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    The EU Clinical Trials Register currently displays   38870   clinical trials with a EudraCT protocol, of which   6391   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-005466-19
    Sponsor's Protocol Code Number:R0002198
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-04
    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 number2013-005466-19
    A.3Full title of the trial
    Cytokine inhibition in Chronic Fatigue Syndrome patients - a pilot study.
    Cytokine inhibitie in patiënten met het chronisch vermoeidheidssyndroom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Inhibition of the immune system in patients with the Chronic Fatigue syndrome.
    Remming van het afweersysteem bij patiënten met het chronisch
    vermoeidheidssyndroom.
    A.3.2Name or abbreviated title of the trial where available
    CiCFS
    CiCFS
    A.4.1Sponsor's protocol code numberR0002198
    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 SponsorRadboudUMC
    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 supportSOBI
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportMöller foundation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud UMC
    B.5.2Functional name of contact pointGeneral Internal Medicine
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 8
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6500 HB
    B.5.3.4CountryNetherlands
    B.5.6E-mailmegan.roerink@radboudumc.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 Kineret 100 mg/0.67ml solution fot injection
    D.2.1.1.2Name of the Marketing Authorisation holderSwedisch Orphan Biovitrium AB
    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 nameAnakinra
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Fatigue Syndrome
    Chronisch Vermoeidheidssyndroom
    E.1.1.1Medical condition in easily understood language
    Chronic Fatigue Syndrome
    Chronisch Vermoeidheidssyndroom
    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
    To investigate the effect on symptomatology of interference with IL-1 inmCFS patients.
    Onderzoeken van het effect van interferentie met IL-1 op de klachten
    van mensen met het chronisch vermoeidheidssyndroom.
    E.2.2Secondary objectives of the trial
    Secondary outcome measures will be:
    • level of functional impairment measured with the Sickness Impact
    Profile (SIP8) total score;
    • physical and social functioning assesses with the subscale physical
    functioning and social functioning of the SF-36;
    • level of psychological distress assessed with the total score on the
    Symptom Checklist-90 (SCL-90);
    • pain severity assessed with a Visual Analog Scale (VAS);
    • cytokine measurement in blood (plasma and blood in Pax-gene tubes)
    and salivary (at protein and mRNA level);
    • cortisol measurement in salivary and hair;
    • microbiome determination in faeces;
    • body temperature and pulse rate.
    Secundaire uitkomstmaten zijn:
    • mate van functionele beperking gemeten met de Sickness Impact
    Profile (SIP) score;
    • psychisch en sociaal functioneren gemeten met de Subscale Physical
    functioning and Social functioning (SF-36);
    • mate van psychische stress gemeten met de totale score op de
    Symptom Checklist-90 (SCL-90);
    • mate van pijn gemeten met de Visual Analog Scale (VAS);
    • cytokine metingen in bloed (plasma en bloed in Pax-gen buizen) en
    speeksel (op het niveau van eiwit en mRNA);
    • cortisol metingen in speeksel en haar;
    • microbioom bepaling in faeces;
    • lichaamstemperatuur en hartfrequentie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet
    all of the following criteria:
    • CDC-diagnosed CFS-patients;
    • female, between 18 and 59 years old;
    • score of >40 on the subscale fatigue severity of the CIS (Checklist
    Individual Strength);
    • marked functional impairment assessed with the Sickness Impact
    Profile (SIP-8) and operationalised as a total score of > 800.
    Inclusiecriteria:
    • CDC gediagnosticeerde CVS patiënten;
    • vrouw, tussen de 18 en 59 jaar oud;
    • score >40 op de Checklist Individual Strength
    • aanzienlijke functionele beperkingen vastgesteld met een score >800
    op de Sickness Impact Profile
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be
    excluded from participation in this study:
    • pregnant or nursing women;
    • women who intend to get pregnant during the study;
    • patients who use or have used psychotropic medication in the past
    month;
    • substance abuse in the past 3 months;
    • patients taking any medication except oral contraceptives and/or
    paracetamol;
    • patients with evident somatic co-morbidity;
    • previous or current engagement in CFS research;
    • inability to understand the nature and the extent of the trial and the
    procedure required;
    • psychiatric co-morbidity assessed with the MINI;
    • any condition, which in the opinion of the investigators might
    interfere with the evaluation of the study objects;
    • current engagement in a legal procedure.
