Norwegian Science trials Etanercept as treatment for chronic fatigue syndrome (CFS/ME
Norwegian Science trials Etanercept as treatment for chronic fatigue syndrome (CFS/ME)
A short introduction of the studyprotocol to the Dept. of Oncology, Haukeland University Hospital, Bergen, Norway by Olav Mella and ystein Fluge named: English Tumor necrosis factor-alpha inhibitor etanercept as treatment for chronic fatigue syndrome/ myalgic encephalopathy (CFS/ME), including for patients with no response to treatment with the anti-CD20 antibody Rituximab
The open single trial is ongoing and ends in 2014 after the last patient 24 moths follow-up. This study has to be viewed as a pilot study. Data from this study can form the basis for future studies and treatment aimed at confirming possible findings. The study protocol is released and supervised by Norwegian National Committee for Ethics in Medical Research (REK). EudraCT number: 2011-006069-16.
The pathophysiology of CFS is not clear and highly debated. Studies aimed at identifying biomarkers for CFS patients may greatly benefit the identification of patients. Furthermore, insights into the pathophysiology of disease may facilitate novel therapies. This trial is aimed for patients that did not respond (non-responders) to the Rituximab treatment.
Maximim duration of treatment of a subject according to the protocol:
etanercept 50 mg injections subcutaneously (SC) once every week, for a maximum of 52 weeks.
Participations: 15 patients who fulfill Fakuda- criteria recruited from the Rituximab-trial.
Main objective of the trial:
Patients self-recording of CFS/ME symptom improvement and quality of life issues during 12 months follow-up. The primary endpoint is selfreported major symptom improvement lasting at least for six consecutive weeks, independent of time after intervention during followup.
Single such periods of major improvement, and the sum of these during 12 months follow-up, are recorded.
-Self-reported symptom improvement at 3, 6, 9, 12 months follow-up after start of intervention.
-Duration of maximal continous major response during follow-up.
-Toxicity during follow-up.
Inclusion criteria:
-CFS/ME according to Fukuda criteria, moderate and serious.
-Age 18-66 years
Exclutions criteria:
-Fatigue not fulfilling criteria for CFS/ME.
-Pregnancy or lactation.
-Previous malignancy (except basal cell carcinoma or cervical dysplasia)
-Previous long-term immunosuppressive treatment (ciclosporin,
mycophenolate mofetil, azathioprine)
-demyelination disease
-cardiac failure
-endogenous depression
-lack of ability to adhere to protocol
-known multi-allergy with risk from etanercept injection
-reduced liver function or kidney function
-HIV infection or viral hepatitis. Latent tuberculosis.
Etanercept (Embrel) is classified as an immunosuppressant drug. A relatively new drug (1988), etanercept blocks the effects of an immune agent called tumor necrosis factor -alpha (TNF-a) by binding to it and stopping it from interacting with bodys cells. TNF-a is an important cytokine the body uses to amplify the inflammatory response produced during infection. It has been called the master regulator of the immune response. TNF-a produces many of the symptoms associated with infection including fever and pain.
KTS_4_2011_Clinical trial: Link:
http://totoneimbehl.wordpress.com/2...udie/kts_4_2011_clinical-trial-soknad-utland/
Note: This is a new trial to see if Embrel can be an alternative for non-responders. There is some info om this drug in this forum so take a serach.
--------------
The second that was mention here were a annual repport from the Univeristy Hospital in Bergen Haukeland that descrebed the reserch om patogenesis og ME called project 911557 where there are hunting for biomarkers. And hopefully they will find the auto-antibody "needle in a haystack"
In the Fluge et. al (2011) PLosONE study there draw bloodsampels and contiued after in the fallow-up study that still is ongoing.
I will assume Fluge or Mella will talk about the biobank and this prosject in Invest in ME conferance i May and the way foreward in next Rituximab-trials.
The biobank is starting to look impressing and they do collaborate with A Kogelnick, Klimas and so on - This is gooood stuff folks
