prior to inclusion
    - Treatment with any investigational drug within 3 months prior to inclusion.
    - Females with child bearing potential. Post-menopausal women with >12 months of amenorrhoea are considered to have no child bearing potential. Given the age distribution of patients with GCA, exclusion of females with child bearing potential will not lead to recruitment bias in the study.
    - Research-related radiation exposure (cumulative ≥5 mSv) in the year before inclusion.
    - Klinische symptomen suggestief voor craniële reuscelarteriitis (minstens één van de volgende): nieuwe gelokaliseerde hoofdpijn, gevoelige hoofdhuid, afwijkende arteria temporalis bij lichamelijk onderzoek (verdikt, pijnlijk, verminderd pulserend), ischemisch visusverlies, CVA, TIA, kaak -of tongclaudicatio.
    - Echografische bevindingen suggestief voor craniële reuscelarteriitis (bijv. halo sign in arteria temporalis of facialis).
    - Een eerder positief biopt voor reuscelarteriitis.
    - Start dan wel dosisverhoging van systemisch werkzame glucocorticoiden (oraal, IM, IV) in 4 weken voorgaand aan inclusie
    - Start dan wel dosisverhoging van 'disease-modifying antirheumatic drugs' (DMARDs) in 3 maanden voorgaand aan inclusie
    - Behandeling met een ‘investigational drug’ in de 3 maanden voorgaand aan inclusie.
    - Vrouwen die vruchtbaar zijn. Postmenopauzale vrouwen met > 12 maanden amenorroe worden beschouwd als onvruchtbaar.
    - Onderzoeksgerelateerde blootstelling aan straling (cumulatief ≥5 mSv) in het jaar voorgaand aan inclusie.
    E.5 End points
    E.5.1Primary end point(s)
    Arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.
    Arteriële [18F]fluor-PEG-folaat opname op de PET/CT in patiënten met actieve, grote vaten reuscelarteriitis; en in dezelfde patiënten na 9 maanden van reguliere behandeling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 years
    4 jaar
    E.5.2Secondary end point(s)
    -The relationship between the [18F]fluor-PEG-folate uptake after 9 months of treatment and clinical disease activity at that time point.

    -The relationship between the [18F]fluor-PEG-folate uptake after 9 months of treatment and the development of relapses during the first 9 months of treatment.
    -De relatie tussen [18F]fluor-PEG-folaat opname na 9 maanden behandeling en de ziekteactiviteit op dat tijdstip.

    -De relatie tussen [18F]fluor-PEG-folaat opname na 9 maanden behandeling en het ontwikkelen van ziekteopvlammingen gedurende de eerste 9 maanden van behandeling.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 years
    4 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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 concerned2
    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.
    Laatste visite van laatste proefpersoon.
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Decision2020-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-26
    P. End of Trial
    P.End of Trial StatusOngoing
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