Creating a thread specifically for discussion of the potential of the IL-1 inhibitor Anakinra/Kineret as a treatment for ME/CFS (I hope I'm not double-posting, found mentions of this study but no specific thread)
http://clinicaltrials.gov/show/NCT02108210
Cytokine Inhibition in Chronic Fatigue Syndrome Patients (CiCFS)
Radboud University
Purpose
Rationale: 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 the possible role of cytokines in the pathophysiology of CFS 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. Although it is plausible that these cytokines play a role in CFS, there is limited evidence for this.
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.
Study population: Female CFS patients without psychiatric co-morbidity will be included in this study. Patients of the outpatient clinic of the Department of General internal medicine and the Expert Centre for Chronic Fatigue (ECCF) will be asked to participate in the study. Patients will be asked to bring a healthy neighbourhood control to their first study visit.
Intervention: After inclusion patients will be randomized to receive one of the following treatments:
Secondary outcome measures will be:
Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for
primary outcome measure)
Experimental: Anakinra
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.
http://clinicaltrials.gov/show/NCT02108210
Cytokine Inhibition in Chronic Fatigue Syndrome Patients (CiCFS)
Radboud University
Purpose
Rationale: 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 the possible role of cytokines in the pathophysiology of CFS 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. Although it is plausible that these cytokines play a role in CFS, there is limited evidence for this.
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.
Study population: Female CFS patients without psychiatric co-morbidity will be included in this study. Patients of the outpatient clinic of the Department of General internal medicine and the Expert Centre for Chronic Fatigue (ECCF) will be asked to participate in the study. Patients will be asked to bring a healthy neighbourhood control to their first study visit.
Intervention: After inclusion patients will be randomized to receive one of the following treatments:
- interleukin-1 inhibitor Anakinra (IL-1Ra) for 4 weeks (N=25);
- placebo for 4 weeks (N=25).
Secondary outcome measures will be:
- level of functional impairment measured with the Sickness Impact Profile (SIP8) total score;
- physical and social functioning assessed 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 saliva (at protein and mRNA level);
- cortisol measurement in saliva and hair;
- microbiome determination in faeces;
- body temperature and pulse rate.
Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for
primary outcome measure)
Experimental: Anakinra
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.