To investigate the effect on symptomatology of interference with IL-1 in CFS patients.
ID
Source
Brief title
Condition
- Other condition
- Immune disorders NEC
Synonym
Health condition
chronisch vermoeidheidssyndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be fatigue severity measured with the
Checklist Individual Strength (CIS).
Secondary outcome
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.
Background summary
Chronic fatigue syndrome (CFS) is a medically unexplained syndrome for which no
somatic or pharmacological treatment has been proven effective. Dysfunction of
the cytokine network has been suspected to play a role in the pathophysiology
of CFS. Although derangements of the cytokine network in CFS are controversial,
a major problem is that many studies did not use adequate controls. In
addition, all studies have been performed on peripheral venous blood of the
patients. As cytokines mainly act in the tissues, e.g., the brain, the
information that can be derived from peripheral blood cells is limited. The
only information regarding a role of cytokines in pathophysiology could come
from intervention studies in which pathogenetically important cytokines are
inhibited. A potentially relevant cytokine which can be blocked in humans
without severe side effects is IL-1.
Study objective
To investigate the effect on symptomatology of interference with IL-1 in CFS
patients.
Study design
A randomized placebo controlled study will be performed to determine whether
interference with IL-1 is able to reduce fatigue and disabilities in CFS
patients.
Intervention
After inclusion patients will be randomized to receive one of the following
treatments:
• the interleukin-1 inhibitor Anakinra (IL-1Ra) for 4 weeks (N=25);
• placebo for 4 weeks (N=25).
Study burden and risks
Burden:
• randomization between one of 2 treatment conditions and subsequent treatment
(Anakinra or placebo for 4 weeks)
• pregnancy test at pretest evaluation;
• visit the ECCF at 0 weeks, at 4 weeks and (voluntary) at 6 months after
inclusion;
• collection of blood samples at 0 and 4 weeks after inclusion (25mL);
• collection of saliva at 0 and 4 weeks after inclusion;
• collection of hair at 0 and 4 weeks after inclusion;
• submit faeces at 0 weeks after inclusion;
• bring a neighbourhood control at day 0;
• assessment of fatigue severity at pre-baseline screening, at day 0, week
2,3,4; thereafter monthly follow-up assessments up to 6 months after day 0;
• assessment of all secondary outcome measures (aside from pain) at day 0, week
4 and 6 months after a day 0;
• self-assessment of pulse rate weekly up until 4 weeks after inclusion,
thereafter every month until the end of the study.
Risk:
• Possible side-effects of Anakinra: (transient) irritation at injection site,
rarely development of neutropenia
Benefit:
• The possibility of an effective treatment of CFS in patients treated with
ARA290 or Anakinra.
Reinier postlaan 4
Nijmegen 6525GC
NL
Reinier postlaan 4
Nijmegen 6525GC
NL
Listed location countries
Age
Inclusion criteria
•CDC-diagnosed CFS-patients
•female, between 18 and 59 years old
•fatigue duration <=10 years, or significant increase of complaints during the last 10 years
•CIS (Checklist Individual Strength) >= 40
•marked functional impairment: Sickness Impact Profile (SIP-8) >= 700
Exclusion criteria
•pregnant or nursing women
•women who intent to get pregnant during the study
•fatigue duration >10 years
•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 (major depression, psychosis, eating disorders, anxiety disorders, bipolar disease and post traumatic stress disorder) assessed with the MINI
•live vaccination during the past four weeks
•current engagement in a legal procedure
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-005466-19-NL |
| ClinicalTrials.gov | NCT02108210 |
| CCMO | NL47571.091.14 |