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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7259   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-004850-40
    Sponsor's Protocol Code Number:01-0712-2017
    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:2018-02-28
    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 number2017-004850-40
    A.3Full title of the trial
    [18F]Fluoride PET-CT imaging for detection and monitoring of bone formation in spondyloarthritis
    [18F]Fluoride PET-CT beeldvorming voor het aantonen en monitoren van botformatie bij spondylartritis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Detection and monitoring of effects of biological therapy on bone formation in patients with Bechterew's disease or psoriatic arthritis with the use of a Positron Emission Tomography (PET) scan.
    Opsporen en vervolgen van effecten van biologicals op botaanmaak bij patiënten met de ziekte van Bechterew of artritis psoriatica met behulp van een Positron Emissie Tomografie (PET) scan.
    A.3.2Name or abbreviated title of the trial where available
    [18F]Fluoride PET in SpA
    [18F]Fluoride PET bij SpA
    A.4.1Sponsor's protocol code number01-0712-2017
    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.4.1Name of organisation providing supportPfizer
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportForeum
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportNovartis
    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 number0031204443432
    B.5.5Fax number0031204442138
    B.5.6E-mailsecr.reumatologie@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.2.5The 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]Fluoride
    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
    Spondyloarthritis (ankylosing spondylitis and psoriatic arthritis)
    Spondylartritis (ziekte van Bechterew en artritis psoriatica)
    E.1.1.1Medical condition in easily understood language
    Spondyloarthritis (ankylosing spondylitis and psoriatic arthritis)
    Spondylartritis (ziekte van Bechterew en artritis psoriatica)
    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 aim is to investigate the therapeutic effects of Secukinumab on bone formation in SpA patients by using [18F]Fluoride PET-CT imaging.
    Het doel is om de therapeutische effecten van Secukinumab op botvorming in SpA patienten door middel van [18F]Fluoride PET-CT beeldvorming te onderzoeken.
    E.2.2Secondary objectives of the trial
    To investigate cellular and molecular pathology in bone formation.
    De cellulaire en moleculaire pathologie in botvorming te onderzoeken.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Patients will receive a PET-CT scan at baseline (before start of Secukinumab or anti-TNF treatment) and a PET-CT scan after 12 weeks of treatment. Additionally, a group of 8 patients included in the sub-study will receive one PET-CT scan and a bone biopsy.
    Patiënten zullen twee PET-CT scans ondergaan; op baseline (voor de start van Secukinumab of anti-TNF therapy) en na 12 weken behandeling. Daarnaast zal een groep van 8 patiënten geincludeerd worden in de sub-studie, waarin zij een PET-CT scan zullen ontvangen en een botbiopsie.
    E.3Principal inclusion criteria
    • Diagnosis of psoriatic arthritis according to the 2006 Classification Criteria for Psoriatic Arthritis (CASPAR) or ankylosing spondylitis according to the modified New York criteria
    • Patients with clinically active disease as assessed by a physician;
    o In PsA defined as clinically active disease with at least one clinically active enthesitis site and a clinical indication to start with Secukinumab
    o In AS defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 4 or higher and a clinical indication to start with Secukinumab.
    • Treatment with disease modifying anti-rheumatic drugs (DMARDS) and 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.
    • Treatment with oral corticosteroids up to 10mg daily 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.
    • Prior treatment with one anti-TNF agent is permitted with the exception of the anti-TNF control PsA group: they will have no prior anti-TNF treatment and have a clinical indication to start anti-TNF treatment.
    • 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.
    • Diagnose van artritis psoriatica volgens de 2006 Classification Criteria for Psoriatic Arthritis (CASPAR) of de ziekte van Bechterew volgens de modified New York criteria.
    • Patienten met klinisch actieve ziekte zoals bepaald door een arts:
    o in PsA gedefinieerd als klinisch actieve ziekte met minimaal een klinisch actieve enthesitis laesie en een klinische indicatie om met Secukinumab te starten.
    o In AS gedefinieerd als een Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score van 4 of hoger en een klinische indicatie om met Secukinumab te starten.
    • Behandeling met disease modifying anti-rheumatic drugs (DMARDS)en non-steroidal anti-infiammatory drugs (NSAID) is toegestaan, mits er in de maand voorafgaand aan inclusie en in de eerst 12 weken van de studie een stabiele dosis gebruikt wordt.
    • Behandeling met orale corticosteroiden tot 10mg per dag is toegestaan, mits er in de maand voorafgaand aan inclusie en in de eerst 12 weken van de studie een stabiele dosis gebruikt wordt.
    • Eerdere behandeling met één anti-TNF middel is toegestaan, met de uitzondering van de anti-TNF controle groep: zij moeten geen eerdere anti-TNF middelen gebruikt hebben, en een klinisch indicatie om te starten met anti-TNF behandeling.
    • Patiënten moeten in staat zijn om zich te houden aan 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
    • Treatment with any investigational drug within the previous 3 months.
    • Pregnancy or breast-feeding
    • Behandeling met onderzoeksmedicatie in de afgelopen 3 maanden.
    • Zwangerschap of het geven van borstvoeding.
    E.5 End points
    E.5.1Primary end point(s)
    Our main endpoint is data collection of the baseline and follow up [18F]Fluoride whole body PET-CT scans from 40 SpA patients. Clinical response to treatment in follow-up assessmenst will be the gold standard.
    Onze primaire uitkomstmaat is het verzamelen van baseline en follow up data van [18F]Fluoride whole body PET-CT scans van 40 SpA patienten. Klinische respons op behandeling in follow up beoordeling zal de gouden standaard zijn.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One year.
    Een jaar.
    E.5.2Secondary end point(s)
    Our secondary endpoint is the histological staining of samples taken by PET-guided bone biopsies from 8 clinically active AS patients.
    Onze secundaire uitkomstmaat is de histologische kleuring van samples afgenomen via PET-begeleide botbiopten van 8 klinisch actieve AS patienten.
    E.5.2.1Timepoint(s) of evaluation of this end point
    One year.
    Een 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 Yes
    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 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 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
    The last visit of the last subject undergoing the trial.
    De laatste visite van de laatste deelnemer van de studie.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 48
    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 Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    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)
    Not applicable
    Niet van toepassing
    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 Decision2018-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-25
    P. End of Trial
    P.End of Trial StatusOngoing
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