Chronic Fatigue Syndrome
Conditions
Interventions
Trade Name: Kineret 100 mg/0.67ml solution fot injection
Product Name: Anakinra
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Sub
Sponsors
RadboudUMC
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 46 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect on symptomatology of interference with IL-1 inmCFS patients.;Secondary Objective: 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.;Primary end point(s): The primary outcome measure will be fatigue severity measured with the Checklist Individual Strength (CIS).;Timepoint(s) of evaluation of this end point: Weekly until 4 weeks, thereafter monthly until 6 months after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: After 4 weeks and after 6 months. | — |
Countries
Netherlands
Contacts
Public ContactGeneral Internal Medicine
Radboud UMC
Outcome results
None listed