Cytokine Inhibition in Chronic Fatigue Syndrome Patients (CiCFS)
Chronic Fatigue Syndrome
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring Chronic fatigue syndrome, Cytokines, Interleukin-1, Fatigue, Anakinra
Eligibility Criteria
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
- 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 ≥700.
Exclusion Criteria:
- pregnant or nursing women;
- women who intend 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 with respect to disability claims.
Sites / Locations
- RadboudUMC
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Anakinra
Placebo
This therapy will consist of once daily subcutaneous injections (100mg/day) during a period of 4 weeks. Patients will be monitored at week 1 and week 4 after starting medication for development of side effects. Therapy will be stopped in case of severe side effects, interfering disease or pregnancy. During the intervention period, use of co-medication is only allowed when used for ≤14 consecutive days, on the condition that there are no known interactions with anakinra. Oral contraceptives and/or paracetamol can be used without a limitation. During the follow-up period, there are no limitations regarding the use of medication. All co-medication will be registered precisely and reported afterwards.
Patients in the placebo group will also receive once daily subcutaneous injection during a period of 4 weeks. Placebo injections will be identically in appearance compared to the Anakinra injections. Patients in the placebo group will have the same visits and monitoring for side effects as the patients randomized to the other treatment arm. During the intervention period, use of co-medication is only allowed when used for ≤14 consecutive days, on the condition that there are no known interactions with anakinra. Oral contraceptives and/or paracetamol can be used without a limitation. During the follow-up period, there are no limitations regarding the use of medication. All co-medication will be registered precisely and reported afterwards.