    Exclusiecriteria:
    • zwangere vrouwen of vrouwen die borstvoeding geven;
    • vrouwen die van plan zijn zwanger te raken gedurende de studie;
    • patiënten die psychotropische medicatie hebben gebruikt in de
    afgelopen maand;
    • middelenmisbruik in de afgelopen 3 maanden;
    • patiënten die medicatie gebruiken met uitzondering van orale
    anticonceptiva of paracetamol;
    • patiënten met evidente somatische comorbiditeit;
    • actuele of eerdere betrokkenheid bij CVS onderzoek;
    • onmogelijkheid om de inhoud en gevolgen van het onderzoek te
    kunnen begrijpen;
    • psychiatrische comorbiditeit vastgesteld door middel van de MINI;
    • iedere conditie, welke in de ogen van de onderzoekers kan
    interfereren met de evaluatie van de deelnemers aan het onderzoek;
    • patiënten die gedurende het onderzoek zijn betrokken bij een
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure will be fatigue severity measured with the Checklist Individual Strength (CIS).
    De primaire uitkomstmaat van deze studie is de ernst van
    vermoeidheid gemeten door middel van de Checklist Individual Strength
    (CIS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weekly until 4 weeks, thereafter monthly until 6 months after inclusion.
    Wekelijks tot en met 4 weken, daarna maandelijks tot en met zes
    maanden na inclusie.
    E.5.2Secondary end point(s)
    Secondary outcome measures will be:
    • level of functional impairment measured with the Sickness Impact
    Profile (SIP8) total score;
    • physical and social functioning assesses with the subscale physical
    functioning and social functioning of the SF-36;
    • level of psychological distress assessed with the total score on the
    Symptom Checklist-90 (SCL-90);
    • pain severity assessed with a Visual Analog Scale (VAS);
    • cytokine measurement in blood (plasma and blood in Pax-gene tubes)
    and salivary (at protein and mRNA level);
    • cortisol measurement in salivary and hair;
    • microbiome determination in faeces;
    • body temperature and pulse rate.
    Secundaire uitkomstmaten zijn:
    • mate van functionele beperking gemeten met de Sickness Impact
    Profile (SIP) score;
    • psychisch en sociaal functioneren gemeten met de Subscale Physical
    functioning and Social functioning (SF-36);
    • mate van psychische stress gemeten met de totale score op de
    Symptom Checklist-90 (SCL-90);
    • mate van pijn gemeten met de Visual Analog Scale (VAS);
    • cytokine metingen in bloed (plasma en bloed in Pax-gen buizen) en
    speeksel (op het niveau van eiwit en mRNA);
    • cortisol metingen in speeksel en haar;
    • microbioom bepaling in faeces;
    • lichaamstemperatuur en hartfrequentie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 4 weeks and after 6 months.
    Na 4 weken en na 6 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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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
    Last study visit= 6 months.
    Otherwise in case of:
    • Adverse events.
    • Subject-related reasons, not treatment related reasons:
    o unwillingness to cooperate for reasons not related to the treatment;
    o emergence of an illness of which the severity, duration or required
    treatment violate the conditions of the trial.
    • Administrative reasons:
    o treatment code being broken;
    o essential data (outcomemeasures) are missing and cannot be
    recovered;
    o protocol violation.
    Laatste studie bezoek.
    Anders in geval van:
    • Bijwerkingen.
    • Deelnemer gerelateerde reden:
    o niet bereid verdere behandeling voort te zetten;
    o krijgen van een ziekte waarvan de ernst, duur of benodigde
    behandeling de trial kan schaden.
    • Administratieve reden:
    o behandelings code is gebroken;
    o essentiële data (uitkomstmaten) ontbreken en kunnen niet opnieuw
    worden achterhaald;
    o protocol beschadiging.
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 46
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-02-04. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state46
    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 Decision2014-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
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