E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Fatigue Syndrome |
Chronisch Vermoeidheidssyndroom |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Fatigue Syndrome |
Chronisch Vermoeidheidssyndroom |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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.2.2 | Secondary 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.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.4 | Principal 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.5.1 | Primary 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.5.1.1 | Timepoint(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.5.2 | Secondary 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.5.2.1 | Timepoint(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.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |