Clinical Trial: Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Moderate and Serious Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis (CFS/ME), Including in Patients With no

Brief Summary: The hypothesis is that a subset of patients with chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME), including also patients with no clinical response after B-cell depletion therapy using the anti-CD20 antibody Rituximab, may benefit from tumor necrosis factor-alpha inhibition using Etanercept as weekly subcutaneous injections.

Detailed Summary:
Sponsor: Haukeland University Hospital

Current Primary Outcome: Symptom alleviation within 12 months follow-up, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: Response of at least six weeks duration, independent on when occuring, during 12 months follow-up. ]

The primary endpoint is defined as moderate or major response of the CFS/ME symptoms, of at least six weeks duration, independent on when during 12 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded.


Original Primary Outcome: Same as current

Current Secondary Outcome: Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. [ Time Frame: At 3, 6, 9, 12 months after start of intervention. ]

The secondary outcome measures are effect on the CFS/ME symptoms, by evaluation at 3, 6, 9, 12 months after start of intervention.


Original Secondary Outcome: Same as current

Information By: Haukeland University Hospital

Dates:
Date Received: November 8, 2012
Date Started: October 2012
Date Completion:
Last Updated: November 30, 2015
Last Verified: November 2015