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. ]
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. ]
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